Clinical efficacy of the co-administration of Turmeric and Black seeds (Kalongi) in metabolic syndrome - a double blind randomized controlled trial - TAK-MetS trial.

OBJECTIVE To compare the clinical efficacy of Black seeds and Turmeric alone and its co-administration in lower doses among patients with metabolic syndrome (MetS). DESIGN Double-blind-randomized-controlled trial. SETTING Hijrat colony, Karachi, Pakistan. INTERVENTION Apparently healthy males (n=250), who screened positive for MetS, were randomized to either Black seeds (1.5g/day), Turmeric (2.4g/day), its combination (900mg Black seeds and 1.5g Turmeric/day) or placebo for 8 weeks. MAIN OUTCOME MEASURES body-mass-index (BMI), body-fat-percent (BF%), waist-circumference (WC), hip-circumference (HC), blood pressure (BP), lipid-profile (cholesterol, HDL-cholesterol, LDL-cholesterol and TG), fasting blood glucose (FBG) and c-reactive protein (CRP). RESULTS At 4 weeks, compared to baseline, Black seed and Turmeric alone showed improvement in BMI, WC and BF%. Combination improved all parameters except HDL-cholesterol with lower FBG and LDL-cholesterol as compared to placebo. At 8 weeks, compared to placebo, Black seeds reduced lipids and FBG, while Turmeric reduced LDL-cholesterol and CRP. Interestingly, combination group with 60% dose of the individual herbs showed an improvement in all parameters from baseline. When compared to placebo, it reduced BF%, FBG, cholesterol, TG, LDL-cholesterol, CRP and raised HDL-cholesterol. CONCLUSION Turmeric and Black seeds showed improvement in all parameters of metabolic syndrome, when co-administered at 60% of doses of individual herbs with enhanced efficacy and negligible adverse-effects. The combination of Black seeds and Turmeric can therefore, be recommended with lifestyle modification as a starting point for patients with MetS to halt its future complications and progression.