Efficacy and classification of Sesamum indicum linn seeds with Rosa damascena mill oil in uncomplicated pelvic inflammatory disease using machine learning.

Background and objectives: As microbes are developing resistance to antibiotics, natural, botanical drugs or traditional herbal medicine are presently being studied with an eye of great curiosity and hope. Hence, complementary and alternative treatments for uncomplicated pelvic inflammatory disease (uPID) are explored for their efficacy. Therefore, this study determined the therapeutic efficacy and safety of Sesamum indicum Linn seeds with Rosa damascena Mill Oil in uPID with standard control. Additionally, we analyzed the data with machine learning. Materials and methods: We included 60 participants in a double-blind, double-dummy, randomized standard-controlled study. Participants in the Sesame and Rose oil group (SR group) (n = 30) received 14 days course of black sesame powder (5 gm) mixed with rose oil (10 mL) per vaginum at bedtime once daily plus placebo capsules orally. The standard group (SC), received doxycycline 100 mg twice and metronidazole 400 mg thrice orally plus placebo per vaginum for the same duration. The primary outcome was a clinical cure at post-intervention for visual analogue scale (VAS) for lower abdominal pain (LAP), and McCormack pain scale (McPS) for abdominal-pelvic tenderness. The secondary outcome included white blood cells (WBC) cells in the vaginal wet mount test, safety profile, and health-related quality of life assessed by SF-12. In addition, we used AdaBoost (AB), Naïve Bayes (NB), and Decision Tree (DT) classifiers in this study to analyze the experimental data. Results: The clinical cure for LAP and McPS in the SR vs SC group was 82.85% vs 81.48% and 83.85% vs 81.60% on Day 15 respectively. On Day 15, pus cells less than 10 in the SR vs SC group were 86.6% vs 76.6% respectively. No adverse effects were reported in both groups. The improvement in total SF-12 score on Day 30 for the SR vs SC group was 82.79% vs 80.04% respectively. In addition, our Naive Bayes classifier based on the leave-one-out model achieved the maximum accuracy (68.30%) for the classification of both groups of uPID. Conclusion: We concluded that the SR group is cost-effective, safer, and efficacious for curing uPID. Proposed alternative treatment (test drug) could be a substitute of standard drug used for Female genital tract infections.

Efficacy of a vaginal suppository formulation prepared with Acacia arabica (Lam.) Willd. gum and Cinnamomum camphora (L.) J. Presl. in heavy menstrual bleeding analyzed using a machine learning technique.

Objective: This study aims to determine the efficacy of the Acacia arabica (Lam.) Willd. and Cinnamomum camphora (L.) J. Presl. vaginal suppository in addressing heavy menstrual bleeding (HMB) and their impact on participants' health-related quality of life (HRQoL) analyzed using machine learning algorithms. Method: A total of 62 participants were enrolled in a double-dummy, single-center study. They were randomly assigned to either the suppository group (SG), receiving a formulation prepared with Acacia arabica gum (Gond Babul) and camphor from Cinnamomum camphora (Kafoor) through two vaginal suppositories (each weighing 3,500 mg) for 7 days at bedtime along with oral placebo capsules, or the tranexamic group (TG), receiving oral tranexamic acid (500 mg) twice a day for 5 days and two placebo vaginal suppositories during menstruation at bedtime for three consecutive menstrual cycles. The primary outcome was the pictorial blood loss assessment chart (PBLAC) for HMB, and secondary outcomes included hemoglobin level and SF-36 HRQoL questionnaire scores. Additionally, machine learning algorithms such as k-nearest neighbor (KNN), AdaBoost (AB), naive Bayes (NB), and random forest (RF) classifiers were employed for analysis. Results: In the SG and TG, the mean PBLAC score decreased from 635.322 ± 504.23 to 67.70 ± 22.37 and 512.93 ± 283.57 to 97.96 ± 39.25, respectively, at post-intervention (TF3), demonstrating a statistically significant difference (p < 0.001). A higher percentage of participants in the SG achieved normal menstrual blood loss compared to the TG (93.5% vs 74.2%). The SG showed a considerable improvement in total SF-36 scores (73.56%) compared to the TG (65.65%), with a statistically significant difference (p < 0.001). Additionally, no serious adverse events were reported in either group. Notably, machine learning algorithms, particularly AB and KNN, demonstrated the highest accuracy within cross-validation models for both primary and secondary outcomes. Conclusion: The A. arabica and C. camphora vaginal suppository is effective, cost-effective, and safe in controlling HMB. This botanical vaginal suppository provides a novel and innovative alternative to traditional interventions, demonstrating promise as an effective management approach for HMB.

Therapeutic Efficacy of a Formulation Prepared with Linum usitatissimum L., Plantago ovata Forssk., and Honey on Uncomplicated Pelvic Inflammatory Disease Analyzed with Machine Learning Techniques.

A single-blind double-dummy randomized study was conducted in diagnosed patients (n = 66) to compare the efficacy of Linseeds (Linum usitatissimum L.), Psyllium (Plantago ovata Forssk.), and honey in uncomplicated pelvic inflammatory disease (uPID) with standard drugs using experimental and computational analysis. The pessary group received placebo capsules orally twice daily plus a per vaginum cotton pessary of powder from linseeds and psyllium seeds, each weighing 3 gm, with honey (5 mL) at bedtime. The standard group received 100 mg of doxycycline twice daily and 400 mg of metronidazole TID orally plus a placebo cotton pessary per vaginum at bedtime for 14 days. The primary outcomes were clinical features of uPID (vaginal discharge, lower abdominal pain (LAP), low backache (LBA), and pelvic tenderness. The secondary outcomes included leucocytes (WBCs) in vaginal discharge on saline microscopy and the SF-12 health questionnaire. In addition, we also classified both (pessary and standard) groups using machine learning models such as Decision Tree (DT), Random Forest (RF), Logistic Regression (LR), and AdaBoost (AB). The pessary group showed a higher percentage reduction than the standard group in abnormal vaginal discharge (87.05% vs. 77.94%), Visual Analogue Scale (VAS)-LAP (80.57% vs. 77.09%), VAS-LBA (74.19% vs. 68.54%), McCormack pain scale (McPS) score for pelvic tenderness (75.39% vs. 67.81%), WBC count of vaginal discharge (87.09% vs. 83.41%) and improvement in SF-12 HRQoL score (94.25% vs. 86.81%). Additionally, our DT 5-fold model achieved the maximum accuracy (61.80%) in the classification. We propose that the pessary group is cost-effective, safer, and more effective as standard drugs for treating uPID and improving the HRQoL of women. Aucubin, Plantamajoside, Herbacetin, secoisolariciresinol diglucoside, Secoisolariciresinol Monoglucoside, and other various natural bioactive molecules of psyllium and linseeds have beneficial effects as they possess anti-inflammatory, antioxidant, antimicrobial, and immunomodulatory properties. The anticipated research work is be a better alternative treatment for genital infections.

Unani Therapy in Fourth-degree Uterovaginal Prolapse With Multiple Decubitus Ulcers: A Case Report.

Context: Pelvic organ prolapse (POP) is a leading health problem, in which pelvic organs-the uterus, bladder, and rectum-bulge from the vagina, causing bladder and bowel dysfunction. Uterovaginal prolapse (UVP), Nutu-al-Rahim, affects more than 50% of parous women (women who have had children), especially those above 60 years of age. Objective: The current case study intended to evaluate the benefits of a holistic Unani treatment in ameliorating POP symptoms, healing decubitus ulcers, preventing further prolapse, improving quality of life, and maintaining social independence. Design: The research team developed a case report. Setting: The study took place at the National Institute of Unani Medicine in Bengaluru, Karnataka, India. Participant: The participant was a 70 year-old female patient at the Institute with backache, spotting from the vagina, foul-smelling vaginal discharge, general weakness, and fourth-degree UVP with multiple decubitus ulcers. Intervention: The participant orally received Majun Moocharus, 7 g twice daily for 60 days,and took sitz baths (Abzan) once daily for 20 minutes for 60 days, which used a medicated decoction of 3g of alum (phitkari ) and 10 g each of a medicated decoction (Joshanda) of nutgalls from the Aleppo oak, Quercus infectoria (Mazu), root of lemon grass Andropogan jwarancusa (Izkhar), and pomegranate rind from Punica granatum (Post anar). She also used vaginal tampons (Hamul) which each used 2g of the same medicinal powder with 10 ml of rose oil and which was inserted into her vagina once per day for 60 days, in combination with pelvic-floor-muscle exercises. Results: The ulcers were healed within a week. The monthly follow-ups for ten months showed no cervical descent or symptoms associated with it. Conclusions: The current case study found that a fourth-grade UVP can be managed effectively with Unani medications. The participant's ulcers were healed, her clinical symptoms of UVP were reduced, and her quality of life improved. Clinical trials are recommended with large sample sizes to create a higher level of evidence for the efficacy of the Unani medicine.

A Systematic Review and Meta-Analysis of Premenstrual Syndrome with Special Emphasis on Herbal Medicine and Nutritional Supplements.

Herbal medicine and nutritional supplements are suggested to treat premenstrual somatic and psycho-behavioural symptoms in clinical guidelines; nonetheless, this is at present based on poor-quality trial evidence. Hence, we aimed to design a systematic review and meta-analysis for their effectiveness in alleviating premenstrual symptoms. The published randomized controlled trials (RCTs) were extracted from Google scholar, PubMed, Scopus and PROSPERO databases. The risk of bias in randomized trials was assessed by Cochrane risk-of-bias tool. The main outcome parameters were analysed separately based on the Premenstrual Symptom Screening Tool and PMTS and DRSP scores. Secondary parameters of somatic, psychological, and behavioural subscale symptoms of PSST were also analysed. Data synthesis was performed assuming a random-effects model, and standardized mean difference (SMDs) was analysed using SPSS version 28.0.0 (IBM, Armonk, NY, USA). A total of 754 articles were screened, and 15 RCTs were included (n = 1211 patients). Primary results for participants randomized to an intervention reported reduced PSST (n = 9), PMTS (n = 2), and DSR (n = 4) scores with (SMD = -1.44; 95% CI: -1.72 to -1.17), (SMD = -1.69; 95% CI: -3.80 to 0.42) and (SMD = 2.86; 95% CI: 1.02 to 4.69) verses comparator with substantial heterogeneity. Physical (SMD = -1.61; 95% CI = -2.56 to -0.66), behavioural (SMD = -0.60; 95% CI = -1.55 to0.35) and mood (SMD = 0.57; 95% CI = -0.96 to 2.11) subscale symptom groupings of PSST displayed similar findings. Fifty-three studies (n = 8) were considered at low risk of bias with high quality. Mild adverse events were reported by four RCTs. Based on the existing evidence, herbal medicine and nutritional supplements may be effective and safe for PMS.

Current Insights on Bioactive Molecules, Antioxidant, Anti-Inflammatory, and Other Pharmacological Activities of Cinnamomum camphora Linn.

C. camphora is a renowned traditional Unani medicinal herb and belongs to the family Lauraceae. It has therapeutic applications in various ailments and prophylactic properties to prevent flu-like epidemic symptoms and COVID-19. This comprehensive appraisal is to familiarize the reader with the traditional, broad applications of camphor both in Unani and modern medicine and its effects on bioactive molecules. Electronic databases such as Web of Science, PubMed, Google Scholar, Scopus, and Research Gate were searched for bioactive molecules, and preclinical/clinical research and including 59 research and review papers up to 2022 were retrieved. Additionally, 21 classical Unani and English herbal pharmacopeia books with ethnomedicinal properties and therapeutic applications were explored. Oxidative stress significantly impacts aging, obesity, diabetes mellitus, depression, and neurodegenerative diseases. The polyphenolic bioactive compounds such as linalool, borneol, and nerolidol of C. camphora have antioxidant activity and have the potential to remove free radicals. Its other major bioactive molecules are camphor, cineole, limelol, safrole, limonene, alpha-pinene, and cineole with anti-inflammatory, antibacterial, anxiolytic, analgesic, immunomodulatory, antihyperlipidemic, and many other pharmacological properties have been established in vitro or in vivo preclinical research. Natural bioactive molecules and their mechanisms of action and applications in diseases have been highlighted, with future prospects, gaps, and priorities that need to be addressed.

Role of Inflammation, Oxidative Stress, and Mitochondrial Changes in Premenstrual Psychosomatic Behavioral Symptoms with Anti-Inflammatory, Antioxidant Herbs, and Nutritional Supplements.

Premenstrual syndrome (PMS) significantly lowers the quality of life and impairs personal and social relationships in reproductive-age women. Some recommendations are that inappropriate oxidative stress and inflammatory response are involved in PMS. Various nutritional supplements and herbs showed neuro-psycho-pharmacological activity with antioxidant and anti-inflammatory properties. This study aims to determine the systematic review of randomized controlled trials (RCTs) of herbal medicine and nutritional supplements in PMS. We also comprehensively highlighted the role of oxidative stress, inflammation, and mitochondrial changes on PMS with the application of computational intelligence. We used PRISMA and research question-based techniques to collect the data for evaluation of our study on different databases such as Scopus, PubMed, and PROSPERO from 1990 to 2022. The methodological quality of the published study was assessed by the modified Jadad scale. In addition, we used network visualization and word cloud techniques to find the closest terms of the study based on previous publications. While we also used computational intelligence techniques to give the idea for the classification of experimental data from PMS. We found 25 randomized controlled studies with 1949 participants (mean ± SD: 77.96 ± 22.753) using the PRISMA technique, and all were high-quality studies. We also extracted the closest terms related to our study using network visualization techniques. This work has revealed the future direction and research gap on the role of oxidative stress and inflammation in PMS. In vitro and in vivo studies showed that bioactive molecules such as curcumin, allicin, anethole, thymoquinone, cyanidin 3-glucoside, gamma-linoleic acid, and various molecules not only have antioxidant and anti-inflammatory properties but also other various activities such as GABA-A receptor agonist, serotonergic, antidepressant, sedative, and analgesic. Traditional Unani Herbal medicine and nutritional supplements can effectively relieve PMS symptoms as they possess many bioactive molecules that are pharmacologically proven for the aforementioned properties. Hence, these biomolecules might influence a complex physical and psychological disease process like PMS. However, more rigorous research studies are recommended for in-depth knowledge of the efficacy of bioactive molecules on premenstrual syndrome in clinical trials.

Efficacy of Acacia nilotica Linn. Pod's Sitz Bath plus Vaginal Pessary in Syndromic Management of Abnormal Vaginal Discharge: A Randomized Controlled Trial.

Objectives: Abnormal vaginal discharge (Sayalan al-Rahim) is a common public health problem that significantly disrupts the health-related quality of life (HRQoL). Syndromic management infers the concurrent treatment of two or more infections. Hence, a comparative, single-blind study was planned to determine the efficacy of Acacia (Acacia nilotica Linn.) pod's sitz bath (Abzan) plus vaginal pessary (Farzaja) vs. placebo in abnormal vaginal discharge syndromic management, its associated symptoms, and women's HRQoL. Methods: Diagnosed patients (n = 66) were randomly divided into Acacia (n = 33) and placebo (n = 33) group. Acacia group received Sitz bath with Acacia pod powder (30g) solution followed by vaginal cotton pessary (5 ml of the same solution) once daily for 10 days. The placebo group received palm sugar powder (30g) solution for Sitz bath plus vaginal cotton pessary same as the Acacia group. Primary outcomes included clinical cure assessed with VAS for symptoms and Modified McCormack Pain Scale (McPS) for pelvic tenderness. The secondary outcomes included were the EQ-5D-5 L questionnaire, TSQM questionnaire, sachet count, and microbiological cure. Overall, therapeutic cure included clinical and microbiological cure after treatment. Results: The overall therapeutic cure for bacterial vaginosis, cervicitis, and uncomplicated pelvic inflammatory disease was 100% (n = 7/7), 45.45% (n = 10/22), and 71.42% (n = 5/7), respectively, in the Acacia group, while in the placebo group none of the patients had responded. The VAS score for symptoms was significantly reduced in Acacia than in the placebo group. At each follow-up, the improvement in the EQ-5D-5 L level of HRQoL was significantly higher in the Acacia group than in the placebo group. Conclusion: Acacia would be an effective and safe alternative in syndromic management of abnormal vaginal discharge, associated symptoms, and improved women's HRQoL. Trial registration. This trial was registered in the Clinical Trials Registry of Indian Trials Website and given the identification no. CTRI/2018/02/012175 (dated: 27/02/2018).

Evaluation of general body temperament and uterine dystemperament in amenorrhoea: a cross-sectional analytical study.

OBJECTIVES: Amenorrhoea in women of reproductive age may be an indication of an undiagnosed and chronic condition. The concept of temperament is a fundamental component of health preservation and diagnosis of various disease conditions including amenorrhoea in Unani medicine. Dystemperament is the commonest cause of various diseases. Therefore, general body temperament and uterine dystemperament in amenorrhoea was determined. METHODS: A prospective, single-centre, cross-sectional observational study from June to November 2019 was conducted in 80 patients of reproductive age with amenorrhoea ≥60 days. Validated questionnaire for the assessment of women's general body temperament and clinical features of uterine dystemperament was used. The data were analysed by appropriate statistical analysis. RESULTS: The age of patients with amenorrhoea ranged from 14 to 50 years. The most prevalent general body temperament was cold (57.5%) and wet (60%). Cold and wet general temperament was more common at the age of 21-30 years (30 and 36.25%), 60-90 days of amenorrhoea (33.75 and 32.5%) and body mass index (BMI) ≥25 kg/m2 (47.5 and 50%). The most prevalent uterine dystemperament was cold and dry (95%). A significant correlation between general temperament with age, amenorrhoea and BMI >23 kg/m2 was noted. Moreover, the cold temperament of the body had a significant correlation with cold uterine temperament (r=0.864, p<0.001). CONCLUSIONS: This study corroborated the claim of Unani scholars that cold and wet general and uterine temperament is more common in amenorrhoea and obesity. However, amenorrhoea can also occur in normal and other temperaments.

Clinical efficacy of Trigonella foenum graecum (Fenugreek) and dry cupping therapy on intensity of pain in patients with primary dysmenorrhea.

OBJECTIVE: To determine the effificacy and safety of fenugreek seed and dry cupping on intensity of pain in primary dysmenorrhea. METHODS: Sixty patients with primary dysmenorrhea were enrolled in this prospective, open-labeled, randomized, standard-controlled study, conducted in the National Institute of Unani Medicine Hospital between February 2010 and April 2011. In group A (20 cases), 3 g powder of fenugreek seed (3 capsules, 1 g each) was given orally twice daily from day 1 to 3 of menstrual cycle. Group B (20 cases) received the same dose of fenugreek seed as group A along with dry cupping therapy [two 4.2-cm and one 2.5-cm cups (internal diameter)], which was applied below the umbilicus for 15 min on day 1 and day 3 of menstrual cycle for 3 consecutive months. The control group C (20 cases) was given mefenamic acid, 500 mg twice daily, on the same protocol. The reduction in menstrual pain intensity was measured with well validated Visual Analogue Scale and safety of fenugreek seed was evaluated by clinical examination and laboratory investigations. RESULTS: Baseline characteristics and biochemical parameters were comparable and homogenous among all groups (P>0.05). The percentage reduction in lower abdominal pain was 66.89%, 66.49%, and 62.88% in A, B and C groups respectively at the end of the treatment. No adverse drug effects were noticed. CONCLUSION: The fenugreek seed and dry cupping are effificacious, safe, cost effective, and well tolerated.

Accelerated stability studies of Sufoofe Sailan: A Unani formulation.

INTRODUCTION: Sufoofe Sailan (SS) is a polyherbal powder preparation used in Unani medicine to treat gynecological diseases. It is observed that SS degrade early as it is in the form of powder; however, the stability study of SS was not carried out till date. AIM: To evaluate the accelerated stability of SS. MATERIALS AND METHODS: Finished formulation of SS was packed in three airtight transparent polyethylene terephthalate containers. One pack was analyzed just after manufacturing and remaining two packs were kept in stability chamber at 40°C ± 2°C/75% ± 5% RH, of which one pack was analyzed after the completion of three and another after 6 months. Organoleptic, physico-chemical, microbiological parameters along with high-performance thin layer chromatography (HPTLC) fingerprinting were carried out. RESULTS: Organoleptic characters showed no significant change in accelerated stability condition. All physico-chemical parameters showed changes <5%, HPTLC fingerprinting showed minimum changes and microbial studies were in confirmation to the World Health Organization guidelines. CONCLUSION: SS confirmed to the International Conference on Harmonization Guideline for accelerated testing of the pharmaceutical product on said parameters and as per the Grimm's statement the shelf life of SS may last 20 months.

Preliminary physicochemical evaluation of Kushta tutia: A Unani Formulation.

BACKGROUND: Kushta is an important solid dosage form of Unani system of medicine used to treat various ailments. Very small particle size of kushta is responsible for its rapid absorption in body leading to instant therapeutic actions. Kushta tutia (KT) is one such renowned formulation used by hakims for successful management of various disorders. However, there is lack of scientific work on KT. OBJECTIVES: The present study was performed to evaluate KT physicochemically by testifying it on classical tests along with modern scientific techniques. MATERIALS AND METHODS: Tutia was first detoxified as per classical literature. It was triturated with water and dried, afterwards subjected to calcination in furnace rather than cow dung cakes due to isolation of material being heated and better temperature control. Finished product was evaluated for physicochemical characteristics including preliminary tests mentioned in classical literature. RESULTS: Floating and finger test were positive. Curd test showed no discoloration after 48 h. These findings indicate correct preparation of KT according to classical literature. Bulk density (0.96 ± 0.00 g/ml); tapped density (1.53 ± 0.00 g/ml); Hausner ratio (0.62 ± 0.00), compressibility index (37.52 ± 0.19%); loss of weight on drying (0.08 ± 0.00%); pH of 1 and 10% (5.20 ± 0.00) and 5.62 ± 0.00, respectively); total ash, acid insoluble ash, and water soluble ash values 95.75 ± 0.09, 6.57 ± 0.02, and 45.02 ± 0.20%, respectively; and extractive values 0.85 ± 0.02% were reported in KT. CONCLUSION: Since this work has not been reported earlier, the results obtained could be considered as the standard for KT for future studies.

Efficacy of Boswellia serrata L. and Cyperus scariosus L. plus pelvic floor muscle training in stress incontinence in women of reproductive age.

INTRODUCTION: To determine the efficacy of combining of Boswellia serrata L. resin and the root of Cyperus scariosus L. plus PFMT in reproductive age women with stress urinary incontinence. METHODS: A prospective, single-blind, placebo-controlled, randomized trial was conducted. The patients were randomized to receive orally either combination of equal quantity of B. serrata and C. scariosus (2g) (n = 30) or placebo (n = 30) respectively twice daily for 8 weeks in addition to pelvic floor muscle training in both groups. The outcome was one hour pad test. The results were analyzed using parametric and nonparametric test. RESULTS: The improvement in the test and control group was 60% and 37% respectively. Between the group comparison was statistically significant (P = 0.035). The intra group comparison of one hour pad test was statistically significant in both groups (P < 0.001). No adverse effects were noted. CONCLUSION: The test group was more effective than control group in women with SUI.