None listed
Conditions
Brief summary
The metabolic syndrome is a combination of certain metabolic abnormalities including Obesity, Diabetes, Dyslipidemia and Hypertension. These in combination are associated with increased risk of coronary heart disease, stroke, and cardiovascular mortality. South Asian countries including Pakistan contribute to the highest proportion of cardiovascular disease burden when compared with any other region globally. The management of early metabolic syndrome without overt Hypertension, Dyslipidemia and Diabetes is based on increasing physical activity and dietary modifications, which is a challenge for many patients. Complementary medicines including herbs like Turmeric and Kalongi are widely accepted and are a part of diet in many Asian countries. These can be used to prevent or as an adjuvant to control chronic diseases like Metabolic syndrome with fewer side effects, better acceptability and cost effectiveness. Therefore this study was done to determine the effectivenees of commonly used herbs like Kalongi and Turmeric in improving the parameters of Metabolic syndrome.
Interventions
Four parallel groups will be given intervention or placebo for 8 weeks. Look alike capsules will be used and the dose will be administered in 2 divided doses. Compliance will be encouraged by daily phone messages and it will be measured by drug diary. Refilling will be done when patients return the blister packs of capsules on a weekly basis.
Group 1: Kalongi (Nigella Sativa) group (2 gm/day)
Group 2: Turmeric (Curcuma Longa) group (3.2 gm/day)
Group 3: Combination of Turmeric and Kalongi group
Four parallel groups will be given intervention or placebo for 8 weeks. Look alike capsules will be used and the dose will be administered in 2 divided doses. Compliance will be encouraged by daily phone messages and it will be measured by drug diary. Refilling will be done when patients return the blister packs of capsules on a weekly basis. Group 1: Kalongi (Nigella Sativa) group (2 gm/day) Group 2: Turmeric (Curcuma Longa) group (3.2 gm/day) Group 3: Combination of Turmeric and Kalongi group (1.6 gm +1 gm/day) Group 4: Placebo (Wheat) group (2gm /day)
Sponsors
Aga Khan University Medical College,
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Obese males residing and permanent residents of Hijrat colony with a waist circumference of or >90 cm with any 2 more features of Metabolic syndrome (MS) who are not on any regular medications for Diabetes (pre-Diabetic), Dyslipidemia, blood pressure (pre hypertensive) or obesity and do not require any medications as per ATP III guidelines and American Diabetic Association guidelines for control of Diabetes or Hypertension.
Exclusion criteria
*Patients with known Diabetes, Hypertension or Coronary Heart disease or who require immediate pharmacological treatment. *Patients with wheat allergy. *Patients already taking Herbal supplements. *Patients on medications for Hyperlipidemia or Obesity. *Debilitated patients or patients on regular medications for chronic diseases like steroids, immunosuppressants and Warfarin will also be excluded.
Outcome results
None listed