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

Three arm open label clinical trial to evaluate the efficacy of polyherbal compound in cardiometabolic risk factors with special reference to NCEP ATP III Guidelines.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/044789

Enrollment

Registered

2022-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: E889- Metabolic disorder, unspecified Health Condition 2: E889- Metabolic disorder, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

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 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 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

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

India

Contacts

Public ContactDr Hrishita Sandeep Dahilekar

Parul Institute of Ayurved & Research Ishwarpura Parul University Vadodara

pandithrishita@gmail.com9420090602

Outcome results