CTRI/2015/04/005682已完成未知
A Randomized, Double Blind, Placebo Controlled, Multicentre Clinical Trial to Assess the Efficacy and Safety of Amla Extract (AMX160) in Patients with Dyslipidaemia
Arjuna Natural Extracts Ltd0 个研究点目标入组 98 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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
排除标准
- •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
研究者
相似试验
已完成
不适用
Clinical study to evaluate effectiveness, safety and efficacy of obinil Tablet in treatment of ObesityCTRI/2019/01/016879SAVA Healthcare Ltd
尚未招募
1 期
Clinical Study to Evaluate the Safety and Tolerability of in Healthy Human Volunteers for a period of 3 months for the safety endpoints.CTRI/2024/05/066786Himalaya Wellness Company
尚未招募
1 期
To Investigate the Safety & Tolerability of HDCD-092330 in Healthy VolunteersCTRI/2024/04/065687Himalaya Wellness Company
已完成
2 期
Clinical study on NC009 Biscuits as an immunity enhancer in healthy individualsCTRI/2021/11/037971BRITANNIA R and D CENTRE608
已完成
2 期
Clinical study on Passiflora Extract in tension and sleep problemCTRI/2022/07/043753JK Botanicals Private Limited