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临床试验/CTRI/2025/01/078930
CTRI/2025/01/078930尚未招募不适用

A Randomized Controlled Clinical Trial To evaluate the efficacy between sthaulyahar kashay ghana vati and tab rosuvastatin in the management of medovruddhi in sthaulya with special reference to hyperlipidemia

PDEAs college of ayurveda and research centre , Nigadi Pradhikaran , Pune1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年2月1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
80
试验地点
1
主要终点
to get reduced BMI,

研究概览

简要总结

Obesity is one of the most challenging health issues in the present era. It almost felt like an epidemic problem now days. Not only developed but also the developing nations affected by this problem. Obesity is the complex, multifactorial type of nutritional metabolic disease. It is a medical condition in which body fat has accumulated to the extent that it has a negative effect on health. As we moved into rapid modernization, the lifestyle of an individual has become sedentary. Today anything is available at the one touch. Machine and smart gadgets’ have replaced manual labor. This leads to the lack of exercise and there is increased popularity of fat foods leading to impairment of metabolism. This leads to the disease called ‘Sthaulya ’which is under Sampraptijanya vyadhi’ as Medorog.It greatly increase risk of chronic diseases like disability, depression, type 2 DM, cardiovascular disease, Hyperlipidemia and many more serious mental problems.

There are many medicines available in allopathy for management of Hyperlipidemia. Some famous medicines are like Statins (Rosuvastatin, Atorvastatin etc.), Gemfibrozil, Ezetimibe, Bezafibrates etc., but there are some side effects such as myalgia,constipation,bloating.

So, it is necessary to find out some alternative medicine which will not harm towards body, which is human friendly and also a cost effective.one of ayurveda literature saharasrayog adviced one formulation called sthaulyahar kashay ghana vati contains‘Vara’, ‘asan ’, ‘agnaya, ‘lohapatra’, ‘nisha ’ churna with anupan ‘Madhu’.Above all ingredients have properties of ‘Kaphaghanta’, ‘Deepan’, ‘Lekhana’ and most of them are ‘Ushna’ and ‘Katu’. So this combination is taken in order to cause sampraptibhanga.Due to all this properties management of Sthaulya may be possible and it may also help in growth of saar medadhatu and leads to healthy individuals.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 39.9 kg/m2 B) SR CHOLESTEROL : ABOVE 200 mg/dl TO 350 mg/dl OR SR TRIGLYCERIDE : ABOVE 150 mg/dl TO 300 mg/dl OR SR LDL : ABOVE 150 mg/dl to 250 mg/dl C)patient having 2 or more symptoms 1 Ati sthaulya (excess hunger)2 Ati trushna (excessthirst)3 Ati swed (excess sweating)4 Ati shwas (breathlessness)5 Ati nidrata (excess sleep)6 ays akshamata (fatigue) above symptoms are from ashtang sangraha.

排除标准

  • K/C/O 1 renal impairement, IHD, TB, AIDS, CA, cerebral diseases, hepatitis, hypothyroidism 2 uncontrolled DM (HbA1C above 9 %) 3 autoimmune diseases and taking steroid therapy 4 pregnant and lactating women.

结局指标

主要结局

to get reduced BMI,

时间窗: 12 weeks follow up of 4 weeks

reduced trigyceride and cholesterol value,reduced symptoms of obesity as mentioned earlier

时间窗: 12 weeks follow up of 4 weeks

次要结局

  • to observe adverse effect,if any(12 weeks follow up of 4 weeks)

研究者

发起方
PDEAs college of ayurveda and research centre , Nigadi Pradhikaran , Pune
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR Mandar Pramod Garud

PDEAS college of ayurveda and research centre , nigadi , pune

研究点 (1)

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