A Pilot Clinical Study to evaluate Efficacy and Safety of Polyherbal formulation (Obegar G150) in management of Obesity.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in BMI and Blood lipid levels.
研究概览
简要总结
This is a prospective, open label, Pilot-clinical trial for 28 days. Total 30 Obese patients will participate in single group through eligibility criteria. Outpatients of age 18-60 years, of either sex having Body Mass Index (BMI) >25kg/m2 Will be included in this study after written informed consent.30 patients will receive tablet Obegar G150 (polyherbal formulation) Orally, 500 mg, Twice a day, daily after meal, for 28 days.
Subjective Parameters and clinical assessment through body fat monitor will be assessed at baseline, 14th, and 28th day. Laboratory Parameters (Lipid Profile) will be done at Screening/baseline and after completion of the study period i.e.28 thdays.
All the relevant data regarding the clinical study will be collected and
presented in tabular form. The observations and results obtained from clinical
study will be analyzed statistically to evaluate the significance of the curative
properties of therapies.
conclusion will be drawn as per the results drawn from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Obese Patients above 18 years to 60 Years.
- •2.Both Male and female sex included in trial.
- •3.Patients with Body mass index(BMI)more than 25kg/m2 4.Patients having signs and symptoms of Sthaulya(Obesity) as Per ayurveda and modern texts.
排除标准
- •Patient having any systemic disorders which require long term drug treatment 2)Patients with Body Mass Index (BMI) more than 40kg/m2 3)Patients with complaint of Cardiovascular diseases 4)Pregnant women, ascites, portal hypertension 5)Unable to provide written informed consent.
结局指标
主要结局
Change in BMI and Blood lipid levels.
时间窗: TIME POINTS-14TH-28TH DAY FOLLOW UP WILL BE TAAKEN FOR Subjective Parameters and clinical assessment through body fat monitor will be assessed at baseline, 14th, and 28th day. Laboratory Parameters (Lipid Profile) will be done at Screening/baseline and after completion of the study period i.e.28 th days.
次要结局
- Change in Visceral fat% and other clinical sign symptoms of Obesity(TIME POINTS-14TH-28TH DAY FOLLOW UP WILL BE TAKEN FOR Subjective Parameters and clinical assessment through body fat monitor will be assessed at baseline, 14th, and 28th day. Laboratory Parameters (Lipid Profile) will be done at Screening/baseline and after completion of the study period i.e.28 th days.)
研究者
Dr Santosh Kamble
Dr D.Y.Patil College Of Ayurved and Research Centre,Pimpri,Pune-18.Dr.D.Y.Patil Vidyapeeth,Pune