Evaluating the safety and efficacy of a polyherbal Unani formulation in dyslipidaemia-a prospective randomized controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE

Unani System of Medicine offers treatment for obesity and dyslipidaemia. Jawarish Falafili (JF) is a Unani polyherbal pharmacopoeial preparation. It has been used in the treatment of obesity for a long time. Dyslipidaemia is a recognised modifiable risk factor for hypertension, ischemic heart disease and stroke. Limitations of the current conventional therapy have provided scope for research of a potential drug in this medical condition. It was hypothesised that JF may ameliorate dyslipidaemia in human participants.

AIM OF THE STUDY

The main objective of this study was to evaluate the safety and efficacy of the JF.

MATERIALS AND METHODS

This was a prospective randomized, active-controlled, open-label and parallel-group study. We randomized 74 participants of dyslipidaemia into treatment (n = 38) and control (n = 36) groups. Of them, 30 participants in each group completed the trial. The participants of any sex aged between 30 and 60 years, with serum total cholesterol (TC) ≥200 mg/dl and/or serum triglycerides (TG) ≥150 mg/dl and/or low-density lipoprotein cholesterol (LDL-C) level ≥130 mg/dl and/or high-density lipoprotein cholesterol (HDL-C) level <40 mg/dl were enrolled in this study. The participants of the treatment group were treated with JF (10 gm/day) once and atorvastatin (20 mg/day) was given to the control group for 90 days once at night daily.

RESULTS

We observed a significant reduction (treatment group versus control group) in mean serum TC by 22.89% versus 19.36%, TG by 29.90% versus 23.26% and LDL-C by 29.16% versus 27.92% from baseline (p < 0.05). But the change in mean serum HDL-C levels post-treatment was insignificant in both groups (p > 0.05). On intergroup comparison, the magnitude of the difference of mean TC, TG, LDL-C and HDL-C levels between the groups was not statistically significant (p > 0.00.05).

CONCLUSIONS

This study concluded that JF and atorvastatin were equally effective in controlling dyslipidaemia. They were tolerated well by all participants and found safe during the course of treatment.

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