A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy of a Nerve Support Formula on Neuropathic Pain in Individuals Suffering from Type II Diabetes Mellitus.

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.

An exploratory double-blind, randomized, placebo-controlled study to assess the efficacy of CitruSlim on body composition and lipid parameters in obese individuals.

The prevalence of obesity in developing and developed countries has been well recognized, and the worldwide obesity rates have nearly tripled since 1975, according to the World Health Organization. CitruSlim, a standardized product containing a blend of Citrus bergamia and Eurycoma longifolia, can reduce cortisol, cholesterol, triglycerides, and hyperglycemia. These properties can contribute to reduction in body weight or body mass index (BMI) in obese patients. A randomized, double-blind, placebo-controlled clinical study was designed to evaluate the efficacy and tolerability of CitruSlim in body weight management in obese individuals, and the results were compared with that of placebo. A total of 97 participants were allocated, randomized, and treated with CitruSlim high-dose (HD, 400 mg), CitruSlim low-dose (LD, 200 mg), and placebo for 112 days. At the end of the study, CitruSlim HD and CitruSlim LD significantly reduced BMI compared to the placebo group and were well tolerated; however, it did not improve parameters associated with dyslipidemia and metabolic disturbances. The study findings suggested that CitruSlim was effective in reducing body weight in obese patients.

Effect of Alpinia galanga on Mental Alertness and Sustained Attention With or Without Caffeine: A Randomized Placebo-Controlled Study.

OBJECTIVE: Although Alpinia galanga has been reported to improve cognitive performance in animals, it has not been thoroughly studied for its potential psychostimulant effect in humans. A randomized, double-dummy, double-blind, placebo-controlled cross-over study was conducted to determine the effect of A galanga on mental alertness and sustained attention in comparison with caffeine and placebo in participants with a habitual caffeine intake. METHODS: Fifty-nine participants (18-40 years and body mass index of ≥18.5 and <25.00 kg/m2) with moderate caffeine consumption were enrolled. The participants had a Generalized Anxiety Disorder-7 score ≤7, Patient Health Questionnaire-9 score ≤14 and a Jin Fan's Attention Network Test alertness score of 50 ± 20 ms. The interventional product (placebo, A galanga proprietary extract [E-AG-01], caffeine, and a combination of E-AG-01 with caffeine) was administered to the participants, followed by sequential administration of the remaining interventions on the consecutive study visits; the effects on mental alertness, sustained attention, and sleep architecture, along with safety and tolerability, were analyzed by validated methods. RESULTS: In the E-AG-01 group, the alertness score was increased by 11.65 ± 23.94, 12.50 ± 19.73, and 12.62 ± 0.68 ms from baseline at 1, 3 (p = 0.042), and 5 hours, respectively, indicating its efficacy to enhance mental alertness and the increase in alertness score as compared to placebo. In the composite group (E-AG-01 with caffeine), mean response time was significantly reduced, by 15.55 ms (p = 0.026) at 3 hours. CONCLUSIONS: A galanga (E-AG-01) induces a beneficial effect in mental alertness and the combination of A galanga with caffeine impedes the caffeine crash and improves sustained attention at 3 hours. Thus, these stimulant effects might yield a new usage for A galanga as a key ingredient in energy drinks or similar products.

Effect of E-OJ-01 on Cardiac Conditioning in Young Exercising Adults: A Randomized Controlled Trial.

BACKGROUND AND AIM: Cardiac health is a determinant of athletic performance. A body of data suggests that in healthy young adults, an increase in maximal cardiac output leads to an increase in endurance. Terminalia arjuna (TA) has been studied for multiple benefits in cardiovascular health although its effects as a cardioprotective ergogenic aid require further exploration. The current trial was planned to study the effect of the proprietary TA extract (E-OJ-01) on the markers of cardiac conditioning in healthy young adults. STUDY QUESTION: No study has assessed the effect of TA extract on cardiac conditioning by improvement of left ventricular ejection fraction (LVEF) in young exercising individuals. STUDY DESIGN, MEASURES AND OUTCOMES: A randomized, double-blind, placebo-controlled, parallel group study was conducted to determine the efficacy and safety of E-OJ-01 for use as an ergogenic supplements in young exercising adults. This trial was registered at ClinicalTrials.gov (NCT02207101) and reported according to Consolidated Standards of Reporting Trials (CONSORT) requirements. Thirty-two healthy males, aged 18-40 years performing regular endurance exercise, were randomly assigned to 400 mg of E-OJ-01 or placebo for 56 days. LVEF, right and left ventricular Myocardial Performance Index, and Borg Rated Perceived Exertion (RPE) were assessed at baseline, day 28, and day 56; creatine kinase-MB and troponin-T were assessed at baseline and at day 56. RESULTS: As compared with placebo, 56 days of E-OJ-01 supplementation significantly improved the LVEF (P = 0.0001) and decreased the right ventricular Myocardial Performance Index (P = 0.001). The fatigue level captured by Borg Scale after completion of exercise showed a greater decrease in the E-OJ-01 group as compared with placebo. Creatine kinase-MB and troponin-T did not change significantly. CONCLUSIONS: TA (E-OJ-01) significantly increased cardiovascular efficiency and improved the cardiac conditioning in young healthy adults.

A clinical trial comparing Lanconone® with ibuprofen for rapid relief in acute joint pain.

BACKGROUND: To study the effect of Lanconone® (1000 mg) on acute pain on exertion as compared to the standard of care, Ibuprofen (400 mg). METHOD: The study recruited 72 subjects diagnosed with mild to moderate knee joint pain on exertion. Subjects with Pain Visual Analogue Scale of more than 40 mm were included. Uphill walking was provided as the stressor using Naughton's protocol on a treadmill. The subjects walked for 10 minutes continuously followed by a rest period and baseline pain score for index knee joint was recorded. Subjects were administered a single dose of Lanconone® (1000 mg)/Ibuprofen (400 mg). Thereafter the same stressor was provided at 0.5, 1, 2, 3, 4, and 6 hours, subsequently, pain scores were recorded on a visual analogue scale. Double stopwatch method was used to evaluate the onset of pain relief and time taken to meaningful pain relief. RESULT: Both Lanconone® and Ibuprofen showed the first perceived pain relief at 65.31 ± 35.57 mins as compared to 60.82 ± 32.56 mins respectively. The mean time taken to experience meaningful pain relief in Lanconone® group was 196.59 ± 70.85 mins compared to 167.13 ± 71.41 mins amongst Ibuprofen group. The meaningful pain relief continued for 6 hours. CONCLUSION: The current study successfully demonstrated rapid pain-relieving potential of Lanconone® which was comparable to Ibuprofen. No adverse event related to the interventions was reported in the study. TRIAL REGISTRATION: Clinical trials.gov NCT02417506 . 21 January 2015.

BDP-30, a systemic resistance inducer from Boerhaavia diffusa L., suppresses TMV infection, and displays homology with ribosome-inactivating proteins.

Root extract of Boerhaavia diffusa L. induced systemic resistance in tobacco against Tobacco mosaic virus. A 30 kDa protein was isolated as the active component, called BDP-30 on the basis of the molecular weight and source plant. BDP-30, a glycoprotein, was found to be temperature and protease resistant. It was basic, possessing a pI greater than 9.0. In-gel proteolytic digestion of BDP-30 generated two peptides that possessed the amino acid sequence KLYDIPPLR and KVTLPYSGNYER by LC/MS/MS. Both peptides shared absolute sequence identity with trichosanthin, a ribosome-inactivating protein from Trichosanthes kirilowii, and a 78 percent and 100 percent homology respectively with an RIP from Bryonia dioica, bryodin. Further, effort was made to look at the fate of TMV in induced resistant Nicotiana tabacum cv. Xanthi, a systemic host of the virus, at specified days after inoculation in control and treated plants. TMV coat protein (CP) was detected by immunoblot 7 days post inoculation up to 21 days in the control set, but not in treated resistant plants. TMV RNA was detected by RT-PCR using TMV-CP specific primers. Resistant tobacco did not show presence of TMV RNA up to 21 days of inoculation. This suggests that BDP-30 may be suppressing TMV replication.

A virus inhibitory protein isolated from Cyamopsis tetragonoloba (L.) Taub. upon induction of systemic antiviral resistance shares partial amino acid sequence homology with a lectin.

KEY MESSAGE: Two virus inhibitory proteins were purified from Cyamopsis tetragonoloba , induced to resist virus infections by CIP-29, a systemic resistance inducing protein from Clerodendrum inerme, and characterized. One of them shared homology with a lectin. CIP-29, a known 29 kDa systemic antiviral resistance inducing protein isolated from Clerodendrum inerme, has been used to induce systemic resistance in Cyamopsis tetragonoloba against Sunn-hemp rosette virus (SRV). Paper reports the detection of virus inhibitory activity in induced-resistant leaf sap of C. tetragonoloba, and the purification of two virus inhibitory agents (VIAs) thereof. VIA activity was recorded as a reduction in lesion number of SRV, Tobacco mosaic virus, and Papaya ringspot virus, when they were incubated separately with resistant sap and inoculated onto susceptible C. tetragonoloba, Nicotiana tabacum cv. Xanthi-nc, and Chenopodium quinoa, respectively. The two VIAs were isolated from resistant C. tetragonoloba plant leaves using combinations of column chromatography. Both were basic proteins, and since their M r was 32 and 62 kDa, these VIAs were called CT-VIA-32 and CT-VIA-62, respectively, on the basis of their molecular mass and the host. CT-VIA-62 displayed better activity, and was thus studied further. It tested positive for a glycoprotein, and was serologically detected only in leaf tissue post-induction. Tryptic peptides generated in-gel, post SDS-PAGE of CT-VIA-62, were sequenced through LC/MS/MS. All CT-VIA-62 peptides were found to share homologies with proteins from Medicago truncatula that possess a mannose-binding lectin domain.

Pharmacological potentials of Syzygium cumini: a review.

In the last few years there has been an exponential growth in the field of herbal medicine, and these drugs are gaining popularity in both developing and developed countries because of their natural origin and lesser side effects. Syzygium cumini (syn. Eugenia jambolana, Syzygium jambolana, Eugenia cumini, Syzygium jambos), commonly known as jamun in India, is an evergreen tree distributed throughout the Indian subcontinent, Southeast Asia and East Africa. It is mainly utilised as a fruit producer and for its timber. Medicinally, the fruit is reported to have antidiabetic, antihyperlipidaemic, antioxidant, antiulcer, hepatoprotective, antiallergic, antiarthritic, antimicrobial, anti-inflammatory, antifertility, antipyretic, antiplaque, radioprotective, neuropsychopharmacological, nephroprotective and antidiarrhoeal activities. Among these beneficial physiological effects, the antidiabetic property of S. cumini has the most promising nutraceutical value. The health-beneficial effects of S. cumini are mainly attributed to various phytoconstituents such as tannins, alkaloids, steroids, flavonoids, terpenoids, fatty acids, phenols, minerals, carbohydrates and vitamins present in the fruit. This review paper presents an overview of experimental evidence for the pharmacological potential of S. cumini.

Evaluation of inhibitory effect of the plant Phyllanthus amarus against dermatophytic fungi Microsporum gypseum.

OBJECTIVE: The antifungal activity of various solvent extracts (such as ether, chloroform, ethyl acetate and ethyl alcohol) of the plant Phyllanthus amarus against dermatophytic fungi Microsporum gypseum was observed. METHOD: Antifungal bioassay in terms of reduction in weight, colony diameter and sporulation of the target fungal colony was carried out using Broth Dilution method. Results Root part of the plant, extracted in various organic solvents did not show any noticeable antifungal activity. The percentage inhibition observed in different solvent extracts of aerial part was found as reduction in weight: chloroform [50.3%], ethyl acetate [27.7%] and ethyl alcohol [12.1%], reduction in colony diameter: chloroform [53.4%], ethyl acetate [31.4%] and ethyl alcohol [15.0%] and reduction in sporulation: maximum inhibition in chloroform extract, at test concentration of 4000 ppm at incubation period of 8 days. CONCLUSION: Chloroform fraction of the aerial part of the plant P. amarus shows significant inhibitory effect against dermatophytic fungi M. gypseum and requires chemical characterization for its bioactive principle.

Inhibitory effect of the plant Boerhavia diffusa l. against the dermatophytic fungus Microsporum fulvum.

Antifungal activity (reduction in colony diameter) of various extracts (pt. ether, chloroform, ethyl acetate, ethyl alcohol and aqueous) of aerial and root parts of Boerhavia diffusa (Nictaginaceae) was screened against dermatophytic fungi Microsporum fulvum. Statistically significant increase has been recorded in the % inhibition of the target fungal species with increasing test concentrations (1000-5000 ppm) of chloroform, ethyl acetate and ethyl alcohol extracts of the root. The maximum % inhibition observed in various solvent extracts of root was about 26% (chloroform), 46% (ethyl alcohol) and 57% (ethyl acetate) at 5000 ppm concentration with time exposure of 10 days. The colony diameter of the target mycelial colony decreased with increasing supplementation of the phytoextract, showing the presence of significant amount of some antifungal phytochemical moiety.

Insecticidal activity of the plant Phyllanthus amarus against Tribolium castaneum.

The plant Phyllanthus amarus is used as folk medicine since the year 1800 and has been established for its important medicinal properties particularly for liver ailments. The present communication explores the insecticidal activity of ethanolic extract of aerial and root parts of this plant against stored grain pest Tribolium castaneum. LC 50 values of ethanolic aerial part were 895.77, 473.91, 279.89 and 260.85 microg/cm2, while 512.62, 376.96, 248.88 and 209.79 microg/cm2 for ethanolic root part at the exposure of 3, 5, 7, 9 and 11 days respectively. Ethanolic root extract possessed significant insecticidal activity against T. castaneum.

Antifungal activity of Boerhavia diffusa against some dermatophytic species of Microsporum.

Various extracts petroleum ether, chloroform, ethyl acetate and ethyl alcohol) of aerial and root parts of Boerhavia diffusa was sereened for Antitungal activity (Inhibition in sporulation) against dermatophytic fungi Microsporum gypseum, M. fulvum and M. canis by using broth dilution method. Extracts of aerial part not show any noticeable antifungal activity. Ethyl acetate extract of root part of the plant was found to be most effective of against target fungal species. The maximum inhibition of mycelial growth was observed for M. gypseum (78.83%) followed by M. fulvum (62.33%) and M. canis (42.30%) of ethyl acetate in the test concentration of 1000 microg/ml 24 hours of incubation. The sporulation of target fungal species decreases with increasing supplementation of phytoextract, confirms the presence of some antifungal phytochemical moiety in roots of the plant.

Plant availability of cadmium in presence of organic acids: an interactive aspect.

The present communication reports the effect of various carboxylic and amino acids on the uptake and translocation of root-absorbed Cd by maize (Zea mays). Statistically significant increases in Cd accumulation in various plant tissues with increasing supplementation of organic acids suggested the existence of Cd-organic acid interaction in soil-rhizosphere environment of the plant. The potentiality of phytochelators (organic acids) to form plant available organically bound Cd is discussed.