Obesity Control Through Leptogenic Drugs
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Leptin Level
研究概览
简要总结
The study was designed to explore an alternative approach to reduce weight in human beings using a polyherbal formulation. A polyherbal formulation named as Obesecure was developed after screening of local medicinal flora. The formulation was further improved after pilot studies and Phase-I Clinical Trials.
详细描述
Obesity is a common disease of developing countries including Pakistan. Obesity is a risk factor for many diseases which can be life-threatening or making the person unable to perform daily routine work. Obesity is considered a risk factor for different diseases like cardiovascular diseases, hormonal imbalance, infections, malignancies and chest problems. The leptin hormone has appetite suppressing and energy dissipation activity in the body. A screening study on animals was carried out to find out the leptin enhancing medicinal plants from locally available plants in Pakistan. This study was aimed to see the combined effects of the Leptogenic drug Obesecure on weight management.
Patients of age20 to 50 years with BMI more than 25, not taking any anti-obesity drugs one-month prior to start of study were enrolled. The Participants were randomly allocated to receive either Obesecure or placebo twice a day for three months in Shifa-ul-mulk Hospital, PRIEM Health Care Clinic (Pakistan) and Ria Eastern Medicine Clinic (Pakistan).
An acute toxicity study showed no adverse effect of taking Obesecure prior to clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of age20 to 50 years with BMI more than 25
- •Only those participants were included who were willing
- •Patients of any marital status were included
- •Only those participants were included who did not take any antiobesity drug one-month prior to start of study
排除标准
- •Taking an anti-obesity drug in the previous month
- •Allergic to laxative drugs
- •Recurrent weight gain history after antiobesity treatment
- •Liver disease
- •Taking hormonal therapy, menopausal women
- •Diabetes mellitus
- •Cardiac problem and hypertension
研究组 & 干预措施
Obesecure Capsules (Test Group)
A dose of 500mg capsule twice daily of Polyherbal formulation Obesecure was given in the test group for three months. Short term effectiveness was assessed by BMI calculation on follow up visit after two weeks and long term follow up was assessed by BMI and Leptin Level at three months.
干预措施: Leptin Human (Drug)
Plasicure (Control Group)
A dose of 500mg capsule twice daily of Placebo as Plasicure was given in the control group for three months. Short term effectiveness was assessed by BMI calculation on follow up visit after two weeks and long term follow up was assessed by BMI and Leptin Level at three months.
干预措施: Leptin Human (Drug)
结局指标
主要结局
Leptin Level
时间窗: 3 months
Appetite suppression and energy dissipation
BMI (kg/m²) at baseline
时间窗: 3 Months
weight reduction effects
次要结局
未报告次要终点
研究者
Hafiz Muhammad Asif
Clinical Trials Registrar for Shifaulmulk
Shifa Ul Mulk Memorial Hospital