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临床试验/CTRI/2022/12/047896
CTRI/2022/12/047896招募中2/3 期

Comparative clinical evaluation of trikatu churna and kalbhojanam in sthoulya.

Priyanka Sharma1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2022年8月12日最近更新:

试验速览

阶段
2/3 期
状态
招募中
入组人数
96
试验地点
1
主要终点
3. Changes in anthropometric parameters.

研究概览

简要总结

Sthoulya is defined as excessive production of meda dhatu alongwith mamsa dhatu in the body. This excessive production of meda dhatu and mamsa dhatu results a person to malformed body with penduloussphika,udara and stana and having lack of enthusiasm.Sthoulya is not an acute onset disease infact long term Nidana sevana leads to it.frequent and excess intake food which increase the kapha and medo dhatu ,sedentary lifestyle,lack of mental and physical excercise are main causes of sthaulya apart from beeja dosha.Sthaulya in modern parlance is equated with obesity .The key causes of obesity are also same as sthaulya ,increased consumption of energy-dense food high in saturated fats and sugars and reduced physical activity.Obesity and over weight pose a major risk for chronic diseases,includin type-2 diabetes,cardiovascular disease,hypertension and stroke,and certain forms of cancer.Thus,mortality and morbidty rete were high in obese persons as compared to others.According to WHO in 2016,more than 1.9 billion adults worldwide (39%) were overweight,and over 650 million (13%) were obese.The current trajectory of prevalence acceleration would result in almost half of the world’s population being overweight or obese by 2030.Prevelance of obesity in India is 40.3%.Therefore,its high time for world to follow Ayurvedic principles which aims to preserve swatha primarily.Among a large number of dietary strategies described in Ayurvedic classics,for swastha kalabhojanam intake of food at a scheduled time,and not ad libitum,is suggested to be the best strategy to confer good health.Kalabhojanma is described in context of agryasangraha i.e., interventions and materials that are of principal significance for acheiving a particular objective.This clearly implies that assuming that one follows every guidance of Ayurveda to acheive good health,but compromises or ignores just the kalabhojanam,sustainable health span may remain acheivable.Kalabhojanam,therefore,is an indespensable component to confer arogya.Finally,treating sthoulya challenges is a global priority,so kalabhojanam should be considered additional to medicinal approach.A number of herbals and herbo-mineral medicines are described in various ancient text of ayurveda for treating Sthoulya.As per Ashtanga Hridyam has described Triakatu Churna in his treatise for Sthoulya which is having ingredients like Shunthi,Maricha and Pippali.These drugs having Ushna,Laghu,Ruksha Guna and Deepana,Kapha-Vatahara and Sthaoulyahara properties mentioned in literature.

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研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patient willing to sign the consent form.2.The patients between the age group of 18 to 50 years of either sex presenting with clinical features of Sthaulya (obesity).
  • Patients having BMI more than or equal to 25Kg/m2.

排除标准

  • Age below 18 and above 50 years.
  • Patients with complicated and chronic disorder like nephroticsyndrome, hypothyroidism, jaundice, hepatitis, chronic infections andother serious diseases.
  • Patients having Obesity due to secondary causes such as druginduced or hormonal imbalance like contraceptive pills.
  • Pregnant women and lactating mother.
  • Patients suffering from Diabetes mellitus .
  • Systemic illness like Tuberculosis, Carcinoma and Endocrinedisorders like Cushing syndrome, Hypothyroidism.
  • Patient having the past history of M.I. & Unstable Angina.
  • Patient having Clinical Features of CCF.
  • Patient having the major renal or liver disorder.

结局指标

主要结局

3. Changes in anthropometric parameters.

时间窗: All measure in Time Frame: 30th day, 60th day, 90th day, 120th day.

1. Change in body weight.

时间窗: All measure in Time Frame: 30th day, 60th day, 90th day, 120th day.

2. Changes in BMI.

时间窗: All measure in Time Frame: 30th day, 60th day, 90th day, 120th day.

4. Changes in skin folds thickness.

时间窗: All measure in Time Frame: 30th day, 60th day, 90th day, 120th day.

5. Changes in lipid profile

时间窗: All measure in Time Frame: 30th day, 60th day, 90th day, 120th day.

次要结局

  • 1. Reduction in risk of type 2 diabetes mellitus Will be assessed by fasting blood sugar(level and Indian Diabetes Risk Score.)

研究者

申办方类型
Other [self]

研究点 (1)

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