Abstract

AN OPEN LABELLED, RANDOMIZED, PLACEBO CONTROLLED CLINICAL TRIAL TO EVALUATE THE THERAPEUTIC EFFECT OF KAKAJANGHAADI GHANAVATI IN SUBJECTS WITH NIDRANASHA W.S.R TO PRIMARY INSOMNIA

Aniruddha*, Vijayendra G. Bhat and Shrilatha Kamath T.

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Abstract

Objective: To evaluate the therapeutic effect of Kakajanghaadi Ghanavati in Nidranasha (Primary Insomnia). Methodology: An open labelled, randomized, placebo controlled clinical trial to evaluate the therapeutic effect of Kakajanghaadi Ghanavati in subjects with Nidranasha w.s.r to Primary Insomnia was conducted on 70 patients from OPD and IPD of Shri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Udupi. Patients fulfilling diagnostic criteria of Primary Insomnia were enrolled for the trial and were allotted to two groups. Each group had 35 patients. Group A, trial group, was advised to take Cap. Kakajanghaadi Ghanavati, 500 mg, orally at night, after food, with warm water for 30 days whereas Group B was administered Cap. Placebo, 500 mg, orally at night, with warm water, after food, for 30 days. Cap. Kakajanghaadi Ghanavati and Cap. Placebo was prepared in SDM Pharmacy, Udupi. Assessment was done on 0th day, 15th day and 30th day. Subjective and objective parameters were scored by standard method and were assessed before and after treatment on 0th day and 30th day. All the parameters were analysed statistically using paired t test for numerical data and Wilcoxon signed rank test for ordinal data comparing on 0th day and 30th day within the group. In between the group the numerical data was compared using unpaired t test and ordinal data was compared using Mann-Whitney U test. Result: Both the groups had statistical significance in most of the parameters. Conclusion: Both trial group (Cap. Kakajanghaadi Ghana vati) and placebo were efficient enough to reduce the symptoms of Nidranasha while trial group showed comparatively better result.

Keywords: Nidranasha, Primary insomnia, Kakajanghaadi Ghana vati, placebo.