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1.
Diabetes Metab Syndr Obes ; 17: 2221-2234, 2024.
Article in English | MEDLINE | ID: mdl-38854444

ABSTRACT

Purpose: The study aimed to investigate the efficacy and safety of SophorOx® (LN-OS-22) on oxidative stress and body composition in adults with excessive body weight and obesity. Participants and Methods: The 56-days randomized, double-blind, placebo-controlled, parallel-group, multi-centric clinical trial had individuals aged 30-60 years with body mass index (BMI) ≥25 to ≤34.9 kg/m2. 68 participants were randomly allocated to LN-OS-22 or placebo groups. The primary outcome was improvement in the oxidative stress. Secondary outcomes were changes in plasma lipopolysaccharide (LPS) and serum malondialdehyde (MDA) levels, weight and waist circumference, inflammatory markers, and quality of life. Results: At day 56, a statistically significant change in the 8-Isoprostane levels between LN-OS-22 vs placebo was observed (p = 0.0222). As compared to placebo, at the end of study, statistically significant reductions were demonstrated in body weight, waist circumference and BMI in the LN-OS-22 group (p < 0.0001). Also, a statistically significant change when compared to placebo for the energy/stamina domain (p = 0.0300) of the Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) questionnaire was depicted in LN-OS-22 group. Conclusion: The study demonstrates that LN-OS-22 was effective in reducing the oxidative stress, anthropometrics and improving the quality of life in individuals with overweight and obesity.

2.
J Family Med Prim Care ; 13(2): 607-612, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38605764

ABSTRACT

Context: Hypertension is the leading cause of mortality and disability-adjusted life year (DALY) all over the world. World Health Organization defines quality of life (QOL) as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns. Aims: The study was aimed to compare the the QOL of adult hypertensive patients with healthy study subjects and to determine the factors associated with poor QOL among the hypertensive subjects. Materials and Methods: A community-based cross-sectional study was conducted from January 2021 to June 2022 in Gautam Budh Nagar District. The study was carried out among 250 hypertensive patients and 50 healthy persons based on World Health Organization-Quality of Life-BREF questionnaire Manual. Statistical Analysis Used: Data collected were entered and statistically analyzed using statistical software (SPSS-22). Results: Overall QOL and general health scores were significantly lower among hypertensive subjects showing worsening of QOL among diseased persons (P value <0.001). Factors significantly associated with poor overall QOL were low educational status (P value <0.001), home makers (P value <0.001), lower socio-economic class (P value < 0.001), and subjects with co-morbidities (P value <0.001). Conclusion: The findings revealed that QOL was poor among the hypertensive subjects as compared to healthy subjects.

3.
J Family Med Prim Care ; 13(2): 780-786, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38605804

ABSTRACT

Background: Ageing is a universal process. It is influenced by a person's genetic makeup, lifestyle, and environmental factors. Nutrition plays a significant role in modulation of ageing. In developing countries like India, the health and nutritional status of the elderly population is not satisfactory. Objectives: The current study was done to assess undernutrition amongst the elderly population and to find the various associations with sociodemographic factors and social determinants. Materials and Methods: This cross-sectional study was done from February 2023 to July 2023 in rural area of District Gautam Buddha Nagar, Uttar Pradesh. The elderly participants who were 60 years of age and more and who met the inclusion criteria were selected by simple random sampling technique for the study. Undernutrition was assessed by Mini Nutritional Assessment Tool (MNA). Result: Out of the total of 400 elderly persons, 18% were found to be undernourished and 38% were at risk of undernutrition. The association between undernutrition and age group, gender, occupation, family type, living arrangements that is staying with family or not, financial dependence, any co-morbid illness, smoking, and physical activity was found to be significant. Conclusion: The present findings reveal that undernutrition is not an uncommon problem in the elderly, and further studies are needed in this regard.

4.
J Family Med Prim Care ; 13(2): 758-763, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38605795

ABSTRACT

Background: Reproductive tract infections (RTIs) and gynaecological morbidities constitute a significant proportion of morbidities in women of the reproductive age group. Objective: To find out the proportion of reproductive age group women in an urban resettlement colony having the symptoms of gynaecological morbidities and RTI/sexually transmitted infection (STI) and to explore the healthcare seeking behaviour of the women during such ailments. Materials and Methods: A community-based cross-sectional study was conducted from January to June 2023 among 317 females aged 15 to 49 years in an urban resettlement area of Gautam Buddh Nagar district in Uttar Pradesh. Statistical analysis used included descriptive statistics and Chi-square test. SPSS 23 was used for data analysis. Results: There was a prevalence of 65.3% of at least one self-reported symptom suggestive of RTI/STI or gynaecological morbidity among the respondents. Among the symptomatic respondents, 54.1% were found to seek treatment. Among the reasons given for not seeking treatment in any health facility, the majority (83.1%) responded 'lack of awareness that the problem needed medical treatment' and 'stigma related with the problem' to be the main reasons. Conclusion: The reproductive healthcare seeking behaviour was found to be inadequate, with only 54.1% of symptomatic respondents seeking treatment. Enhanced health awareness sessions can be planned in the short term, and skilled communicators within or outside of the health system in the long term may be deployed to disseminate information in the community regarding sexual and gynaecological morbidities in reproductive age group women and their timely intervention.

5.
Clin Cosmet Investig Dermatol ; 17: 863-875, 2024.
Article in English | MEDLINE | ID: mdl-38651075

ABSTRACT

Purpose: A double-blind, placebo-controlled, randomized, proof-of-concept trial aimed to evaluate the efficacy and safety of VerbasnolTM [Rehmannia glutinosa Libosch leaf-based extract (RGLE)] in females, with moderate to severe acne vulgaris. Participants and Methods: Twenty-two females aged 18 to 35 years having moderate to severe acne with Global Acne Grading System (GAGS) scores of 19 to 38 were included in the study and were randomized in a 1:1 ratio to receive either one capsule (100 mg/day) of RGLE or placebo orally after breakfast for 56 days. The primary outcome was a change in acne severity measured by the GAGS compared to the placebo on day 56. The secondary outcomes were changes in the number of inflammatory acne lesions, facial sebum secretion, quality of life, local pain and itching, skin wrinkle severity, and other skin characteristics, including radiance, luminosity, smoothness, texture, firmness, and hydration. Additionally, the percentage of responders and global tolerability and efficacy were evaluated. Results: The mean GAGS score was reduced by 21.72% and 14.20% on day 28 in RGLE (n=10) and placebo groups (n=12), respectively, which further reduced in both groups on day 56. The RGLE group reported better improvement in other skin characteristics on day 56. No safety or tolerability concerns were reported for the extract. RGLE reduced acne and improved the skin quality in females compared to placebo as early as 28 days of supplementation. Conclusion: RGLE supplementation at a dose of 100 mg/day has provided a clinically relevant decrease in acne severity and improved the skin hydration and quality of life of the participants with acne after 56 days of dose administration.

6.
Sci Rep ; 14(1): 3317, 2024 02 09.
Article in English | MEDLINE | ID: mdl-38336815

ABSTRACT

Bacterial vaginosis (BV) can cause vaginal dysbiosis that may influence general vaginal health and pregnancy complications. Balancing vaginal microbiome using Lactobacillus spp. may be a new way to prevent and treat mild BV. We conducted a randomized, double-blind, placebo-controlled pilot study aimed at evaluating the effect of the product VagiBIOM, a multi-Lactobacillus vaginal suppository, on peri- and premenopausal women with BV in restoring vaginal pH and overall vaginal health by resetting the vaginal microbiome composition. Sixty-six peri- and premenopausal women with BV symptoms were randomized with a 2:1 ratio to be treated with VagiBIOM or placebo suppositories. Vaginal pH, VAS itching score, total Nugent score, and vaginal health index (VHI) were measured. Vaginal microbiome changes before and after the treatment were analyzed by 16S rRNA sequencing and bioinformatics analysis. After 4 weeks of intervention with VagiBIOM or a placebo, the mean score for vaginal pH, VAS itching, and total Nugent score was significantly decreased from the baseline. Compared to the baseline scores, the VHI scores improved significantly following 28-day intervention (p < 0.001). Our results revealed two Lactobacillus species, L. hamsteri, and L. helveticus, as indicator species occurring differentially in the VagiBIOM-treated group. Furthermore, the regression and species network analyses revealed significant bacterial associations after VagiBIOM treatment. Lactobacillus hamsteri was positively associated with the Nugent score and negatively associated with vaginal pH. L. iners and L. salivarius were positively and inversely associated with VHI. As is typical, Bacteroides fragilis was positively associated with vaginal pH and negatively associated with the Nugent score. Interestingly, the Lactobacillus spp. diversity improved after VagiBIOM treatment. The VagiBIOM suppository treatment for peri- and premenopausal women with BV significantly relieved vaginal itching by decreasing vaginal pH and Nugent scores and improving the overall VHI after 4 weeks' intervention. This effect was primarily the result of VagiBIOM improving vaginal Lactobacillus diversity.Trial Registration ClinicalTrials.gov registration: NCT05060029, first registration 09/28/2021: Title: A Pilot Study to Evaluate the Efficacy and Safety of Lactobacillus Species Suppositories on Vaginal Health and pH.


Subject(s)
Vaginosis, Bacterial , Pregnancy , Female , Humans , Vaginosis, Bacterial/drug therapy , Vaginosis, Bacterial/diagnosis , Suppositories , RNA, Ribosomal, 16S/genetics , Pilot Projects , Perimenopause , Vagina/microbiology , Lactobacillus/genetics , Pruritus
7.
J Back Musculoskelet Rehabil ; 37(2): 487-502, 2024.
Article in English | MEDLINE | ID: mdl-38073372

ABSTRACT

BACKGROUND: Low back pain (LBP) has emerged as a major public health concern leading to significant work productivity loss and deterioration in the quality of life. OBJECTIVE: A randomized, double-blind, placebo-controlled parallel-group clinical trial was conducted to investigate the effect of E-PR-01, a proprietary blend of Vitex negundo leaves and zingiber officinale rhizome, in individuals with LBP. METHODS: Seventy-two individuals aged 18 to 60 years with LBP were randomized in a 1:1 ratio in either the E-PR-01 or placebo group. The participants were instructed to take 2 capsules/day of the study products in two divided doses for 30 days. The study outcomes were changes in functional activity, bending flexibility, pain intensity, work productivity, and sleep quality. The sustained effect of the study products was also evaluated on the pain and physical functioning for 7 days after stopping the product intake. The product's safety was evaluated by adverse events reporting throughout the study. RESULTS: Compared to the placebo, the E-PR-01 demonstrated a statistically significant reduction in functional disability (mean RMQ score: -5.47 vs. -2.48), pain intensity (mean VAS score: -31.29 vs. -14.55) and improved bending flexibility (mean distance: -5.60 vs. -2.38 cm). In addition, a significant improvement in work productivity as well as sleep quality was also observed. In the E-PR-01 group, a statistically significant sustained effect was observed compared to the placebo for the pain intensity (p< 0.0005) and the functional activity (p< 0.0001) scores. No significant adverse event was reported in the study. CONCLUSION: E-PR-01 significantly improved low back pain and bending flexibility in adults without adverse effects. Moreover, the effect of E-PR-01 lasted 7 days after stopping the intervention.


Subject(s)
Low Back Pain , Monosaccharides , Steroids , Adult , Humans , Low Back Pain/drug therapy , Quality of Life , Pain Measurement , Physical Therapy Modalities , Double-Blind Method , Treatment Outcome
8.
Biochem Biophys Res Commun ; 680: 108-118, 2023 Nov 05.
Article in English | MEDLINE | ID: mdl-37738900

ABSTRACT

The consecutive launch of mRNA vaccines like mRNA-1273, BNT 162b2, and GEMCOVAC®-19 against COVID-19 has triggered the debate of long-term expression, safety, and genomic integration of the mRNA vaccine platforms. In the present study, we examined the longevity of antigenic protein expression of mRNA-614 and mRNA-S1LC based on self-amplifying mRNA (SAM) in Expi-293F™, HEK-293 T, and ARPE-19 cells. The protein expression was checked by sandwich-ELISA, FACS, luciferase activity assay, and Western blot. The transcribed antigenic mRNA was sequenced and found to be un-mutated. Additionally, no genomic integration of the reverse transcribed mRNA was observed even up to 7 days post-transfection as verified by PCR. Furthermore, we have generated high-quality 3D structures of non-structural proteins (nsPs) in silico and the genes encoding for the nsPs were cloned and expressed using the T7 system. Findings from the current study have strengthened the fact that the alphavirus-based SAM platform has the potential to become a modality in the upcoming years.

9.
World J Gastroenterol ; 29(28): 4451-4465, 2023 Jul 28.
Article in English | MEDLINE | ID: mdl-37576702

ABSTRACT

BACKGROUND: Probiotics have shown promise in alleviating symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D); however, the certainty of evidence is low. Well-powered randomized controlled dose-ranging trials are warranted on promising single-strain candidates. AIM: To investigate the clinical efficacy of Lactiplantibacillus plantarum (L. plantarum) Lpla33 (DSM34428) in adults with IBS-D. METHODS: This is a randomized, double-blind, placebo-controlled, multi-center, and dose-ranging study. Three hundred and seven adults, 18-70 years of age, with IBS-D, according to Rome IV criteria, were allocated (1:1:1) to receive placebo or L. plantarum Lpla33 at 1 × 109 (1B) or 1 × 1010 (10B) colony-forming units/d over an 8-wk intervention period. The primary outcome was the change in IBS severity scoring system (IBS-SSS) total score after 8 wk, while secondary and exploratory outcomes included abdominal pain severity, IBS related quality of life, stool and microbial profile, and perceived stress. RESULTS: IBS-SSS was significantly reduced, after 8 wk, in participants receiving L. plantarum 1B (-128.45 ± 83.30; P < 0.001) and L. plantarum 10B (-156.77 ± 99.06; P < 0.001), compared to placebo (-58.82 ± 74.75). Further, a dose-ranging effect was observed, with a greater absolute reduction in the L. plantarum 10B group (P < 0.05). A reduction in sub-scores related to abdominal pain, abdominal distension, bowel habits, and quality of life was observed in both L. plantarum groups compared to placebo (P < 0.001). Further, 62.5% and 88.4% of participants administered L. plantarum 1B and 10B, respectively, were classified as stool consistency responders based on a reduction in diarrheal stool form, as compared to 26.3% in the placebo group (P < 0.001). In contrast, no significant shifts were observed in microbial diversity. CONCLUSION: L. plantarum Lpla33 (DSM34428) is well tolerated and improves IBS symptom severity with a dose-ranging effect and a corresponding normalization of bowel habits in adults with IBS-D.


Subject(s)
Irritable Bowel Syndrome , Adult , Humans , Irritable Bowel Syndrome/complications , Irritable Bowel Syndrome/drug therapy , Quality of Life , Diarrhea/etiology , Diarrhea/complications , Treatment Outcome , Abdominal Pain/diagnosis , Abdominal Pain/drug therapy , Abdominal Pain/etiology , Double-Blind Method
10.
Obesity (Silver Spring) ; 31(8): 2009-2020, 2023 08.
Article in English | MEDLINE | ID: mdl-37424169

ABSTRACT

OBJECTIVE: The study aimed to investigate the effect of synbiotics on body composition and metabolic health in individuals with excessive body weight. METHODS: The 12-week randomized, double-blind, placebo-controlled clinical trial had individuals aged 30 to 60 years with BMI of 25 to 34.9 kg/m2 . In total, 172 participants were randomly allocated to either synbiotic V5 or V7 groups or the placebo group. The primary outcome was change in BMI and body fat percentage. Secondary outcomes were changes in weight, other metabolic health and inflammatory markers, gastrointestinal quality of life, and eating behaviors. RESULTS: The V5 and V7 groups had a significant reduction in BMI (p < 0.0001) from baseline to the end of the study, as opposed to the nonsignificant change in the placebo group (p = 0.0711). This reduction in the V5 and V7 groups was statistically significant when compared individually with the change in the placebo group (p < 0.0001). This corresponded well with the decrease in body weight with V5 and V7 (p < 0.0001). In addition, compared with placebo, the increase in high-density lipoprotein was statistically significant in the V5 (p < 0.0001) and V7 groups (p = 0.0205). A similar trend was observed in the high-sensitivity C-reactive protein levels, with a statistically significant decrease in the V5 (p < 0.0001) and V7 (0.0005) groups. CONCLUSIONS: The study demonstrates that synbiotic V5 and V7 were effective in reducing body weight in individuals with lifestyle modification.


Subject(s)
Overweight , Synbiotics , Humans , Adult , Overweight/therapy , Overweight/metabolism , Quality of Life , Biomarkers , Obesity/therapy , Double-Blind Method , Weight Loss
11.
J Pain Res ; 16: 2141-2153, 2023.
Article in English | MEDLINE | ID: mdl-37384126

ABSTRACT

Purpose: A randomized, double-blind, placebo-controlled cross-over study was conducted to investigate the efficacy and safety of E-PR-01, a proprietary formula containing Vitex negundo and Zingiber officinale, on knee joint discomfort due to pain. Patients and Methods: Forty adults aged 20-60 years with self-reported pain score of ≤30 mm at rest and ≥60 mm post-exertion on a 100-mm visual analog scale (VAS) were randomized in a 1:1 ratio to receive either the E-PR-01 (200 mg twice daily) or placebo for 5 days. The primary outcome was time to achieve meaningful pain relief (MPR) (≥40% reduction in post-exertion pain VAS score from baseline) post-single dose of intervention on day 1 compared to placebo. The secondary outcomes were post-exertion pain intensity difference (PID) at 2-, 3- and 4-hours and time-weighted sum of pain intensity difference (SPID) over 4 hours post single dose on day 1; post-exertion VAS score at 4 hours' post-intervention on day 5; percentage of responders on day 1; and physical efficiency as assessed by the total duration of exercise sessions completed after single dose of IP compared to placebo. Results: The average time to achieve MPR was 3.38 hours, 32.50% of participants achieved it in the E-PR-01 group post single-dose administration on day 1 as opposed to the placebo where no participant achieved MPR. There were significant intergroup differences in PID (-23.58 vs 2.45 mm) and SPID (-67.48 vs -0.08 mm) at 4 hours of E-PR-01 and placebo administration on day 1. 95% of participants in the IP group experienced some degree of pain relief within 2 hours compared to 37.5% in the placebo group. Conclusion: A single dose of E-PR-01 provided a statistically significant as well as clinically meaningful reduction in exercise-induced knee joint discomfort within 4 hours of administration.

12.
J Family Med Prim Care ; 12(2): 360-365, 2023 Feb.
Article in English | MEDLINE | ID: mdl-37091023

ABSTRACT

Objective: The English version of the Summary of Diabetes Self-Care Activities (SDSCA) measure is the most often used self-reporting instrument assessing diabetes self-management. This study was aimed at translating English SDSCA into the Hindi version and validating and evaluating its psychometric properties. Methods: The Hindi version of SDSCA was developed based on the guidelines provided by the World Health Organization (2008) for translation and adaptation of tool. Following steps were adopted: (1) Cultural and linguistic validation, (2) content validity testing, (3) construct validity testing, and (4) internal validity testing. Sixty women diagnosed with GDM were selected for the purpose of this study. Results: The tool showed promising and satisfactory results. Of mention are the results related to Cronbach's alpha (0.82). The exploratory factor analysis showed three factors that fit the data satisfactorily. Conclusions: This study provided evidence for the reliability and validity of the Hindi Summary of Diabetes Self-Care Activities instrument, which may be used in the future to assess diabetes self-management activities among the pregnant women diagnosed with gestational diabetes mellitus among Hindi-speaking population.

13.
J Pain Res ; 16: 1115-1126, 2023.
Article in English | MEDLINE | ID: mdl-37020664

ABSTRACT

Background: The primary objective of the present study was to evaluate the effects of a Nerve Support Formula NeuropAWAY® on diabetic neuropathic pain. Methods: This double-blind, placebo-controlled, randomized trial was conducted between August 2020 and February 2021. Patients aged ≥40 and ≤65 years with a history of type 2 diabetes (T2D) with a confirmed diagnosis of diabetic neuropathic pain were included in the study. The primary efficacy endpoint was to assess the effect of the 42 days administration of the Nerve Support Formula on the neuropathic pain as assessed by the 11 point Pain Intensity Numeric Rating Scale (PI-NRS). The secondary objectives were to assess the effect on plasma vitamin B12 levels, nerve conduction velocity, blood flow velocity, Brief Pain Inventory, Neuropathy Total Symptom Score, and Insomnia Severity Index. Results: The enrolled study population (n=59) was randomized in two study groups; the Investigational Product (IP) group - Nerve Support Formula (n=27) and placebo group (n=32). The mean age of these participants was 52.63 and 53.72 for IP and placebo group, respectively. The mean (SD) HbA1c levels for IP and placebo group were 8.37 (0.85) and 8.16 (0.86), respectively. By the end of the study (Day 42) the decrease in PI-NRS scores for the IP group was maximal (↓61.32%) and highly significant (p<0.001) in comparison to the placebo group (↑2.47%). Significant improvements (p<0.05) were also noted in the secondary efficacy variables after 42 days of IP intake. Conclusion: The formula was found to be significantly effective as compared to placebo in reducing pain and other sensory symptoms related to the diabetic peripheral neuropathy.

14.
Tour Manag Perspect ; 46: 101095, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36937090

ABSTRACT

COVID-19 has negatively affected the travel and tourism industry and may continue to do so in the future. Therefore, hospitality businesses need to pay attention to consumer reactions, concerns, and motives for travelling in this era. This study leverages the stimulus-organism-behaviour-consequence (SOBC) model to examine psychological factors that influence Japanese travellers' intention to travel and willingness to pay premiums for safe travel by analysing data from 790 respondents. The findings of the study reveal that extraversion positively associates with introjected motivation and negatively with amotivation. Neuroticism personality type positively associates with amotivation and negatively associates with introjected motivation. Introjected motivation positively associates with perception of safe travel during COVID-19, whereas amotivation has a non-significant association with perception of safe travel during COVID-19. Perception of safe travel positively associates with intention to travel and willingness to pay premiums for safe travel. Finally, intention to travel has no effect on willingness to pay premiums for safe travel. These findings provide valuable theoretical and managerial implications.

15.
Environ Sci Pollut Res Int ; 30(44): 98747-98759, 2023 Sep.
Article in English | MEDLINE | ID: mdl-36656480

ABSTRACT

The power conversion efficiency of all-inorganic Sb2S3-on-Si two-terminal (2-T) monolithically integrated and four-terminal (4-T) mechanically stacked tandem solar cells are investigated. A one-dimensional solar cell capacitance simulator (SCAPS-1D) has been used to simulate the stand-alone antimony trisulfide (Sb2S3) top sub-cell, silicon (Si) bottom sub-cell, 2-T monolithic, and 4-T mechanically stacked tandem solar cells. The stand-alone sub-cells are optimized by extensive studies, including interface defects density, bulk defects density, absorber layer thickness, and series resistance. The power conversion efficiency (PCE) of simulated stand-alone sub-cells is compared and verified with the existing literature. A current matching condition is established to characterize the 2-T monolithic Sb2S3-on-Si tandem cell. A filtered spectrum has been utilized for bottom sub-cell measurement in the tandem solar cells. The best-simulated PCE of Sb2S3-on-Si 2-T monolithic and 4-T tandem cells is 30.22% and 29.30%, respectively. The simulation results presented in this paper open an opportunity for the scientific community to consider Sb2S3 as a potential top sub-cell material in Sb2S3-on-Si tandem solar cells with high PCE.


Subject(s)
Models, Theoretical , Silicon , Computer Simulation , Electric Capacitance
16.
J Exp Orthop ; 9(1): 123, 2022 Dec 23.
Article in English | MEDLINE | ID: mdl-36562843

ABSTRACT

PURPOSE: Knee osteoarthritis (OA) is the most common form of clinical arthritis in middle-aged and older individuals. Undenatured or native type II (TII) collagen derived from the chicken sternum has a good therapeutic effect on relieving severe pain of OA. Hence, the present study aimed to investigate the efficacy and safety of TII collagen (Native CT-II®) in individuals with knee OA. METHODS: We conducted a 12-week randomised, double-blind, placebo-controlled, parallel-group study on 101 participants aged 40-65 years with knee OA. The participants were randomised to receive either TII collagen, glucosamine hydrochloride + chondroitin sulfate (G + C) or a placebo. The primary outcome was an improvement in the joint health of the participants assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) compared to G + C and placebo. RESULTS: Compared with the placebo group (n = 27), the TII collagen group (n = 29) and G + C group (n = 29) significantly improved the overall joint health measured by the change in WOMAC total score (week 12: TII collagen = -32.47 ± 19.51 and G + C = -33.74 ± 24.64 vs. placebo = -13.84 ± 17.61; p < 0.05) and relieved knee joint pain (week 12: TII collagen = -5.69 ± 3.66 and G + C = -6.03 ± 4.72 vs. placebo = -2.71 ± 3.95; p < 0.05). The statistically significant effect was observed as early as 4 weeks after the investigational product administration. Additionally, the TII collagen was more effective in improving the quality of life than the G + C. CONCLUSION: TII collagen not only has a significantly better effect and high safety profile for OA but also improves the quality of life of patients. LEVEL OF EVIDENCE: Level 1 - Randomized Controlled Trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04470336 ; First submitted date: July 08, 2020; First posted date: July 14, 2020.

17.
J Multidiscip Healthc ; 15: 2511-2525, 2022.
Article in English | MEDLINE | ID: mdl-36349244

ABSTRACT

Purpose: E-OJ-01 (OxyjunTM), a proprietary, standardized aqueous extract of Terminalia arjuna (TA) bark, has previously shown promising cardiovascular health benefits in healthy young athletic adults and is now being tested to determine its ability to support left ventricular ejection fraction and associated parameters in a diverse population. Participants and Methods: Healthy adults aged 30-70 years (n=72) were included in the study to investigate the effect of 400 mg/day of E-OJ-01 when administered for 8 weeks on myocardial pumping capacity, primarily left ventricular ejection fraction (LVEF). The secondary endpoints were improvement in diastolic filling (E/A) ratio, rate pressure product (RPP), and fatigue severity scale (FSS) score. The effect of the intervention on blood lipids and gamma-glutamyltransferase (GGT) levels was also explored. The safety of the intervention was evaluated by monitoring adverse events, vitals (heart rate (HR), blood pressure (BP), and body temperature (BT)), and liver (serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT)) and kidney function (serum creatinine). Results: E-OJ-01 increased the LVEF by 6.28% (percentage change) from the baseline compared with 0.24% (percentage change) in the placebo group (p<0.05). It reduced fatigue (22.52%), RPP (1.54%), and GGT levels (5.90%) from the baseline. No adverse events related to the intervention were observed during the study. Conclusion: The study showed that E-OJ-01 could improve cardiac pumping capacity by significantly increasing LVEF and reducing fatigue in a diverse, healthy population.

18.
J Family Med Prim Care ; 11(7): 3559-3564, 2022 Jul.
Article in English | MEDLINE | ID: mdl-36387735

ABSTRACT

Context: Tobacco use is the leading single preventable cause of deaths worldwide. India is the second largest consumer of tobacco in the world. Aims: To study the prevalence of tobacco use among the adult population >15 years age of District Gautam-Budh Nagar and find the association of various socio-demographic factors with the tobacco usage. Settings and Design: Cross-sectional community-based study conducted in urban and rural areas of District Gautam-Budh Nagar, Uttar-Pradesh. Subjects and Methods: The study was conducted among 1461 adults aged 15 years and above in the District Gautam-Budh Nagar. Multistage sampling was used to select the study subjects. The questionnaire used for the interview consisted of questions related to socio-demographic profile, smoking habits and smokeless tobacco use, intention to quit and exposure to second-hand smoke. Statistical Analysis: The data were entered and analyzed in SPSS Software version 20.0. The prevalence of tobacco use was expressed in percentages. The association between various socio-demographic factors and tobacco use was assessed by Chi-square test. P value < 0.05 was taken as significant. Results: Prevalence of tobacco usage in this study was found to be 50.4% (65% among males and 28.8% among females). The prevalence of smoking and smokeless tobacco use in our study was 37.2% and 21.3%, respectively. Increasing age, male gender, and lower educational status were found to be significant risk factors for tobacco use in our study. Conclusions: India needs to gear up the efforts more and can still do more to make the proven tobacco control tools work for its citizens' well-being.

19.
Clin Cosmet Investig Dermatol ; 15: 2051-2064, 2022.
Article in English | MEDLINE | ID: mdl-36199383

ABSTRACT

Background: The skin is primarily affected by aging, especially when it is exposed to particulate matter present in the environment. It has been hypothesized that consumption of products with known antioxidant properties would help combat factors associated with both intrinsic and extrinsic aging factors. Objective: The aim of the present study was to evaluate the effect of the formulation Blue Fenugreek Kale Extract (BFKE) on skin aging. Methods: In this study, the effect of BFKE on protein oxidation was determined in human dermal fibroblasts by analysis of the level of protein carbonylation after cells were stressed with either H2O2 or urban pollution consisting of particulate matter and UV-A. Furthermore, a randomized, double-blind, placebo-controlled clinical study that evaluated the effect of BFKE consumption over a period of 56 days in 59 volunteers was performed. The major parameter studied was skin barrier dysfunction through the assessment of Transepidermal Water Loss (TEWL). Additional parameters analyzed clinically include skin moisture content, participant self-assessment of skin parameters, wrinkle severity, skin sagging and elasticity. Furthermore, low grade and allergic inflammatory biomarker levels were measured at the start and end of the treatment period, along with oxidative stress assessment using blood malondialdehyde levels. Results: BFKE significantly reduced protein carbonylation in human dermal fibroblasts stressed with urban pollution. In the clinical study, the TEWL level reduced significantly and at the same time the skin moisture content levels increased by end of the treatment period. No significant changes were observed in wrinkle severity, skin sagging, elasticity, inflammatory and oxidative stress biomarker levels. Participant and investigator perception of treatment was significantly greater after product consumption, as was the improvement in skin parameters based on participant self-assessment. Conclusion: BFKE reduces protein oxidation induced by H2O2 and restores skin barrier function and skin hydration, while also combating early signs of aging.

20.
Molecules ; 27(20)2022 Oct 18.
Article in English | MEDLINE | ID: mdl-36296585

ABSTRACT

Multi-drug resistance is increasing in the pathogenic bacterium S. pneumoniae, which is mainly responsible for meningitis and community-acquired pneumonia (CAP), highlighting the need for new anti-pneumococcal agents. We have identified a potential anti-pneumococcal agent, enol 3, which acts by hindering the cell division process by perturbing Z-ring dynamics inside the cell. Enol 3 was also shown to inhibit FtsZ polymerization and induce its aggregation in vitro but does not affect the activity of tubulin and alkaline phosphatase. Docking studies show that 3 binds near the T7 loop, which is the catalytic site of FtsZ. Similar effects on Z-ring and FtsZ assembly were observed in B. subtilis, indicating that 3 could be a broad-spectrum anti-bacterial agent useful in targeting Gram-positive bacteria. In conclusion, compound 3 shows strong anti-pneumococcal activity, prompting further pre-clinical studies to explore its potential.


Subject(s)
Bacterial Proteins , Cytoskeletal Proteins , Cytoskeletal Proteins/metabolism , Bacterial Proteins/metabolism , Tubulin/metabolism , Alkaline Phosphatase/metabolism , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/metabolism , Bacillus subtilis
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