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临床试验/CTRI/2025/10/095639
CTRI/2025/10/095639尚未招募不适用

To Study impact of 12 weeks of Bhramari Pranayama on serum nitric oxide levels, changes in cardio-pulmonary functions, and wound healing in adults with Type 2 Diabetic Mellitus.

Swami Rama Himalayan University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2025年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
94
试验地点
1
主要终点
Serum Nitric Oxide(NO), Respiratory Function, Cardiovascular function and wound healing

研究概览

简要总结

This Single-Blinded, Parallel-Group Randomized Controlled Trial aims to evaluate the impact of a yoga-based intervention, Bhramari Pranayama, on ulcer wound healing, as well as cardiovascular and pulmonary health, in patients with Type 2 Diabetes Mellitus. Eligible patients presenting with diabetic ulcers will be recruited from the Department of Surgery, Himalayan Hospital, Dehradun, India. Participants in the intervention arm will receive a 12-week structured Bhramari Pranayama program, while both the intervention and control groups will continue to receive standard allopathic treatment. The Outcomes will be assessed using the Leg Ulcer Measurement Tool (LUMT) for wound healing, Doppler Ultrasound for vascular function, Heart Rate Variability (HRV) for cardiovascular health, Spirometry for pulmonary function, and Serum Nitric Oxide (NO) Levels to evaluate underlying physiological mechanisms. This study is expected to provide evidence on the effectiveness of Bhramari Pranayama as a complementary therapy for improving wound healing and overall health in patients with Type 2 Diabetes Mellitus.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • Adults with diabetes mellitus type
  • Grade 1 ulcers as per wagner classification.
  • Hba1c levels greater than equal to 6.5.

排除标准

  • History of active ear infection, low blood pressure, or epilepsy 2) Severe respiratory disorders (acute or chronic), chest wall injuries/deformities 3) Congestive cardiac failure (CHF).

结局指标

主要结局

Serum Nitric Oxide(NO), Respiratory Function, Cardiovascular function and wound healing

时间窗: Serum Nitric Oxide- (0, 2, 6 and 12 weeks) Respiratory and Cardiovascular function (0, 6 and 12 weeks) and wound healing (0 and 12 weeks)

次要结局

  • Blood Flow and HRV(Blood Flow and HRV (0, 6 and 12 week))

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Yogesh Saxena

Swami Rama Himalayan University

研究点 (1)

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