A clinical trial to study the effect of Shunthyadam Vati to prevent heart disease.

A randomized open label clinical study to evaluate the efficacy of Shunthyadam Vati in preventive cardiology on atherosclerotic cardiovascular disease (ASCVD) risk estimate using Framingham score.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/01/030275

Enrollment

200

Registered

2021-01-06

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

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery Health Condition 2: I00-I99- Diseases of the circulatory system Health Condition 3: I10- Essential (primary) hypertension Health Condition 4: I10- Essential (primary) hypertension Health Condition 5: I30-I52- Other forms of heart disease

Interventions

Intervention1: Shunthyadyam Vati(Shunti,Bramhi,Hingu,DadimAmlavetasa): A 250mg tablet to be given in oral form twice a day after meal for 100 patients for three months along with diet chart according

Eligibility

Inclusion criteria

Inclusion criteria: Patiens having signs and symptoms of Hridroga (cardiac diseases) having LDL levels greater than 130 mg/dl and total cholesterol greater than 160 mg/dl.

Exclusion criteria

Exclusion criteria: patients with a 10 year fatal CVD RISK SCORE 3x ULN, TSH ULN ,TRIGLYCERIDES > 400 mg/dl: abnormal life threatening ECG pattern and any other chronic diseases.

Design outcomes

Primary

Measure	Time frame
Imrovement in clinical signs and symptoms of sbjective parameter according to book gradation and biochemical parameters For high risk patient reduction in Framingham Risk score for ASCVD by 20% For intermediate risk patient reduction in score by 10% will be expected outcomeTimepoint: 4 weeks	—

Secondary

Measure	Time frame
â?¢To demonstrate relief from clinical signs and symptoms of Hridroga (Cardiac diseases) by Shunthyadam Vati in patients prone to risk factors like obesity, smoking, high Low density lipoprotein (LDL) cholesterol, low High density Lipoprotein (HDL) cholesterol ,uncontrolled hypertension (HTN)/ hypo tension, physical inactivity, uncontrolled diabetes mellitus (DM), under stressful circumstances. â?¢Evaluate the safety and tolerability of Shunthyadam Vati. Timepoint: 12 weeks	—

Measure

Time frame

â?¢To demonstrate relief from clinical signs and symptoms of Hridroga (Cardiac diseases) by Shunthyadam Vati in patients prone to risk factors like obesity, smoking, high Low density lipoprotein (LDL) cholesterol, low High density Lipoprotein (HDL) cholesterol ,uncontrolled hypertension (HTN)/ hypo tension, physical inactivity, uncontrolled diabetes mellitus (DM), under stressful circumstances. â?¢Evaluate the safety and tolerability of Shunthyadam Vati. Timepoint: 12 weeks

—

Countries

India

Contacts

Public ContactDr Gunvant Hari Yeola

Dr,D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune-18

abhijitshekhar00@gmail.com09764546495

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026