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CTRI Number  CTRI/2021/02/031036 [Registered on: 05/02/2021] Trial Registered Prospectively
Last Modified On: 04/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study
Modification(s)  
Effect of Gayatri Mantra and Pranayama on covid-19 patients. 
Scientific Title of Study
Modification(s)  
A pilot study to see effect of gayatri mantra and pranayama in terms of inflammatory markers in hospitalized covid-19 patients. 
Secondary IDs if Any  
Secondary ID  Registry 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  DrRuchi Dua  
Address  Level-6,Dept-Pulmonary Medicine, AIIMS RISHIKESH
AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India 
Phone  7895973469  
Fax    
Email  ruchi.pulm@aiimsrishikesh.edu.in  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  DrRuchi Dua  
Address  Level-6,Dept-Pulmonary Medicine, AIIMS RISHIKESH
AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India 
Phone  7895973469  
Fax    
Email  ruchi.pulm@aiimsrishikesh.edu.in  
 
Details Contact Person
Public Query

Modification(s)  
Name  DrRuchi Dua  
Address  Level-6,Dept-Pulmonary Medicine, AIIMS RISHIKESH
AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India 
Phone  7895973469  
Fax    
Email  ruchi.pulm@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support
Modification(s)  
Department of Science & Technology (DST),Government of India, Technology bhavan,New Mehraulli Road,New Delhi-110016 
 
Primary Sponsor  
Name  Department of Science Technology DST  
Address  Technology Bhavan, New Mehrauli Road, Block C, Qutab Institutional Area, New Delhi, Delhi 110016 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
nil   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
DrRuchi Dua  AIIMS RISHIKESH   level-6 Covid Ward,AIIMS RISHIKESH
Dehradun
 
7895973469

ruchi.pulm@aiimsrishikesh.edu.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS RISIKESH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Coronavirus as the cause of diseases classified elsewhere 
Patients  Other viral pneumonia 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Gayatri Mantra chanting and pranayama along with usual treatment   Intervention will be given by a certified Yoga instructor and usual treatment by qualified doctors Gayatri mantra chanting and pranayama instruction will be given by video-conferencing /Google meet. Patients will perform Regular 1-hour gayatri mantra chant and pranayama in the morning and in the evening in the hospitalized room or at home after discharge up to 14 days. Intervention Video and pictures based on how to do Gayatri mantra and pranayama will be shared with covid-19 patients. We will check haematological investigations/CXR at baseline and time of discharge/14th day Questionnaires for Quality of Life (SGRQ)8, Depression/Anxiety (PHQ-99 & GAD-7)10 & Fatigue Scale will be administered at baseline and at 14th day telephonically. Time for symptom abatement /cure by RT PCR will be recorded along with final outcomes & Total Duration of hospital stay by a questionnaire along with demographic data. Google diary/ google meet to check adherence in intervention arm will be used. 
Comparator Agent  usual treatment  Control group will be given usual treatment by qualified doctors for 14 days. We will check haematological investigations/CXR at baseline and time of discharge/14th day QLF, depression/anxiety & Fatigue Scale will be administered at 14th day telephonically Time for symptom abatement /cure by RT PCR will be recorded along with final outcomes & Total Duration of hospital stay by a questionnaire along with demographic data. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Consenting
18-70 years, either sex
Diagnosed case of Covid-19 based on RT PCR, hospitalized at AIIMS Rishikesh covid centre in moderate symptom category as per ICMR guidelines (dyspnea/hypoxia with saturation<94% on room air/Respiratory rate >24breaths/minute)8
Having a smartphone and internet facility and able to use it
Serum procalcitonin <0.5 ng/ml 
 
ExclusionCriteria 
Details  Non-consenting/critical category as per
ICMR guidelines1

Patients in ICU or on mechanical
ventilation/continuous NIV or Fio2>.40

Patients unable to perform Pranakarshan
Pranayama/Gayatri Mantra

Patients with known psychiatric or
COPD/CLD/CRF/BA/diabetics(HbA1c>7),se
vere HT, malignancy,IBD,CAD.

Pregnant/lactating females 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
hs C-Reactive protein (highly sensitive CRP)  baseline,at time of discharge/14 days  
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1.Inflammatory markers
Interleukin 6(IL6) levels
lactate dehydrogenase(LDH)
Serum Ferritin
D-DIMER
Erythrocyte sedimentation rate (ESR)
Complete blood counts (CBC)
2.Radiological –Improvement on Chest x-rays (CXR)
3.Clinical Improvement-Time to symptom abatement /Time when declared cured by negative swab on RT PCR will be recorded
4.Total Duration of hospital stay
5.Final Outcome-discharged/ Died/worsened
6.(SGRQ)
7. (PHQ-9) d(GAD-7)
8.Fatigue scores  
baseline,at time of discharge/14 days  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  
10/02/2021 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil  
Brief Summary  

Corona virus caused by SARS-CoV2 is one of the major viruses that primarily targets the human respiratory system. The Gayatri Mantra is the most sacred prayer of the Hindus. There is no effective treatment or vaccine for this virus as yet. Scientists are racing against time for a miracle cure/vaccine to fight this pandemic which has gripped the world. In this scenario role of  pranayama and Gayatri mantra chanting which has been used in other diseases and has shown promising effects becomes vital.

 

 

Aim: -

To compare effectiveness of 14 days’ series of Gayatri Mantra and pranayama in addition to usual treatment and usual treatment alone in terms of Inflammatory Markers in diagnosed hospitalized patients of Covid-19.

Design: - A Pilot study

Setting/Location: - Covid centre AIIMS RISHIKESH

Subjects: - 20

Interventions: - A Pilot study will be conducted on 20 hospitalized moderate symptom8 category Covid-19 patients. The subjects will be recruited from covid centre at All India Institute of Medical Sciences, Rishikesh (AIIMS). Patients will be allocated to two groups: Group A (Intervention group), Group B (Control group).

Patients in Group A (Intervention arm) will perform Gayatri mantra and Pranayama till 14 days along with usual treatment. Patient’s in Group B (Control arm) will be Given Usual Treatment till 14days.

 

Outcome Measures: -hs C-Reactive protein (highly sensitive CRP) as the primary outcome.

©  Secondary outcomes

1.Inflammatory markers

· Interleukin 6(IL6) levels

· lactate dehydrogenase(LDH)

· Serum Ferritin

· D-DIMER

· Erythrocyte sedimentation rate (ESR)

· Complete blood counts (CBC)

2.Radiological –Improvement on Chest x-rays (CXR)

3.Clinical Improvement-Time to symptom abatement /Time when declared cured by negative swab on RT PCR will be recorded

4.Total Duration of hospital stay

5.Final Outcome-discharged/ Died/worsened

6.Health related quality of life- by St. George’s Respiratory Questionnaire (SGRQ)

7.Anxiety & depression scores -Patient Health Questionnaire-9 (PHQ-9) for depression and generalized anxiety disorder-7(GAD-7) for anxiety

8.Fatigue scores- Fatigue  Scale 

 

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