title: Clinical efficacy of the co-administration of Turmeric and Black seeds (Kalongi) in metabolic syndrome - a double blind randomized controlled trial - TAK-MetS trial.
abstract: 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).
  
  
  METHODS
  Double-blind-randomized-controlled trial.
  
  
  METHODS
  Hijrat colony, Karachi, Pakistan.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Natural Product Research Unit, Department of Biological and Biomedical Sciences, The Aga Khan University Medical College, Karachi 74800, Pakistan. Electronic address: faridah.amin@aku.edu.
authors.forename: F
authors.initials: F
authors.lastname: Amin
authors.affiliation: Department of Medicine, The Aga Khan University Medical College, Karachi 74800, Pakistan. Electronic address: najmul.islam@aku.edu.
authors.forename: N
authors.initials: N
authors.lastname: Islam
authors.affiliation: Department of Endocrinology, Queens Hospital Center, Jamaica, NY 11432, United States. Electronic address: dsanila01@yahoo.com.
authors.forename: Nfn
authors.initials: N
authors.lastname: Anila
authors.affiliation: Natural Product Research Unit, Department of Biological and Biomedical Sciences, The Aga Khan University Medical College, Karachi 74800, Pakistan; College of Health Sciences, Mekelle University, PO Box 1871, Mekelle, Ethiopia(1). Electronic address: anwar.gilani@aku.edu.
authors.forename: A H
authors.initials: AH
authors.lastname: Gilani
mesh_terms: D000328:Adult; D030024:Curcuma / Q000737:chemistry*; D006801:Humans; D008297:Male; D024821:Metabolic Syndrome / Q000188:drug therapy*; D008875:Middle Aged; D031881:Nigella sativa / Q000737:chemistry*; D010154:Pakistan; D008517:Phytotherapy; D028321:Plant Preparations / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D028321:Plant Preparations
keywords: Black seeds; Clinical efficacy; Co-administration; Metabolic syndrome; Synergism; Turmeric