Three arm open label clinical trial to evaluate the efficacy of polyherbal compound in cardiometabolic tisk factors with special reference to NCEPATP III guidelines.

Phase 2

• Conditions: Health Condition 1: E889- Metabolic disorder, unspecifiedHealth Condition 2: E889- Metabolic disorder, unspecified

• Registration Number: CTRI/2022/08/044789
• Lead Sponsor: Centre of Research for Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

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

Inclusion Criteria

Group A - 10-Patients of Metabolic Syndrome. Patients have the presence of at least 3 criteria out of the following.

1. Waist Circumference in males > 40 inches. And in females > 35 inches.

2. Blood Pressure > 130/85 mm of Hg or on Antihypertensive treatment.

3. Fasting Triglycerides > 150 mm of Hg.

4. Fasting Blood Sugar > 100 mg/dl or on antidiabetic treatment.

5. Fasting HDL in Males < 40 mg/dl and in Females < 50mg/dl.

Group B - 10 - Patients of Pre-Metabolic Syndrome.

Inclusion Criteria-Patients having the presence of at least 2 criteria out of the following,

1. Waist circumference (W.C.) >90 cm for males and >80 cm for females.

2. Low HDL cholesterol (males <40 mg/dL and females <50 mg/dL, or under treatment.

3. High serum triglycerides ( >150 mg/dL, or under treatment),

4. Blood pressure ( >130/85 mmHg or under treatment,

5. Fasting blood glucose >100 mg/dL or under treatment.

Group C- 10 -Patients have the presence of only one component of Metabolic syndrome.

Exclusion Criteria

1. Patients below 18 yrs.

2. Patients over 70 yrs.

3. Pregnant or Breast-Feeding Patients,

4. History of Hepatic- Kidney or Thyroid Diseases,

5. History of allergy to Shigru, Amalaki, and Ashwagandha.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Polyherbal compound oral medication will assess for Blood sugar level for fasting and post prandial, Lipid profile, ESR and CRP level at 30 days and 60 days successive interval.Timepoint: 4th week and then 8th week.

Secondary Outcome Measures

Name	Time	Method
Validation of Ayurvedic diagnostic parameters of Samata in relation with modern investigations will establish as a new diagnostic profile.Timepoint: 24 Months.