To observe the effect of Ayurvedic medicine for the treatment of Obesity with abnormal lipid profile

A Randomized, Double-Blind, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of an Ayurvedic formulation (Slim MetS) in patients with Metabolic Syndrome (MetS)

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039315

Enrollment

Registered

2022-01-11

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Male and Female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference > 102 cm (M) or >88 cm (F), and two or more of these criteria: 1. fasting blood glucose >100 mg; 2. systolic blood pressure >135 or diastolic blood pressure >85 mmHg 3. triglyceridemia >150 mg/dl; 4. HDL cholesterolemia 5. Patient willing to participate in the study for 12 weeks.

Exclusion criteria

Exclusion criteria: 1. Patients with diabetes mellitus (FBS >126mg/dl); 2. Patients with blood pressure more than 160/100 mmHg. 3. Triglyceridemia > 500 mg/dl; 4. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders etc). 5. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia. 6. Symptomatic patients with clinical evidence of heart failure, hepatic failure and renal failure (serum creatinine >2 mg/dl). 7. Alcoholics and/or drug abusers. 8. Pregnant and lactating mothers 9. Any other condition which the Investigator thinks may jeopardize the study.

Design outcomes

Primary

Measure	Time frame
Change in waist circumference (WC) Change in Body Mass Index (BMI) Change in Insulin Resistance using Homeostatic model assessment (HOMA-IR) index Change in Insulin Resistance using quantitative insulin sensitivity check index (QUICKI) Timepoint: 3 months	—

Secondary

Measure	Time frame
Change in lipid profile Change in systolic and diastolic blood pressure Change in blood glucose and insulin level Change in Renal function & liver function Timepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Harbans Singh

Central Ayurveda Research Institute

dr.harbans@rediffmail.com09501248820

Outcome results