A randomized, double blind, standard controlled trial to compare safety and efficacy of two leading brands of Ashwagandha products in patients suffering from mental health related symptoms
Abstract
Background: Mental health related symptoms are common among the population. Current treatment exhibits serious adverse effects, delayed onset of action and low efficacy. Ashwagandha has a variety of beneficial effects in mental health disorders. We did a comparison of two Ashwagandha brands using a variety of scales for anxiety, depression, stress, and sleep quality.
Methods: The study was conducted in 80 patients suffering from mental health related symptoms. Test product used was: Herbochem +91 Ashwagandha 500 mg capsules and control used was: KSM 66 Ashwagandha 600 mg capsules.
Results: The reduction in the perceived stress scores and Hamilton depression scale scores at day 30/60 from day 0 was higher in the test group as compared with the control group. The reduction in the Beck’s anxiety inventory scores at day 30/60/90 from day 0 was higher in the test group as compared with the control group. The increase in the Pittsburgh sleep quality index scores at day 30/60 from day 0 was higher in the test group as compared with the control group. The reduction in the serum cortisol scores at day 30 from day 0 was higher in the test group as compared with the control group. Results showed that, the incidence of adverse events was same in both groups.
Conclusions: It is important to note that test product having 500 mg Ashwagandha, showed better efficacy as compared to control product having 100 mg more (600 mg) of Ashwagandha.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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