A Randomized, Double Blind, Placebo Controlled, Multicentre Clinical Trial to Assess the Efficacy and Safety of Amla Extract (AMX160) in Patients with Dyslipidaemia

Not Applicable

Completed

• Registration Number: CTRI/2015/04/005682
• Lead Sponsor: Arjuna Natural Extracts Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-11-22
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 98

Inclusion Criteria

1. Patients aged 30-65 years

2. Patients with dyslipidaemia having Triglycerides (TG) >200 mg/dL,

LDL cholesterol > 130 mg/dL,

Total cholesterol > 200 mg/dL

and

HDL cholesterol < 40 mg/dL for men and < 50 mg/dL for women

3. Patients not taking any medication (including herbal product) for management of dyslipidaemia since last 4 weeks

4. Informed consent of the patient

Exclusion Criteria

1. Patients with more than 2 of the following risk factors -

1.1. Cigarette smoking

1.2. Hypertension (BP > 140/90 mmHg or on antihypertensive medication)

1.3. Family history of premature CHD (CHD in male first degree relative < 55 years; CHD in female first degree relative < 65 years)

1.4. Age (men > 45 years; women > 55 years)

2. Patients with uncontrolled cardiovascular disease or advanced atherosclerosis (e.g. history of stroke, myocardial infarction, life-threatening arrhythmia, or coronary revascularization within the preceding 6 months; unstable angina; congestive heart failure; known or suspected clinically significant valvular heart disease or uncontrolled hypertension ( > 160/100 mm of Hg or use of antihypertensive medications, dose of which is not stable in the last one month))

3. Patients with very high triglyceride levels i.e. > 500 mg/dL

4. Patients with FBS more than 150 mg/dL, using insulin, glitazones. Patients using other hypoglycaemics, dose of which is not stable in last one month

5. Pregnancy, lactation and female patients not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)

6. Patients with hepatic impairment (SGOT or SGPT levels > 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine greater than or equal to 2.0 mg/dl)

7. Patients with any other severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures

8. Patients with known history of hypersensitivity to amla or any product containing amla extract

9. Patients with continuing history of alcohol and / or drug abuse.

10. Patients with any other serious concurrent illness or malignancy.

11. Participation in another clinical trial in the past 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified