A Clinical Study to evaluate the efficacy and safety of Unani formulation (Sandroos and Sikanjabin) in the management of Siman Mufrit (Obesity) (IUMT-5.13.87)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Reduction in body weight
研究概览
简要总结
Title:"A Clinical Study to Evaluate the Efficacy & Safety of Unani Formulation (Sandroos with Sikanjabeen) in the Management of Siman Mufrit (Obesity)" **Researcher:**Dr. Aysha Khatoon, PG Scholar Department of Moalajat, State Takmeel-ut-Tib College & Hospital, Lucknow
**Objective:**To assess the efficacy and safety of a Unani formulation (Sandroos with Sikanjabin) in the treatment of Siman Mufrit (Obesity).
**Background:**Obesity is a growing global health concern, recognized by WHO as a chronic disease. It is characterized by excessive fat accumulation that impairs health and increases risk for several conditions such as diabetes, cardiovascular diseases, and hormonal disorders. In Unani medicine, obesity (Siman Mufrit) is viewed as a Balghami (phlegmatic) disorder due to cold temperament and metabolic imbalance.
**Unani Perspective:**Unani texts attribute obesity to causes like oily food (Tar Ghiza), sedentary lifestyle, and cold temperament (Sue Mizaj Barid). Management involves correcting temperament, eliminating excess phlegm, and enhancing metabolism using hot-dry temperament herbs.
Formulation Used:
- Sandroos (Trachylobium hornemannianum) – powder form (2.5 gm/day)
- Sikanjabin – sweet-sour syrup (25 ml/day) These are selected for their muhazzil (emaciating), muhallil (resolvent), and diuretic properties.
Methodology:
- Study Design: Single-arm pre-post interventional trial
- Sample Size: 38 patients (aged 18–60) with BMI between 25–35 kg/m²
- Duration: 42 days of treatment with 18 months total study time
- Inclusion/Exclusion Criteria: Standard criteria based on age, BMI, health status, and informed consent
Assessment Parameters:
- Reduction in body weight and BMI
- Improvement in signs/symptoms (e.g., joint pain, dyspnea, lethargy)
- Laboratory safety parameters (CBC, LFT, RFT, RBS)
- Adverse effects monitoring
**Conclusion (Proposed):**The trial aims to provide evidence for the scientific validation of traditional Unani treatments for obesity, ensuring both efficacy and safety in a controlled clinical setting.
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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
- •Patients with clinically diagnosed Siman Mufrit (obesity) of either sex Patients belonging to 18-60 years of age Patients having BMI between 25-35kg m2 Patient able to participate in the study and ready to follow the instructions and sign the consent form.
排除标准
- •Patient below the age of 18 and above the age of
- •Patients having BMI more than 35kg m
- •Patients who refuse to give the written informed consent for the study.
结局指标
主要结局
Reduction in body weight
时间窗: Baseline , 2nd, 4th and 6th week
Reduction in BMI
时间窗: Baseline , 2nd, 4th and 6th week
Improvement in Total Sign and Symptoms Score
时间窗: Baseline , 2nd, 4th and 6th week
次要结局
- Improvement In the Quality of Life(Baseline ,2nd ,4th and 6th week)
研究者
AYSHA KHATOON
State Takmeel ut Tib College And Hospital