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临床试验/CTRI/2023/07/055727
CTRI/2023/07/055727尚未招募2/3 期

Immediate effect of specific yogic postures on gastric motility in diabetes mellitus patients -a randomized controlled trial

Dr Kadagouda Patil1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2023年7月8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
68
试验地点
1
主要终点
Electrogastrogram (EGG)

研究概览

简要总结

Yoga, the Indian system of medicine, lay emphasis on asanas as an essential component of therapy based on its disease model. All asanas with breathing seems to offer deep stimulation by activating the basic autonomic reflexes specially acting on the enteric division of autonomic nervous system by the intra abdominal pressure changes. It also enhances a mechanical effect of laxation. According to the Indian system of health, the apanavata in the gastrointestinal tract influences other vatas in the body leading to various disorders.(18) Though widely practiced the impact of asanas is yet to be established.

Hence this is the study to see the effect of yoga asanas on gastrointestinal motility with the hypothesis that, after the practice of asanas there will be an increase in gastrointestinal motility in diabetes mellitus.

a. Grouping: Two groups-

Group 1- case group (n)=34 (Specific yogic postures)

Group 2-control group (n)=34 ( supine rest with breathing awareness)

a. Method:

1)       Subjects satisfying the selection criteria and who have agreed to give consent for participation in the study are assessed at baseline.

2)     Then subjects were randomized into two groups [group 1 and group 2].

3)       Pre EGG will be taken for both groups.

4)       Series of asanas will be performed by group 1 under the guidance of a yoga and naturopathy physician.

5)       Post EGG will be taken immediately after the intervention for both groups.

6)    The whole data acquisition will be done in a supine position.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

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

入选标准

  • Subjects with type 2 diabetes mellitus meeting the American Diabetic Association diagnostic criteria and those who are on oral anti diabetic therapy.

排除标准

  • Patients suffering with co-morbidity.
  • History of lactose intolerance, stroke, spinal cord injury.
  • Analgesics, opioid use in last week.
  • Insulin dependent.
  • Women during Menstruation.

结局指标

主要结局

Electrogastrogram (EGG)

时间窗: Baseline and immediately after the intervention

Random blood sugar (RBS)

时间窗: Baseline and immediately after the intervention

次要结局

未报告次要终点

研究者

发起方
Dr Kadagouda Patil
申办方类型
Other [self]

研究点 (1)

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