Target Institute of Medical Education & Research

Abstract Background: Passiflora incarnata is used for treating anxiety or nervousness, generalized anxiety disorder (GAD), insomnia, and other related disorders. Previous studies indicate that passion flower has a positive effect on sleep patterns. It reduces the time to fall asleep and increases the duration of sleep. Objectives: To Evaluate Efficacy and Safety of Passiflora incarnata (Passion Flower) Extract in participants with Stress and Insomnia Methods: In a Randomized, Double Blind, Placebo Controlled, Multi-centre, Interventional, Prospective Clinical Study, a total of 65 participants with stress and insomnia were screened and recruited and randomised to two groups (32 in the Passiflora group and 33 in the Placebo group). The participants were randomized either to Passiflora incarnata (Aerial Parts) Extract group or placebo group in 1:1 ratio. Subjects were asked to take given product at bed time with water for 30 days. Subjects were evaluated on Day 1, Day 15 and Day 30 on Perceived Stress Scale (PSS), subject’s Quality of Life on GHQ12 Scale. Subject’s insomnia was evaluated on Insomnia Severity Index. Appropriate statistical tests were applied to the data derived from the clinical study to draw inferences. Results: Statistically significant reduction in mean score of stress on PSS and mean score of total sleep time were observed with the use of Passoflora extract as compared to placebo. The general psychological health significantly improved in Passiflora group compared to placebo group on day 15 and day 30. Passiflora Extract was found to be safe without producing any adverse effects. Conclusion: Passiflora incarnata(aerial parts) extract was significantly effective in reducing stress and other related symptoms. It improved sleep time and quality of sleep with no adverse events.

Evaluate the efficacy of AYUSH 64, a standard polyherbal Ayurvedic drug in COVID-19. During the first pandemic wave, 140 consenting and eligible hospitalized adult participants with mild-moderate symptomatic disease (specific standard RT-PCR assay positive) were selected as per a convenience sample, and randomized (1:1 ratio) to an open-label (assessor blind) two-arm multicentric drug trial; standard of care (SOC as per Indian guidelines) versus AYUSH 64 combined with SOC (AYUSH plus). Participants were assessed daily and discharged once clinical recovery (CR, primary efficacy) was achieved which was based on a predetermined set of criteria (resolution of symptoms, normal peripheral oximetry, and negative specific RT-PCR assay). Each participant was followed using an indigenous software program(mobile phone) and completed a 12-week study period. The dose of AYUSH 64 was 2 tablets oral, 500 mg each, bid for 12 weeks (AYUSH plus only). Significant P was <0.05 (two-sided). On randomization, the groups were found well matched. The mean interval time from randomization to CR was significantly superior in the AYUSH plus group [mean 6.45 days versus 8.26 days, 95% Confidence Interval of the difference -3.02 to -0.59 (P = 0.003, Student's 't test] as per-protocol analysis (134 participants); significant (P = 0.002) on an intention to treat analysis. 70% of the participants in AYUSH plus recovered during the first week (P = 0.046, Chi-square) and showed a significantly better change in physical health, fatigue, and quality of life measures. 48 adverse events, mostly mild and gut related, were reported by each group. There were 20 patient withdrawals (8 in AYUSH plus) but none due to an AE. There were no deaths. Daily assessment (hospitalization) and supervised drug intake ensured robust efficacy data. The open-label design was a concern (study outcome). AYUSH 64 in combination with SOC hastened recovery, reduced hospitalization, and improved health in COVID-19. It was considered safe and well-tolerated. Further clinical validation (Phase III) is required. CTRI/2020/06/025557.

Abstract Background: Anti-inflammatory and analgesic activities of Curcuma longa extract can be helpful in the management of Osteoarthritis. Objectives: to evaluate the anti-inflammatory and analgesic activities of AQUATURM® (branded extract of Curcuma longa) in individuals suffering from Osteoarthritis of Knee joint Methods: In present randomized, double blind, placebo controlled clinical study, a total 60 participants suffering from Osteoarthritis of the knee joint were randomized in two groups through a double-blinded procedure. AQUA-TURM® or its matching placebo was given in a dose of 1 capsule of 250 mg twice daily after meals for 90 days. Of these, 56 subjects completed the study (26 in AQUA-TURM® group and 30 in placebo group). Assessment of comparative change in knee joint pain on VAS, WOMAC Index was done on monthly intervals. Other parameters like time to walk 50 feet, requirement of painkillers, changes in the CRP levels and safety assessment through adverse event monitoring and laboratory parameters was done. Results: A significant reduction (p &lt; 0.05) in pain was observed on VAS scale with the use of AQUA-TURM® as compared to placebo over a period of 90 days. On the WOMAC index, significant reduction (p &lt; 0.05) was observed on the domains of pain and stiffness. A significant reduction was observed on CRP levels. AQUA-TURM® did not produce any significant adverse effects on clinical and laboratory parameters and was well tolerated. Conclusion: Supplementation of AQUATURM® in individuals suffering from Osteoarthritis of Knee joint showed significant reduction in pain and swelling showing its analgesic and anti-inflammatory effect.

Abstract Background: Guduchi (Tinospora cordifolia), a well-known Ayurvedic Herb used both as a preventive and curative remedy for various infections and immunity related conditions. Objective was to evaluate Guduchi Ghana Vati as a preventive remedy for COVID-19 and other non-COVID-19 infections in healthy population.Methodology: This was an open labelled, multi centric, randomized, comparative, interventional, prospective community based clinical study on healthy individuals at community level in five different districts of Rajasthan under National Institute of Ayurveda, Jaipur, Rajasthan. Participants were divided into two groups in which one group received Guduchi Ghana Vati as the intervention for a period of 45 days while participants in the other group did not receive any intervention. Comparative assessment of incidence of COVID-19 and non-COVID-19 infections, its severity and requirement of hospitalization was done. Assessment of safety was done through assessment of adverse reactions. Results: Of a total of 10022 participants who completed the study, the rate of infection with COVID19 was observed to be lower in those taking Guduchi Ghana Vati as compared to those not taking it however the difference was statistically non-significant. The number of episodes and severity of infection related illnesses (non-COVID 19) was found to be less in participants taking Guduchi Ghana Vati as compared to those not taking it; the difference was statistically significant too. No major adverse drug reactions were observed.Conclusion: Guduchi Ghana Vati is a safe and effective remedy for the prevention of infection and immunity related conditions including COVID19.

ABSTRACTObjectivesTo compare the co-administration of an Ayurvedic drug AYUSH 64 as an adjunct to standard of care (SOC) and SOC for efficacy and safety in the management of COVID-19.DesignMulticentre, parallel efficacy, randomized, controlled, open label, assessor blind, exploratory trial with a convenience sample. Patients followed to complete 12 weeks of study duration.SettingCOVID-19 dedicated non-intensive care wards at 1 government hospital, 1 medical college teaching hospital and 1 medical university teaching hospitalParticipants140 consenting, eligible, hospitalized adult patients suffering from mild and moderate symptomatic COVID-19 and confirmed by a diagnostic (SARS-CoV-2) RT-PCR assay on nasal and throat swab were randomized to SOC or SOC plus AYUSH 64. To be withdrawn if disease becomes severe.InterventionsTwo tablets of AYUSH 64, 500 mg each, twice daily after meals, and continued till study completion. SOC (symptomatic and supportive) as per national guidelines of India for mild and moderate disease.Main outcome measuresTime period to clinical recovery (CR) from randomization baseline and proportion with CR within 28 days time frame; CR defined in the protocolResults140 patients randomized (70 in each arm); 138 patients with CR qualified for analysis. Both groups were matched at baseline. The mean time to CR from randomization was significantly superior in AYUSH 64 group (95% CI -3.03 to 0.59 days); a higher proportion (69.7%) in the first week (p=0.046, Chi-square). No significant differences observed for COVID-19 related blood assays (such as D-Dimer). AYUSH 64 arm showed significant (p&lt;0.05) superior persistent improvement in general health, quality of life, fatigue, anxiety, stress, sleep and other psychosocial metrics. 1 patient on SOC required critical care. 48 adverse events (AE) reported in each group. Barring three SAE (in SOC), AE were mild and none were drug related. 22 participants (8 on AYUSH) were withdrawn. No deaths were reported.ConclusionsAYUSH 64 hastened recovery, reduced hospitalization and improved overall health in mild and moderate COVID-19 when co-administered with SOC under medical supervision. It was safe and well tolerated. Further studies are warranted.Trial registrationThe Clinical Trials Registry India Number CTRI/2020/06/025557FundingCCRAS, Ministry of AYUSH, Government of India