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临床试验/CTRI/2020/10/028486
CTRI/2020/10/028486已完成1 期

EFFICACY OF INTEGRATED YOGA INTERVENTION ON PHYSIOLOGICAL AND PSYCHOLOGICAL OUTCOMES OF COVID-19 PATIENTS WITH MILD SYMPTOMS

Pragya Jain Shrimal1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年2月11日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Oxygen Saturation, Heart Rate, Respiratory Rate and Blood pressure

研究概览

简要总结

COVID-19 is an infectious disease caused by recently discovered novel coronavirus (World Health Organization, 2020a). Coronaviruses are a large family of viruses which may cause illness in animals or humans. In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) (National Health Mission, 2020). The most recently discovered coronavirus causes coronavirus disease COVID-19 (World Health Organization, 2020).

As per WHO, COVID-19 has affected 215 countries or territories or areas. Till 16th July 2020, there have been infected over 12,015,193 people of COVID-19, including 549,247 deaths reported Globally (World Health Organization, 2020c). In India, COVID-19 has been infected 974,737 people in which 331146active cases, 612814 recovery  and has claimed 24915 deaths, as per the Ministry of Health and Family Welfare, Government of India (Ministry of Health and Family Welfare, 2020).

Yoga as an add-on therapy may support patients of COVID-19 by improving the quality of standard care (Tillu et al., 2020).The Health advisory is given by The Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH) against coronavirus infection included Practice of  Yogasana, Pranayama and meditation for at least 30 minutes every day for immunity-boosting guidelines to supplement the fight against COVID-19 (Ayush Ministry, 2020). The Harvard Medical School in the US has recommended yoga, meditation and controlled breathing to address anxiety issues related to the novel coronavirus (Sharp, 2020). Yoga is an add ’on benefits of stress management, as well as prevention and management of chronic non communicable diseases and communicable diseases. Based on the available scientific evidences on yoga in improving respiratory and immune functions. (Nagarathna et al., 2020). Certain meditation, yoga asana (postures), and pranayama (breathing) practices may possibly be effective adjunctive means of treating and/or preventing SARS-CoV-2 infection (Bushell et al., 2020).                                                                    Hence there is a requirement of such a study which provides integrated yoga based intervention in the scenario of COVID-19 pandemic. So this will be the study which is going to see the effect of short term yogic intervention on COVID-19 patients with symptoms.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Only COVID-19 positives confirmed by RT-PCR method to be recruited.
  • •Patients who are affected by the coronavirus (COVID-19) and are in hospital confinement.
  • •Patients with mild symptoms which may include: uncomplicated upper respiratory tract viral infection symptoms such as fever, fatigue, cough (with or without sputum production), anorexia, malaise, muscle pain, sore throat, dyspnoea, nasal congestion, or headache.
  • •Inclusion of symptomatic patients.

排除标准

  • •Unwilling for participation.
  • •Physical and mental disability.
  • •Medical restriction for physical movement.
  • •History of recent surgery.
  • •Patients with Pneumonia, Acute Respiratory Distress Syndrome (ARDS) & patients admitted in Intensive Care Units (ICU).
  • •Pregnant females.
  • •Patients with severe co-morbid conditions (Congestive Heart failure, Uncontrolled Diabetes, Renal failure on hemodialysis, Cancer patients).

结局指标

主要结局

Oxygen Saturation, Heart Rate, Respiratory Rate and Blood pressure

时间窗: Day 5th and Day 6th

次要结局

  • Stress, Anxiety and Mindfulness(Day 5th and Day 6th)

研究者

发起方
Pragya Jain Shrimal
申办方类型
Other [Self Funding]

研究点 (1)

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