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

•A double-blind-randomized-controlled trial.•Low dose combination of Turmeric and Black seeds are effective in metabolic syndrome.•Turmeric and Black seeds with lifestyle modification can be recommended in MetS.

SummaryObjectiveTo compare the clinical efficacy of Black seeds and Turmeric alone and its co-administration in lower doses among patients with metabolic syndrome (MetS).DesignDouble-blind-randomized-controlled trial.SettingHijrat colony, Karachi, Pakistan.InterventionApparently healthy males (n = 250), who screened positive for MetS, were randomized to either Black seeds (1.5 g/day), Turmeric (2.4 g/day), its combination (900 mg Black seeds and 1.5 g 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).ResultsAt 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.ConclusionTurmeric 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.