Population survey for the prevalence of risk factors causing blood vessel damage to heart muscle, brain tissue or peripheral tissue and treat people either with Siddha Medicine or Modern medicine.

Phase 4

Completed

• Registration Number: CTRI/2011/04/001677
• Lead Sponsor: Dr S Thanikachalam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8025

Inclusion Criteria

For modern medicine intervention:

Inclusion: 1. Participants under the category of impaired glucose tolerance or impaired fasting glucose or diabetes.

2. Blood pressure greater than 140/90 mmHg for non-diabetic participants and greater than130/85 for diabetic participants.

3. Total cholesterol greater than 200mg/dl , Triglyceride greater than 150mg/dl , LDL-cholesterol greater than 100mg/dl

For siddha medicine intervention:

Inclusion:

1. Fasting Plasma Glucose between 110 - 149 mg/dl, Post Prandial Plasma Glucose level between 200 - 299 mg/dl

2.Total Cholesterol between 200 - 250 mg/dl, LDL-C between 130 - 159 mg/dl, HDL-C between 35 - 39 mg/dl, Triglycerides between 200 299 mg/dl

3.Systolic Blood Pressure between 135 - 159 mmHg or Diastolic Blood pressure between 85 - 99 mmHg

4.The subject must be newly detected with the presence of the risk factor or is previously detected and uses a single drug for the control of the same.

5.The subject has no history, evidence or past history of presence of End organ damage involving the heart or brain.

Exclusion Criteria

Any of the following is regarded as a criterion for exclusion from the study:

1. History of serious adverse effect or hypersensitivity reactions to the medication used in the treatment of subjects in any arm of the study.

2. Pregnant women and breast feeding

3. History of malignancy

4. Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT greater than1.5times ULN.

5. Uncontrolled serum CK greater than3 times ULN

6. Serum creatinine greater than 2.5mg/dl

7. Participation in another investigational drug trial within the previous 4 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified