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临床试验/CTRI/2024/10/074665
CTRI/2024/10/074665已完成不适用

The Effect of Yoga and Gastro Hepatic Pack on Type II Diabetes Mellitus: A Randomized Three Arm Study

Dr. Laimujam Preety Devi1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年10月16日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
1.Analysis of Glycated Haemoglobin : ADH has recommended HbA1c ≥ 6.5% for diagnosing diabetes

研究概览

简要总结

A category of metabolic illnesses known as diabetes are characterised by hyperglycemia brought on by deficiencies of insulin production, action or both. Diabetes persistent hyperglycemia is linked to long term harm, malfunction and failure of several organs. Many people with diabetes, especially type II DM in the early stages of the disease, do not exhibit any symptoms. However certain people with severe hyperglycemia particularly in children with total insulin shortage, may experience polyuria, polydipsia, polyphagia, weight loss and impaired vision. In India a prevalence of 77.0 million in 2016, 101.0 million by 2030 and 134.2 million by 2045. Diabetes related behavioural and emotional abnormalities are appertained to as diabetes related distress. Complications are the most significant complaint specific motorist of quality of life in people with diabetes and have been constantly demonstrated to prognosticate emotional distress in similar people. The measure of perceived stress is not the quantity of stressful events that occur in a person’s life, but rather the individual’s perception of the overall stress of their life and their ability to manage it. Yoga, an Indian practice, is beneficial to balance metabolism by lessening the damaging effects of stress and calming down the HPA axis and sympathoadrenal activation and enhanced insulin sensitivity at target tissues. The Gastro hepatic pack, a naturopathic treatment, can improved diabetes distress, perceived stress and glucose levels. However, more studies are needed to validate the effects of yoga and GH pack on Type II DM. This study focuses on their impact on patient with Type II Diabetes Mellitus.

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

入选标准

  • •Type II Diabetes Mellitus.
  • •meeting the American Diabetic Association Diagnostic criteria and those who are on oral anti diabetic therapy.
  • •Already diagnosed, at least 1 year
  • •People who are willing to participant in the study.

排除标准

  • •1.Type I Diabetes or Gestational Diabetes
  • •Participants on insulin injection
  • •Participant had recently undergone serious operations
  • •Cardiac, renal and proliferative renal complication
  • •Pregnancy
  • •Patients who are sick and disabled.

结局指标

主要结局

1.Analysis of Glycated Haemoglobin : ADH has recommended HbA1c ≥ 6.5% for diagnosing diabetes

时间窗: 3 months

2.Fasting blood sugar : ≥ 126 mg/dL, no calorie intake for at least 8 hours

时间窗: 3 months

3.Postprandial plasma glucose : 2 hour ≥ 200 mg/dL

时间窗: 3 months

次要结局

  • 1.Diabetes distress scale : a score is ≥3, then it is a high level of distress(2.Perceived stress scale : scoring ranging from)

研究者

发起方
Dr. Laimujam Preety Devi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Laimujam Preety Devi

SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka

研究点 (1)

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