Efficacy of whole system ayurveda management protocol in major depressive disorder- A randomized controlled clinical trial.

Background: Major Depressive Disorder (MDD) is one of the common depressive disorder. MDD has high comorbidity and has greater implications on quality of life. Whole system Ayurveda management protocol (WSAP) is explored for it's possible role in management of MDD.

Objective: To evaluate the efficacy of Whole system Ayurveda management protocol on Major Depressive Disorder.

Material And Methods: Study was a randomized controlled trial. Total 50 patients of MDD meeting the DSM V criteria, age group 20-70 years of either sex participated in the study. They were randomly divided into two groups, control group received Escitalopram 10 mg twice a day and Ayurveda group was on WSAP. Interventions were for 60 days. Assessments were done through various clinical parameters like Hamilton Depression Rating Scale (HDRS), Hamilton Anxiety Rating Scale (HARS), Brief psychiatric rating scale (BPRS), Pittsburgh Sleep Quality Index (PSQI), WHO Quality of Life- BREF (WHOQOL-BREF), Clinical Global Improvement scale (CGI), UKU Side effect scale. Assessments during intervention was on every 15th day.

Results: Study showed that Ayurveda group produced significant outcome improvement compared to control group in HDRS (p = 0.01), HARS (p = 0.03), PSQI (p = 0.03), WHOQOL-Bref (p < 0.001) and UKU side effect scale (p = 0.02). Both the group showed improvements in all the parameters except in WHOQOL-Bref where Ayurveda group only showed improvements (p < 0.001). Effect size showed large effect in WHOQOL-Bref. Mild side effects were reported in control group and none in Ayurveda group.

Conclusion: WSAP was effective in management of MDD and had better side effect profile. Further studies needed.