Effectiveness of Turmeric and Kalongi in Metabolic syndrome

Phase 2

Recruiting

• Conditions: Metabolic syndrome; Alternative and Complementary Medicine - Herbal remedies; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12613001053718
• Lead Sponsor: Aga Khan University Medical College,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 248

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in multiple parameters of Metabolic syndrome <br>( Body weight/ waist circumference reduction and Blood pressure control measured by mercury sphyngmomanometer, Triglycerides, fasting blood sugar and serum HDL measured by cobas c111)[measured at baseline, 4 and 8 weeks];Improvement in insulin resistance measured by fasting serum insulin levels measured by ELECSYS Insulin Assay[measured at baseline and 8 weeks of intervention];improvement in inflammatory markers like C-reactive protein measured by cobas c111[measured at baseline and 8 weeks of intervention]

Secondary Outcome Measures

Name	Time	Method
body fat, muscle, bone percent (measured through bio impedence).<br>[2, 4, 6 and 8 weeks of Randomization];Adverse effect of treatment.[questions will be asked for any complains every week for 8 weeks monitoring adverse effects like nausea, dyspepsia, intolerance etc by a physician. participants will also be given an emergency contact number for any urgent symptoms they would like to report.]