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effect and safety of turmeric on vascular function in diabetics

Not Applicable
Completed
Conditions
Health Condition 1: null- Type 2 diabetes mellitus patientsHealth Condition 2: E119- Type 2 diabetes mellitus without complications
Registration Number
CTRI/2016/10/007401
Lead Sponsor
JIPMER Intramural fund
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
136
Inclusion Criteria

Native Tamilian patients with type 2 diabetes mellitus diagnosed within the past 3 months to 10 years, on stable dose of metformin with or without sulfonylureas, for at least past 3 months

Exclusion Criteria

1)Liver dysfunction (AST,ALT > 2 times the upper limit of normal)

2)Renal dysfunction (GFR <60 ml/min)

3)Patient with concurrent illnesses like CAD(Coronary Artery Disease), CVA( cerebrovascular accidents), PVD(Peripheral Vascular Disease), CKD( Chronic Kidney Disease)other than hypertension

4)Patients taking anti diabetic drugs other than metformin and sulfonylureas

5)Pregnant women or lactating mothers; women in reproductive age group not practicing contraceptive measures.

6)Patients who had participated in other trials in the past three months.

7)Those on other herbal medications.

8)Current smokers

9)alcoholics

10)Patients with active infections such as diabetic foot infection etc

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
carotid femoral pulse wave velocityTimepoint: baseline,1st,2nd,3rd month
Secondary Outcome Measures
NameTimeMethod
1.arterial stiffness index, ankle brachial index, aortic systolic/diastolic pressures, augmentation pressure, augmentation index <br/ ><br>2. ICAM and VCAM <br/ ><br>3. adiponectin and leptin <br/ ><br>4. the adverse drug reactions(ADR)to Curcuma longaTimepoint: 1.At baseline, At the end of 1st month, 2nd month <br/ ><br>and 3rd month <br/ ><br>2.baseline and 3 months <br/ ><br>3.baseline and 3 months <br/ ><br>4.1st,2nd and 3rd month
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