Neem (Azadirachta Indica A. Juss) Capsules for Prophylaxis of COVID-19 Infection: A Pilot, Double-Blind, Randomized Controlled Trial.

CONTEXT: SARS-CoV-2 is a global public-health concern. Interventions to prevent infection are urgently needed. The anti-inflammatory and antiviral effects of neem make it a potential agent for COVID-19 prophylaxis. OBJECTIVE: The study intended to evaluate the prophylactic effects of neem capsules for persons at high risk of COVID-19 infection due to contact with COVID-19 positive patients. DESIGN: The research team designed a prospective, randomized, double-blind, placebo-controlled, parallel-design study. SETTING: The study was conducted at a single center in India. PARTICIPANTS: Participants were 190 healthcare workers at the hospital or relatives of patients with COVID-19 infection. INTERVENTION: Of the 190 participants, 95 were in the intervention group and 95 in the control group. Participants received 50 mg of a proprietary, patent-pending, neem-leaf extract or a placebo orally in capsules, twice a day for 28 days. OUTCOME MEASURES: The number of individuals positive for COVID-19 between baseline and follow-up on day 56 was the primary outcome measure. Secondary measures included an evaluation of neem's safety and its effects on quality of life (QOL) and changes in biomarkers. RESULTS: The mean age of participants was 36.97 years, and 68.42% were male. Total 13 subjects tested positive during the study. All were asymptomatic. Of the 154 participants who completed the study per-protocol, 11 tested positive, 3 in the intervention group and 8 in the control group. The probability of COVID-19 infection in participants receiving the intervention was 0.45 times that of participants receiving the placebo, a relative risk of 0.45, with the effectiveness of the intervention being around 55%. Treatment-emergent adverse events (TEAEs) in both groups were minimal and were of grade 1 or 2 in severity. Biomarkers and QOL remained stable in both groups. CONCLUSIONS: The study found a reduced risk of COVID-19 infection in participants receiving neem capsules, which demonstrates its potential as a prophylactic treatment for the prevention of COVID-19 infection. The findings warrant further investigation in clinical trials.

Role of Kasahara Dashemani Vati in Kasa and Vyadhikshamatva in children with special reference to recurrent respiratory tract infections.

The present single-centered randomized control trial (RCT) was carried out with the prime aim of assessing the effect of Kasahara Dashemani Vati (trial drug) on Kasa and Vyadhikshamatva in the children suffering from recurrent respiratory tract infections and comparing it with the efficacy of Indukanta Vati. The clinical trial included 40 patients belonging to age group of 3-12 years. The drugs were administered in a daily dose fixed as per "Clark's Rule" along with honey for duration of 60 days. The effect of treatment on the signs and symptoms of Kasa was assessed on the 15(th) day, whereas the effect on Vyadhikshamatva was assessed on the 60(th) day. The patients were under follow-up for a period of 60 days after completing the treatment course for evaluation of any recurrence. Effect of the therapy on the individual signs and symptoms of Kasa, laboratory parameters, immunoglobulin (Ig) biomarkers, status of Atura Bala, and prevention of recurrence during follow-up period were the parameters used to assess the overall effect of therapy. The observed data were subjected to appropriate statistical analysis for testing the statistical significance. Kasahara Dashemani provided relief in all symptoms of Kasa irrespective of Doshic involvement and on the parameters of Atura Bala. All the changes were statistically highly significant. The control group also showed similar effects which were statistically highly significant. The trial group was found to have a direct influence on serum Ig status. No patient has reported any adverse drug reactions during the treatment and follow-up periods.