Immunomodulatory effect of a proprietary polyherbal formulation on healthy participants: A single- blind, randomized, placebo- controlled, exploratory clinical study.

Context: Clinical study for immunity. Aims: The present study aimed to assess the effect of proprietary polyherbal formulation (PPHF), labelled as Kofol immunity tablets (KIT) on innate and adaptive immune responses in healthy individuals, on the backdrop of COVID-19 pandemic. Settings and Design: Single-blind, randomized, placebo-controlled, exploratory study in institutional setting. Materials and Methods: Post Ethics Committee permission, screened healthy individuals of either sex aged 18-35 years were randomized to PPHF/Placebo for 2 months. Major assessment variables included peak expiratory flow rate (PEFR), questionnaire-based immune status, perceived stress, and quality of life (QOL) with immune-specific cell counts (CD4+, CD8+), cytokines (interferon gamma [IFN-γ], tumor necrosis factor-alpha [TNF-α], interleukin 10 [IL-10]), and oxidative stress in red blood cells (RBCs) (malondialdehyde (MDA), glutathione peroxidase [GPx]), done at day 60. Statistical Analysis Used: Mean ± standard deviation and paired/unpaired t-test for parametric data analysis while median (range) and Wilcoxon Rank sum test/Mann-Whitney test for nonparametric data analysis, were done. Categorical data was analyzed using Chi-square test. GraphPad InStat software, version 9 was used with p < 0.05, as the level of statistical significance. Results: Of 52 recruited, 28 individuals completed the study. PPHF significantly increased PEFR, improved immune status along with QOL compared to baseline. It also decreased perceived stress from moderate and severe grade to mild. Serum IFN-γ levels remained almost constant post-PPHF treatment. PPHF significantly decreased MDA and increased GPx in RBCs. Significant decrease and increase in TNF-α and IL-10, respectively, were seen in PPHF group. The safety parameters post-PPHF treatment remained within normal reference ranges. Conclusions: PPHF is an efficacious and safe formulation with immunomodulatory potential.

Exploratory quasi-experimental study of anti-arthritic activity of Ayurvedic polyherbal formulation, Abha Guggulu in osteoarthritis patients.

OBJECTIVES: Abha Guggulu (AG) is a traditional Ayurvedic herbal formulation used for treating joint disorders and bone fractures. Individually, the ingredients are known for their promising anti-inflammatory and rejuvenating actions. The present study attempts to explore the anti-arthritic potential of AG through an exploratory clinical trial. METHODS: The study was conducted using a quasi-experimental model. The clinical trial has been registered in Clinical Trials Registry of India (registration number: CTRI/2019/09/021354). Osteoarthritis patients of both genders (n=12, 40-70 years age group), meeting the inclusion/exclusion criteria, were recruited in the single arm study. AG was administered in tablet form in a dose of 1.5 g, twice daily. The WOMAC score was used as a primary outcome measure. The WOMAC scale of patients was recorded on 0th, 15th and 30th days of treatment. RESULTS: At the end of treatment, there was a significant difference in the scores of the outcome measure. As per WOMAC total score, participants were significantly improved (p=0.002) after consuming the drug for 1 month. CONCLUSIONS: Overall, the data indicates significant improvement of subjects in both scales and objective measures used for assessment purposes. There were no adverse drug reactions reported during the trial. AG may be used as a safe and effective supplement to reduce symptoms of osteoarthritis. The clinical efficacy of the formulation might be mediated through the synergistic blend of herbal bioactive compounds from AG.

Efficacy and acceptability of pomegranate effervescent granules in patients suffering from acid peptic disorders.

CONTEXT: Acid peptic disorders. AIMS: This study aimed to assess the efficacy and acceptability of pomegranate effervescent granules (PEGs) in dyspeptic patients. SETTINGS AND DESIGN: It was a single-arm, open-labeled prospective multicentric clinical study, done at 3 centers: Vishwanand Kendra, Pune; Bharati Ayurved Hospital, Bharati Vidyapeeth, Pune, and M. A. Podar Medical Ayurved Hospital, Mumbai. The co-ordinating site was Interactive Research School for Health Affairs, Bharati Vidyapeeth, Pune. MATERIALS AND METHODS: The granules, prepared from peel extract of pomegranate, were made available in sachets of 2.5 g with dose of, 1 sachet dissolved in 200 ml (1 cup) of water, twice a day after meals for 28 days. Gastrointestinal Symptom Rating Scale (GSRS) scores to assess symptoms of acid peptic disorders at day 0, 15, and 29 along with the taste of formulation were the main study outcomes. STATISTICAL ANALYSIS USED: Parametric data, presented as mean ± standard deviation, were analyzed using paired t-test, while nonparametric data presented as median (range) was analyzed using Wilcoxon rank-sum test. Categorical data were analyzed using Chi-square test. RESULTS: The median GSRS score reduced from 14 on day 0-10 and then 5 on day 15 and day 29, respectively, with statistical significance. The formulation was found to taste good by ~80% of patients, while ~20% reported it to be palatable and none found it to be bad in taste. CONCLUSION: PEGs proved to be palatable, patient-friendly, safe, and efficacious in resolving symptoms of dyspepsia in acid peptic disorders. CTRI Registration: The trial was registered retrospectively in the Clinical Registry of India [CTRI/2017/07/008999].

A clinical study to evaluate the efficacy of Herbal Formulation for Obesity (HFO-02) in overweight individuals.

BACKGROUND: Ayurveda, the Indian system of medicine offers many herbs and formulations for management of obesity. Baidyanath Bhawan Pvt. Ltd has designed a formulation, HFO-02, based on Ayurvedic literature. OBJECTIVE: To evaluate the efficacy of Herbal Formulation for Obesity (HFO-02) in overweight individuals. MATERIALS & METHODS: With approval from the Institutional Ethics Committee, a proof of concept study was carried out in overweight individuals (Body Mass Index, BMI ≥25.0 and ≤ 30.0 kg/m2), devoid of any endocrinological disorders. Tablet HFO-02 (500 mg) was administered to these individuals twice daily for 90 days, during which they were called at study site fortnightly. After stopping the treatment, they were further followed up for 30 days off-medication and the last follow up was scheduled on day 120. Anthropometric parameters were assessed at every visit, while biochemical parameters viz. lipid profile, blood sugar & insulin levels (both fasting and post prandial), C- reactive protein and adipocytokines (leptin & adiponectin) were estimated monthly. RESULTS: Of the 18 participants recruited in the study; 14 completed the study. HFO-02 did not show reduction in weight, however a significant decrease in the body circumference and skin fold was demonstrated. This decrease was maintained till day 120. The levels of all biochemical parameters were maintained and no adverse events were reported throughout the study. CONCLUSION: Tablet HFO-02 reduced body circumferences and skinfold thickness indicating its potential for obesity management. CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2016/07/007067.

Evaluation of the efficacy and safety of Capsule Longvida® Optimized Curcumin (solid lipid curcumin particles) in knee osteoarthritis: a pilot clinical study.

Purpose: Osteoarthritis is the single most common cause of disability in older adults with an estimated 10% to 15% prevalence in individuals above 60 years. The contemporary medications include nonsteroidal anti-inflammatory drugs acetaminophen, cyclooxygenase-2 inhibitors, and surgical interventions. In view of safety issues regarding their longterm use, necessitating search for effective and safe alternatives, we evaluated Capsule Longvida® Optimized Curcumin prepared using solid lipid curcumin particles (SLCP) technology in patients with knee osteoarthritis. Patients and methods: Eligible patients fulfilling American College of Rheumatology Criteria were randomized to SLCP group (400 mg twice daily delivering 80 mg of curcumin per capsule) or Ibuprofen with placebo group (400 mg each once daily) for 90 days. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Visual Analog Scale (VAS) were used for clinical assessment of knee pain and function. Degree of knee flexion and swelling were also noted. Blood biochemistry included hemogram, blood urea, creatinine, Random blood sugar and inflammatory markers viz. PGE2, TNF α, IL6, IL1ß and LTB4 while urine examination included degenerative marker CTX II. The parametric data was analyzed using unpaired t test while non-parametric data was analyzed using Friedman's test or Mann Whitney t test as applicable. A level of p<0.05 was considered as statistically significant. Results: Out of 50 recruitments, 25 from the Ibuprofen group and 17 from the SLCP group completed the study with significant improvements in VAS and WOMAC scores indicating comparable efficacy of SLCP in alleviating pain with Ibuprofen. None of the markers displayed significant changes. Except one withdrawal in the study group due to rash and itching, the study drug was found safe. Conclusions: SLCP in a dose of 160 mg daily was found to be effective and safe in alleviating symptoms in patients suffering from knee osteoarthritis when administered for 90 days.