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临床试验/CTRI/2024/11/077076
CTRI/2024/11/077076尚未招募2/3 期

Randomized controlled clinical study to evaluate the efficacy of Shatapushpadi Basti in the management of Prameha (Diabetes mellitus)

C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 4310111 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
92
试验地点
1
主要终点
Polyuria will be decreased

研究概览

简要总结

Nidanas (etiological factors) of Prameha according to Ayurved are said to be ’Asyasukham’ (sedentary lifestyle), ’Swapnasukham’ (excessive sleep), intake of ’Kaphakar ahara’ (food that causes vitiation of kapha dosha ), which collectively leads to Prameha. Predominant factors contributing to Prameha samprapti are kapha dushti (vitiated kapha dosha) which leads to agnimandya (decrease digestive fire) which further leads to Kleda utpatti and this kleda causes Strotorodha (obstructive pathology). To break this etiopathology, Ayurved has explained panchakarma,out of them one is basti . Achraya charak explained pramehaghana  basti in siddhisthan ,12th  adhyay. Selection of basti chikitsa in Prameha which contains contents of opposite Gunas (properties) of Prameha pathology may help break its pathology. So here Shatapushpadi Basti is selected.

Study will be conducted 92 diagonsed patient of Diabetes mellitus type II. Written consent will be taken. Initial assesment will be done. Patient treated with interventional group shatpushpadi basti and control group Madhutailika basti . Patient assessed at follow up.  Observation and result will be note and statistical analysis. Discussion and conclusion will be done.

Null Hypothesis: Shatapushpadi Basti is not effective in Prameha (Diabetes Mellitus).

Alternative Hypothesis: Shatapushpadi Basti is effective in the management of Prameha (Diabetes Mellitus).

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
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Clinically diagnosed patient of prameha .
  • Patient with Diabetes mellitus type II.
  • Subject having their fasting blood sugar more than 126 mg/dl and postmeal sugar more than 200mg/dl, B.M.I range 18 to 25 kg/m2 Basti chikitsa yogya patients.
  • Patient willing for trial and giving written consent.

排除标准

  • Patient below age 30 and above 60 years. patient with diabetes type I. DM associated with following condition.
  • Pregnancy ,Lactating women ,moderate to sever cardiovascular disease aand kidney disorder ,k/c/o any malignancy,k/c/o TB.

结局指标

主要结局

Polyuria will be decreased

时间窗: 24 days

Polydipsia will be decreased

时间窗: 24 days

Polyphagia will be decreased.

时间窗: 24 days

次要结局

  • Perspiration will be decreased.(Burning sensation will be decreased.)

研究者

发起方
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Ekta Suryabhan Tandekar

C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011

研究点 (1)

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