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临床试验/CTRI/2025/01/078962
CTRI/2025/01/078962尚未招募不适用

Non Pharmacological Therapy (NPT consisting of Abhyangam and sunbathing, diversified diet, Pranayam and Yogasana) as an adjuvant in the management of COPD

ESIC Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Objective Outcome Parameters:

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality globally. Non-Pharmacological Therapies (NPT) can complement standard pharmacological treatments for COPD.  Abhyangam (a traditional Indian oil massage) improves circulation, reduces stress, enhances lung function, and promotes relaxation. Sunbathing provides vitamin D, which is crucial for bone health and immune function. Diversified diet ensures the intake of essential nutrients, supports overall health, and can reduce inflammation. Pranayam (breathing exercises) may enhance lung capacity, improve oxygenation, and promote relaxation. Yogasana improves flexibility, strengthens respiratory muscles, reduces stress, and enhances overall physical fitness. Such interventions focus on improving overall health, enhancing lung function, and alleviating symptoms through natural and holistic approaches. When used in conjunction with, not as replacement for conventional medical treatments, NPT potentially holds promise for a comprehensive management of COPD.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed cases of COPD.
  • Stage I, II and III COPD, clinically stable for at least 3 months.
  • Sufficient cognitive function to follow instructions for spirometry.
  • Able to walk without aid.
  • Willingness to undergo the prescribed modified lifestyle protocol of NPT
  • Provide informed consent.

排除标准

  • Exclusion 1.Myocardial infarction within last 3 months 2.Asthma 3.Recent surgery of thorax, abdomen, head, eyes or ear.
  • Haemoptysis.
  • 5.Severe hypertension (BP more than 200/120 mm Hg).
  • 6.Recurrent angina within the previous six months.
  • 7.Recent injury or neuromuscular conditions interfering with exercise tests.
  • 8.Current Smokers.
  • 9.Active Tuberculosis infection.

结局指标

主要结局

Objective Outcome Parameters:

时间窗: 12 weeks objective Outcome Parameters

1. The efficacy of the NPT regimen will be evaluated based on various objective measures, including vital signs such as blood pressure (BP), pulse rate (PR), respiratory rate (RR), and oxygen saturation (SpO2), as well as findings from chest examinations.

时间窗: 12 weeks objective Outcome Parameters

2. Pulmonary function tests, including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC ratio. We will assess lung functions using spirometry.

时间窗: 12 weeks objective Outcome Parameters

3. Laboratory investigations will monitor changes in complete blood count (CBC), liver function tests (LFT), kidney function tests (KFT), serum electrolyte levels, random blood sugar (RBS), high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), vitamin D levels, D-dimer, and lipid profile. In addition, the occurrence of respiratory infection will be evaluated to assess the impact of the intervention.

时间窗: 12 weeks objective Outcome Parameters

次要结局

  • Subjective Outcome Parameters(1. Subjective outcomes will focus on the patients perception of their COPD symptoms and overall well-being.)
  • 3. Mental health status will be evaluated using the WHO (Five) Well Being Index, while sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). These subjective measures will provide insights into the impact of the NPT regimen on symptom burden, functional status, mental health, and sleep disturbances experienced by COPD patients.(12 weeks)

研究者

发起方
ESIC Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Rakesh Sarwal

ESIC Medical College

研究点 (1)

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