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临床试验/CTRI/2025/04/085349
CTRI/2025/04/085349尚未招募不适用

Anti-obesity activity of Leaf and stem bark of Mahanimba(Melia azedarach Linn.): In-silico, In-vitro and Exploratory clinical study.

All India Institute of Ayurveda, New Delhi1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5月18日最近更新:

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

发起方
All India Institute of Ayurveda, New Delhi
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Aman Singhal

All India Institute of Ayurveda

研究点 (1)

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