CTRI Number	CTRI/2020/06/026151 [Registered on: 25/06/2020] Trial Registered Prospectively
Last Modified On:	08/03/2024
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Ayurveda Yoga & Naturopathy
Study Design	Randomized, Parallel Group Trial
Public Title of Study	Ayurveda and Yoga trial for preventing COVID 19 among healthcare workers
Scientific Title of Study	Evaluation of the prophylactic effect of Comprehensive Ayurveda and Mindfulness-based Yoga regimen among health care workers (HCW) of a tertiary care hospital in Delhi during COVID 19 Pandemic: a randomized controlled trial
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Gautam Sharma   Address  Center for Integrative medicine and Research, 7th floor, Convergence block, All India Institute of Medical Sciences, New Delhi South DELHI 110029 India  Phone  01126549325   Fax     Email  cimraiimsdelhi@gmail.com
Details Contact Person Scientific Query	Name  Dr Gautam Sharma   Address  Center for Integrative medicine and Research, 7th floor, Convergence block, All India Institute of Medical Sciences, New Delhi South DELHI 110029 India  Phone  01126549325   Fax     Email  cimraiimsdelhi@gmail.com
Details Contact Person Public Query	Name  Dr Gautam Sharma   Address  Center for Integrative medicine and Research, 7th floor, Convergence block, All India Institute of Medical Sciences, New Delhi South DELHI 110029 India  Phone  01126549325   Fax     Email  cimraiimsdelhi@gmail.com
Source of Monetary or Material Support	All India Institute of Medical Sciences, New Delhi  NA
Primary Sponsor	Name  infrastructural facility of All India Institute of Medical Sciences New Delhi  Address  CIMR, All India Institute of Medical Sciences  Type of Sponsor  Government funding agency
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Gautam Sharma  All India Institute of Medical Sciences, New Delhi  Room No 7004, Centre for Integrative Medicine and Research, 7th floor, Convergence Block, All India Institute of Medical sciences, New Delhi South   01126549325 cimraiimsdelhi@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  healthcare workers working in a tertiary care hospital
Intervention / Comparator Agent	Type  Name  Details  Intervention  comprehensive Ayurveda and Mindfulness based Yoga module   The participants in the intervention group will receive comprehensive Ayurveda and yoga regimen/therapy which will be administered for 12 weeks following recruitment into the trial. (1)Ayurveda Intervention includes: a. Tab Samshamani Vati 250 mg 2 tablet BD b. Tab Kalamegha tablet 250 mg BD (2) Yoga Therapy: The yoga practices will be taught by the institutionally qualified yoga therapists. There will be 5 online initial sessions which will be taught in the first week following recruitment and weekly once in the following weeks. A total of 16 online sessions will be conducted. The patients will be advised to practice yoga everyday (at least 5 days a week) for 12 weeks. Video of the complete session and picture based modules will be given, which will be free from the influence of education. A log book will be given to all recruited participants to follow their practice at home including duration and time of practice, additional physical activities, and intake of medications.   Comparator Agent  standard Prophylactic measures   Standard prophylactic mneasures prescribed by All India Institute of Medical Sciences, New Delhi
Inclusion Criteria	Age From  18.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  a. Aged 18-60 years b. Both genders c. AIIMS employee from any department(OPD/IPD) with risk of exposure to COVID-19 cases d. No history of symptoms attributable to COVID-19 or any acute respiratory illness e. Willingness and ability to comply with trial and follow-up procedures. f. Ability to understand the nature of the trial and give written/e-consent informed consent
ExclusionCriteria	Details  a. Suspected or confirmed current COVID-19, as determined by treating physician b. Pregnant or Nursing women c. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. d. Any other condition which the investigators feels, may interfere with the study outcomes
Method of Generating Random Sequence	Stratified randomization
Method of Concealment	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  Incidence of confirmed COVID-19 positive cases detection in experimental arm compared to control   Baseline, 8th week, 12th Week
Secondary Outcome	Outcome  TimePoints  a. Psychological distress among HCWs by using General Anxiety Disorder (GAD) and Patient Heath Questionnaire 9 (PHQ-9) b. Quality of Life among HWCs using short form 36 Questionnaire c. Routine Biochemical investigations such as CBC, Absolute Blood Count, Absolute neutrophil count, Absolute Lymphocyte count, LFT, KFT   Baseline, and end of 12th Week
Target Sample Size	Total Sample Size="452" Sample Size from India="452"
Phase of Trial	Phase 2
Date of First Enrollment (India)	10/06/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	not yet published
Brief Summary	The current study will be a Open label parallel Randomized controlled trial with two assessment point i.e. Baseline and 12 weeks. Healthcare workers from All India Institute of Medical Sciences, New Delhi would be recruited as participants for the trial. The consenting subjects would be randomly divided into two groups with an allocation ratio of 1:1, i.e. Intervention and control arm. The intervention arm participants will be administered a comprehensive Ayurveda and Mindfulness Yoga module. However participants from both arms would be allowed to follow the prophylactic measures. The Ayurveda medicines (Samshamani vati, Kalmegha tablets) and Mindfulness Yoga ( )module (is developed by experts of Ayurveda and Yoga along with discussion with multidisciplinary team at Center for Integrative Medicine and Research (CIMR) for prophylaxis of COVID19. The study will be conducted by the Center for Integrative Medicine and Research, AIIMS, New Delhi. The sample size will be 226 in each group is being considered. The trial is expected to be completed within one year.