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临床试验/CTRI/2017/09/009812
CTRI/2017/09/009812尚未招募未知

Effect of Yoga on psychological, cognitive and glycemic control in patients with T2DM and Depression: Two arm parallel Randomized controlled trial

Applied for funding to Department of Science and Technology Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1 Type 2 diabetes
  • 2 Age > 30 years
  • 3 Willing to come for Yoga sessions/study visits in AIIMS as per module
  • 4 On basis of HbA1c depending upon type of therapy
  • a)>= 7.5% to <= 9% if only on oral drugs ± basal insulin
  • b)>= 7.5% to <= 10 %, if on premix insulin for >= 6 months, and glycemic status has not been successfully optimized despite on regular follow up of recruiting clinic for atleast 6 months and 4 clinical visits
  • c)>= 7.5% to any degree of hyperglycemia, if on multiple dose insulin for >= 6 months and glycemic status has not been successfully optimized, despite on regular follow up of recruiting clinic for atleast 6 months and 4 clinical visits
  • 5 Eligibility on basis of patient health questionnaire-9 (PHQ-9)Patients with mild to moderate depression (PHQ-9 score from 5-14) are eligible. Details of PHQ-9 are given ahead.

排除标准

  • 1 Terminal illness
  • 2 Known case of cancer
  • 3 Nephropathy with CKD stage 4 and 5
  • 4 Severe Non proliferative diabetic retinopathy, proliferative diabetic retinopathy, or macular edema
  • 5 Any cardiovascular event requiring hospitalization in last 6 months
  • 6 Active diabetic foot ulcer
  • 7 Hospitalization for more than 24 hours within one month or 2 such episodes in last 6 months
  • 8 Any death of first degree relative in last 6 months
  • 9 PHQ-9 score < 5 or > 14
  • 10 Suicidal thoughts nearly everyday i.e score of 3 for question 9 of PHQ-9 questionnaire
  • 11 Patients with dementia (Montreal cognitive assessment or MOCA score < 19

研究者

发起方
Applied for funding to Department of Science and Technology Delhi

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