CTRI/2015/11/006333尚未招募2 期
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE ROLE OF DIET THERAPY AND VYOSHADI SAKTU IN OBESITY
Government Ayurveda Medical college Mysore1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年11月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Decrease in body weight and body mass index
研究概览
简要总结
This study is a randomized, parallel group, single-centre trail comparing the efficacy of diet therapy and Vyoshadi saktu for 30 days in 60 patients with obesity that will be conducted in Govt. ayurveda Medical college, Mysore in India, The primary outcome measures will be Decrease in body weight and body mass index, Decrease in waist circumference and waist hip ratio (anthropometric measurements). The secondary outcomes will Decrease in cholesterol, Triglycerides, LDL and VLDL values from baseline Increase in HDL values from baseline Increase in the levels of serum calcium and BMD
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Elevated levels of lipid profile •BMI between >30 to 40kg/m2 •Willing to come for regular follow-up visits •Able to give written information consent.
排除标准
- •â€¢Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months •Pathophysiological/ genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Prader willi syndrome) •Patients with evidence of malignancy •Patients with poorly controlled Diabetes Mellitus (HbA1c> 10%) •Patients with poorly controlled Hypertension (>160/100 mm Hg) •Patients on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc.
- •or any other drugs that may have an influence on the outcome of the study •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders etc.) •Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infraction, Stroke or Severe Arrhythmia in the last 6 months •Symptomatic patient with clinical evidence of Heart failure.
- •â€¢Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2.5 times upper normal limit) or Renal Disorders (defined as S.Creatinine > 1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD), or any other condition that may jeopardize the study.
- •â€¢History of HIV and other viral infections •Alcoholics and/or drug abusers •Prior surgical therapy for obesity •History of hypersensitivity to any of the herbal extracts or dietary supplements.
- •â€¢Pregnant/ lactating women.
- •â€¢Patients who have completed participation in any other clinical trial during the past six (03) months.
- •â€¢Any other condition which the principal investigator thinks may jeopardize the study.
结局指标
主要结局
Decrease in body weight and body mass index
时间窗: 30 days
Decrease in waist circumference and waist hip ratio (anthropometric measurements)
时间窗: 30 days
次要结局
- Decrease in cholesterol, Triglycerides, LDL and VLDL values from baseline(Increase in HDL values from baseline)
研究者
研究点 (1)
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