EVALUATION OF EFFICACY AND SAFETY OF “TEST DRUG” IN PATIENTS SUFFERING FROM PRIMARY INSOMNIA- A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, COMPARATIVE, INTERVENTIONAL, MULTI-CENTRIC, PROSPECTIVE, CLINICAL STUDY

Dr. Vinod Kuber, Gayatri Ganu*, Dr. Gunwant Yeola and Dr. Narendra Mundhe

ABSTRACT

Background: “Test drug”, a polyherbal formulation developed by Sava Healthcare Ltd, for management of primary insomnia. Objective: The main objective of the study was to evaluate efficacy and safety of “Test drug” in comparison to placebo in patients suffering from primary insomnia. Materials and Methods: Randomized, double blind, placebo controlled, comparative, interventional, multi-centric, prospective, clinical Study. Patients were randomly assigned to drug or placebo groups and advised to consume 2 tablets after night meal for 28 days. Medication was stopped from 28th to 35th day to check rebound insomnia. Student paired and unpaired t test s, Mann Whitney U test, Chi Square tests were used for data analysis. Results: The mean total sleep time and sleep efficiency were significantly improved in drug Test drug compared to placebo. Test drug tablet was significantly effective in reducing time to sleep onset, total number of awakenings, wake time after sleep onset and severity of insomnia. Sleep quality was also significantly improved. Stoppage of treatment for seven days did not show rebound of insomnia. No significant post treatment change in any of the lab investigations was observed in both the groups. Conclusion: Test drug is safe and effective for the treatment of primary insomnia without rebound insomnia effect.

Keywords: Test drug, Tablet, Primary Insomnia, Placebo, Randomized, Double Blind.