Anti-obesity activity of Leaf and stem bark of Mahanimba(Melia azedarach Linn.): In-silico, In-vitro and Exploratory clinical study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement in Objective (Weight, BMI, Body circumference, Lipid Profile, LFT) and subjective (Gradings) parameters
研究概览
简要总结
INTRODUCTION
Obesity is a concern of public health. Overweight and obesity are lifestyle illnesses that contributes to numerous chronic diseases, including cancers, diabetes, metabolic syndrome, and cardiovascular diseases. Mahanimba is one such tree which is having Tikta and Kashaya rasa and which is well cited in ancient Ayurveda classics with wide indications i.e. Bhrma (giddiness), Chardi (vomiting), Kushta (skin diseases), Hrullas (nausea), Raktavikara , Prameha. These rasa are well cited for medohara action in our ancient texts. Botanically it is identified as Melia azedarach Linn. The tree has been evaluated for its in-vitro antiviral activity, anti-fungal activity, in vitro acaricidal activity, anti-oxidant activity, in-vivo antidiabetic and gastric inhibitory activity etc. but its anti-obesity effect in In-silico, in In-vivo and clinical is yet to be explored. Thus, the present study is taken under consideration.
HYPOTHESIS
Null hypothesis (H0):
Mahanimba leaf ghan vati and stem bark ghan vati does not have anti-obesity activity in In-silico, In-vitro (PL inhibitory assay), and in obese patients.
Alternate hypothesis (H1):
Mahanimba leaf ghan vati and stem bark ghan vati have anti-obesity activity in In-silico, In-vitro (PL inhibitory assay), and in obese patients.
END POINT
The patients will be assessed on the basis of basis of reduction in BMI by 1 unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •BMI greater than 30 and less than equals to 40.
排除标准
- •Patients having grade II and III hepatomegaly.
- •Patients having history of Diabetes Mellitus, PCOD, Thyroid disorders and uncontrolled Hypertension.
- •Pregnant females and lactating women.
- •Patients having simultaneous intake of Anticonvulsant, Beta-blockers, Corticosteroid.
- •Patients taking any other medicines for obesity.
- •Any study participants condition which is considered by the investigating team to jeopardize.
结局指标
主要结局
Improvement in Objective (Weight, BMI, Body circumference, Lipid Profile, LFT) and subjective (Gradings) parameters
时间窗: 0th day, 30th, 60th and 90th day
次要结局
- • Change in Vitamin B12 levels.(• Comparative anti-obesity activity of leaf and stem bark of Mahanimba.)
研究者
Dr Aman Singhal
All India Institute of Ayurveda
