An open label single arm clinical study to evaluate the safety and efficacy of PR/HC/17-18/003 formulation for weight management in obese or overweight patients.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction of Body weight
研究概览
简要总结
An open label single arm clinical study to evaluate the safety and efficacy of PR/HC/17-18/003 formulation for weight management in obese or overweight subjects. The efficacy outcomes include decrease in body weightand body mass index, change in anthropometric parameters , change in leptin and CRP levels, decreasein Total Cholesterol, LDL Cholesterol, VLDL Cholesterol and Triglycerides, increase in HDLCholesterol, . Safety outcomes for the study involve adverse and serious adverseevents, vital signs and laboratory investigations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Male and or female patients.
- •2 Age between 20 to 50 years.
- •3 BMI between 25 to 40 kg/m
- •4 Willing to come for regular follow-up visits.
- •5 Able to give written informed consent.
排除标准
- •1 Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months.
- •2 Pathophysiologic/ genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Praderwilli syndrome).
- •3 Patients with evidence of malignancy.
- •4 Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%).
- •6 Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •7 Symptomatic patient with clinical evidence of Heart failure.
- •8 Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin,Alkaline Phosphatase (ALP) > 2 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.
- •9 History of HIV and other viral infections.
- •10 Alcoholics and/or drug abusers.
- •11 Prior surgical therapy for obesity.
- •12 History of hypersensitivity to any of the herbal extracts or dietary supplement.
- •13 Pregnant / lactating woman.
- •14 Patients who have completed participation in any other clinical trial during the past six (06) months.
- •15 Any other condition which the Principal Investigator thinks may jeopardize the study.
结局指标
主要结局
Reduction of Body weight
时间窗: Baseline, Day 30,Day 60 and Day 90
Improved anthropometric measurements (waist circumference, waist: hip ratio)
时间窗: Baseline, Day 30,Day 60 and Day 90
Reduction of BMI
时间窗: Baseline, Day 30,Day 60 and Day 90
Change in leptin & CRP level
时间窗: Baseline, Day 30,Day 60 and Day 90
Lipid profile
时间窗: Baseline, Day 30,Day 60 and Day 90
QOL Questionnaire
时间窗: Baseline, Day 30,Day 60 and Day 90
次要结局
- Safety and Tolerability(Adverse events (AEs), frequency and severity.)