Clinical trial of Amla Extract in subjects with abnormal cholesterol levels.

Not Applicable

Completed

• Registration Number: CTRI/2017/02/007829
• Lead Sponsor: Arjuna Natural Extracts Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-08-22
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 39

Inclusion Criteria

1.Subjects aged 18-65 years.

2.Inactive population (defined as less than 150 minutes of moderate-intensity physical activity throughout the week, or less than 75 minutes of vigorous-intensity physical activity throughout the week, or less than an equivalent combination of moderate- and vigorous-intensity activity).

3.Subjects with abnormal lipid levels having Triglycerides >200 mg/dL, LDL cholesterol > 130 mg/dL and Total cholesterol > 200 mg/dL.

4.Subjects not taking any medication (including herbal product) for management of abnormal lipid levels since last 4 weeks .

5.Informed consent of the patient.

Exclusion Criteria

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

Cigarette smoking

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

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

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

2.Subjects 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.Subjects with very high triglyceride levels i.e. > 500 mg/dL.

4.Subjects with diabetes (FBS >150 mg/dL),, using insulin, glitazones. Subjects using other hypoglycaemics, dose of which is not stable in last one month.

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

6.Subjects with hepatic impairment (SGOT or SGPT levels > 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine >= 2.0 mg/dl).

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

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

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

10.Subjects 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