Effect of Unani drug on Dyslipidemia

Phase 2/3

Not yet recruiting

• Conditions: Other disorder of circulatory system,

• Registration Number: CTRI/2020/09/027924
• Lead Sponsor: National Institute of Unani Medicine

Brief Summary

This study is a open labelled, randomized, controlled, clinical trial comparing the safety and efficacy of arq biranjasif 125ml once a day before meal and tab Atorvastatin 10mg once a day for 8 weeks in 100 patients with dyslipidemic pateints will be conducted in Bangalore, Karnataka, India. The primary outcome measures will be Change in lipid profile level.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-09-23
• Study Start: 2020-10-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Known cases of Dyslipidemia with disease history of < 3yrs with or without anti hyperlipidemic medication. Total Cholesterol > 200- 239mg / dl27 Triglycerides < 499 mg / dl (High) LDL >189 mg / dl27 HDL < 40 mg / dl in men and <50 woman27 VLDL >0.930–1.006 g/ L5 Ratio HDL to LDL < 6.3 in men and 5 in woman Patients of both sex Age: between 20-50 yrs BMI ≤39.929 Known cases of DM type -2 with Dyslipidemia Fasting blood sugar (FBS) > 126 mg/dl.
• < 150mg/dl30 Post Prandial blood sugar (PPBS) > 140 mg/dl.
• < 250mg/dl 5 Normotensives ( < 130 – 80 mm of Hg) Patients who follow the protocol.

Exclusion Criteria

• Known cases of Dyslipidemia, with disease history of > 3yrs Total Cholesterol > 240 mg / dl Triglycerides > 499 mg / dl (High)27 LDL < 189 mg / dl 31 HDL > 70 mg / dl VLDL <0.930–1.006 g/L Ratio LDL to HDL >6.3 in men and >5 in woman Known cases of Type 2 Diabetes Mellitus with complications.
• Fasting Blood Sugar >150 mg/dl32 Post Prandial blood sugar (PPBS) > 250mg/dl Known cases of Hypertension 33Diabetes Mellitus type I, Hypothyroidism Known cases on use of corticosteroids, and contraceptives.
• History of cardiovascular, Renal, Liver diseases, AIDS and T.B. History of alcoholism BMI ≥ 40 Pregnant & lactating mothers Age < 20 and > 50 years of age.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Lipid profile	8 weeks

Trial Locations

Locations (1)

National Institute of Unani Medicine, Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

National Institute of Unani Medicine, Bangalore

🇮🇳Bangalore, KARNATAKA, India

Farooqui Shazia

Principal investigator

8147438868

shaziafarooquinium@gmail.com