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.

Population study of Urban, Rural and Semi-urban regions for the detection of Endovascular disease and prevalence of risk factors and Holistic Intervention Study - PURSE-HIS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/04/001677

Enrollment

8025

Registered

2011-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: A. Modern medicine:1.Diabetes mellitus - Metformin,Glibenclamide 2. Hypertension- Amlodipine, Enalapril, Metoprolol 3. Dyslipidemia- Atorvastatin B. Siddha Medicine 1. Diabetes mellitus

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Achieving the target level of reduction of the risk factors: 1.Fasting blood sugar lessthan 110mg/dl, postprandial blood sugar 140- 160mg/dl and mean blood sugar lessthan 130mg/dl 2.Blood presssure lessthan 130/80mmHg in non-diabetic and 120/80mmHg in diabetic participants. 3. Total cholesterol level lessthan 200mg/dl, Triglyceride lessthan 150mg/dl, LDL-cholesterol lessthan 100mg/dl and HDL-cholesterol greater than 45mg/dlTimepoint: Achieving the target level of reduction of the risk factors every three months for a period of three years:	—

Measure

Time frame

Achieving the target level of reduction of the risk factors: 1.Fasting blood sugar lessthan 110mg/dl, postprandial blood sugar 140- 160mg/dl and mean blood sugar lessthan 130mg/dl 2.Blood presssure lessthan 130/80mmHg in non-diabetic and 120/80mmHg in diabetic participants. 3. Total cholesterol level lessthan 200mg/dl, Triglyceride lessthan 150mg/dl, LDL-cholesterol lessthan 100mg/dl and HDL-cholesterol greater than 45mg/dlTimepoint: Achieving the target level of reduction of the risk factors every three months for a period of three years:

—

Secondary

Measure	Time frame
Angina, Myocardial infarction, stroke, symptomatic peripheral vascular diseaseTimepoint: 3 years	—

Countries

India

Contacts

Public ContactDr S Thanikachalam

Deemed University

stsrmc@yahoo.com091-44-24766991

Outcome results