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
|
|
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
|
|
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 |