Comparative effect of Panchkol Churna against life-style modification as as a risk-reduction measure in participants at risk of cardiovascular disease.

Phase 2

• Conditions: Health Condition 1: I519- Heart disease, unspecified

• Registration Number: CTRI/2023/05/053143
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Stage :1 Inclusion Criteria:

1.Subjects of either gender in the age group of 30-60 years (both years inclusive).

2.Subjects fulfilling any one of the following criteria for abnormal lipid profile:

a)Subjects with Total cholesterol level ( >200mg/dl).

b)Subjects with Triglyceride level ( >150mg/dl).

c)Subjects with HDL level ( < 40mg/dl).

d)Subjects with LDL level ( >140mg/dl).

3.Subjects willing to participate and provide informed written consent

4.Participants fulfilling any three of the following criteria will be selected to participate in the survey:

i.Overweight/Class-1 obese (body mass index [BMI]: 25â??35 kg/m2), Subjects with low BMI but abnormal lipid profile, or subjects with both or at least any of the above diagnostic criteria will be selected for the study.

ii.Subjects having a family history of cardiovascular events like myocardial infarction, stroke, or peripheral vascular occlusive diseases.

iii.Subjects with history of tobacco smoking.

iv.Subjects with documented history of hypertension.

v.Subjects with documented history of diabetes mellitus.

5.Subjects with RAS-RCVD Score >=10.

6.Subject willing to participate and ready to give informed consent.

Stage 2:

1.Subjects at risk of CVDs diagnosed from observational study.

2.Subjects with RAS-RCVD Score >=10.

3.Subject willing to participate and ready to give informed consent.

Exclusion Criteria

Stage 1: Exclusion Criteria:

1.Subjects having history of cardiovascular events like myocardial infarction, stroke, or peripheral vascular occlusive diseases.

2.Subjects with documented history of hypertension.

3.Subjects with documented history of diabetes mellitus.

4.Patient with history of clinically-active hepatic or peptic ulcer disease.

5.Subjects planning to undergo surgery in next 3 months will be excluded from the study.

6.Subjects who are pregnant, breast feeding or planning to become pregnant during the study.

7.Subjects participated in any other clinical trials within thirty (30) days prior to screening.

8.Patient with history of severe allergy or anaphylactic reaction.

9.Any other condition which the investigator think may jeopardize the participant condition.

Stage 2: Exclusion Criteria:

1.Subjects having history of cardiovascular events like myocardial infarction, stroke, or peripheral vascular occlusive diseases.

2.Subjects with documented history of hypertension.

3.Subjects with documented history of diabetes mellitus.

4.Patient with history of clinically-active hepatic or peptic ulcer disease.

5.Subjects planning to undergo surgery in next 3 months will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified