To study the effect of licorice on patients with gene polymorphism
Phase 2
- Conditions
- Health Condition 1: null- Type 2 diabetics, metabolic syndrome and polycystic ovary syndrome subjects showing 11 beta HSD-1 gene polymorphism
- Registration Number
- CTRI/2015/09/006171
- Lead Sponsor
- RSSDI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Patients who sign informed consent
Type 2 diabetics confirmed by ADA criteria
Metabolic syndrome subjects confirmed by IDF criteria
Polycystic ovary syndrome subjects confirmed by rotterdam criteria
Exclusion Criteria
Type 1 diabetes
Diabetics on insulin
Subjects with HbA1C >9.5%, FBS >200 mg/dl,
BP >160/100,eGFR >30%
Known hypokalemia
Oedema
Women of child bearing potential
Currently on alcohol abuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change from baseline FBS, PPBS and fructosamine. <br/ ><br>2.Proportion of patients who maintain good short term glycemic control without the need of additional antidiabetic medication. <br/ ><br>3.Change from baseline weight, waist circumference 4.Change from baseline in total cholesterol, LDL, HDL, triglycerideTimepoint: 3 weeks
- Secondary Outcome Measures
Name Time Method Proportion of patients who show hypokalemia, oedema, elevation of blood pressure of 5 mmHg or more and other side effectsTimepoint: Baseline and every week upto 3 weeks