| CTRI Number |
CTRI/2020/06/025861 [Registered on: 14/06/2020] Trial Registered Prospectively |
| Last Modified On: |
11/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
Scientific evaluation of Immuno-modulatory effects of AYUSH INTERVENTIONS on normal healthy and high-risk individuals in context with COVID-19 pandemic: An open level study |
Scientific Title of Study
Modification(s)
|
Scientific evaluation of Immuno-modulatory effects of AYUSH INTERVENTIONS on normal healthy and high-risk individuals in context with COVID-19 pandemic: An open level, multi centric, non-randomized, comparative, interventional community based study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avnish Kumar Upadhyay |
| Designation |
Medical Officer In-charge |
| Affiliation |
Department of Ayurvedic and Unani Services Uttarakhand |
| Address |
State Ayurvedic Hospital Pipali Block Kanalichhina
Pithoragarh
UTTARANCHAL
262541
India |
| Phone |
9639017857 |
| Fax |
|
| Email |
avnishdr@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Krishna Kant Pandey |
| Designation |
Medical Officer |
| Affiliation |
Department of Ayurvedic and Unani Services Uttarakhand |
| Address |
Ground Floor Directorate of Ayurvedic and Unani Services Danda Lakhaund Near IT Park
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9634465557 |
| Fax |
|
| Email |
kkpandey.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alok Kumar Shukla |
| Designation |
Medical Officer In-charge |
| Affiliation |
Department of Ayurvedic and Unani Services Uttarakhand |
| Address |
State Ayurvedic Hospital Mahuakheraganj Industrial Area Kashipur
Udham Singh Nagar
UTTARANCHAL
244713
India |
| Phone |
09927001514 |
| Fax |
|
| Email |
alokhema2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ayurvedic and Unani Services |
|
|
Primary Sponsor
|
| Name |
Department of Ayush Uttarakhand |
| Address |
Department of Ayurvedic and Unani Services
UTTARAKHAND, DEHRADUN
|
| Type of Sponsor |
Other [Government Organization running various hospital establishments] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| District Ayurvedic and Unani Office |
District Headquarters Uttarakhand |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Kumar |
Institutional Quarantine/ COVID Care Centre Almora |
MOIC, State Ayurvedic Hospital Saula Po-Daudakhal Block Tarikhet
Almora
UTTARANCHAL |
9456781360
05962237994
sandeepguptamp@gmail.com |
| Dr Sunil Kumar Raturi |
Institutional Quarantine/ COVID Care Centre Chamoli |
District Hospital (Ayush Wing) Gopeshwar Chamoli-246401
Chamoli
UTTARANCHAL |
9412413536
raturidr.sunil@gmail.com |
| Dr Saroj Kumar Mishra |
Institutional Quarantine/ COVID Care Centre Champawat |
State Ayurvedic Dispensary Main Market Lohaghat Tanakpur Pithoragarh National Highway
Champawat
UTTARANCHAL |
9580217247
mishradocsaroj432117@gmail.com |
| Dr Krishna Kant Pandey |
Institutional Quarantine/ COVID Care Centre Dehradun |
Directorate of Ayurvedic and Unani Services Danda Lakhaund Near IT Park
Dehradun
UTTARANCHAL |
9634465557
01352608760
ayurved83@gmail.com |
| Dr Jaideep Singh Bisht |
Institutional Quarantine/ COVID Care Centre Garhwal |
State Ayurvedic Hospital and Panchkarma Center Kotdwar Main Market Block Kotdwar
Garhwal
UTTARANCHAL |
9837634396
bishtdrjaideep@gmail.com |
| Dr Swastik Suresh |
Institutional Quarantine/ COVID Care Centre Haridwar |
State Ayurvedic Hospital Dhandeki Dhana Block Laksar Haridwar
Hardwar
UTTARANCHAL |
8899964888
drswastiksuresh@gmail.com |
| Dr Pankaj Kumar |
Institutional Quarantine/ COVID Care Centre Nainital |
Additional Primary Health Centre Ayush Wing Daulatpur Golapar Haldwani
Nainital
UTTARANCHAL |
9719865775
ajeejverma@gmail.com |
| Dr Deshraj Singh |
Institutional Quarantine/ COVID Care Centre Pithoragarh |
State Ayurvedic Hospital Jajurali Block Vid
Pithoragarh
UTTARANCHAL |
9411151690
drs28drs@gmail.com |
| Dr Ashok Kumar Tiwari |
Institutional Quarantine/ COVID Care Centre Rudraprayag |
State Ayurvedic Dispensary Kherikhal PO Ghandiyalka 246171
Rudraprayag
UTTARANCHAL |
8392925080
drashokt22@gmail.com |
| Dr Rakesh Kumar Agarwal |
Institutional Quarantine/ COVID Care Centre Tehri |
State Allopathic Dispensary (Ayush Wing) Akhori Po-Ghansali, Block- Bhilangana Tehri Garhwal
Tehri Garhwal
UTTARANCHAL |
8006279589
pypayurveda@gmail.com |
| Dr Alok Kumar Shukla |
Institutional Quarantine/ COVID Care Centre US Nagar |
State Ayurvedic Hospiral Mahuakheda Ganj Kashipur
Udham Singh Nagar
UTTARANCHAL |
9927001514
alokhema2@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers in high risk for having COVID-19 infected. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AYUSH INTERVENSION - Treatment Protocol - I: |
Ayush Raksha Kwath 10 gms (A.P.I.)
Luke warm decoction of of kwath churna twice daily 30 minute before breakfast and dinner
Ashwagandha Vati: 500 mg (A.P.I.)
1 tablet administered twice 30 minute before breakfast and dinner with luke warm water
Sanshmani Vaati: 500 mg (S.Y.S.)
1 tablet administered twice 30 minute before breakfast and dinner with luke warm water |
| Intervention |
AYUSH INTERVENTION - Treatment Protocol - II: |
Ashwagandha Churna (A.P.I.) + Madhyashti Churna (A.P.I.)
1 gram powder of each twice daily 30 minute before breakfast and dinner with luke warm water
Amritadi Guggul 500 mg (A.F.I.)
2 tablets administered twice 30 minute before breakfast and dinner with luke warm water |
| Intervention |
AYUSH INTERVENTION - Treatment Protocol - III: |
Pippali Churna (A.P.I.) + Madhyashti Churna (A.P.I.)
1 gram powder of each twice daily 30 minute before breakfast and dinner with luke warm water
Amritadi Guggul 500 mg (A.F.I.)
2 tablets administered twice 30 minute before breakfast and dinner with luke warm water |
| Intervention |
AYUSH INTERVENTION - Treatment Protocol - IV: |
Shunthi Churna (A.P.I.) + Madhyashti Churna (A.P.I.) + Pippalimool Churna (A.P.I.)
500 mg powder of each twice daily 30 minute before breakfast and dinner with luke warm water
Amritadi Guggul 500 mg (A.F.I.)
2 tablets administered twice 30 minute before breakfast and dinner with luke warm water |
| Intervention |
AYUSH INTERVENTION - Treatment Protocol - V: |
Ashwagandha Churna (A.P.I.) + Madhyashti Churna (A.P.I.) + Shunthi Churna (A.P.I.)
500 mg powder of each twice daily 30 minute before breakfast and dinner with luke warm water
Amritadi Guggul 500 mg (A.F.I.)
2 tablets administered twice 30 minute before breakfast and dinner with luke warm water |
| Intervention |
AYUSH INTERVENTION - Treatment Protocol - VI: |
Ashwagandha Churna (A.P.I.)
2 gram powder twice daily 30 minute before breakfast and dinner with luke warm water
Amritadi Guggul 500 mg (A.F.I.)
2 tablets administered twice 30 minute before breakfast and dinner with luke warm water
Anu Taila (Nasya Therapy) (A.F.I.)
4 drops of Anu Taila put in each nostril 60 minute before breakfast every morning |
| Comparator Agent |
Luke warm water |
Subjects not willing to use interventional drugs/ Luke warm water |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female > 18 and < 75 years of age (inclusive).
2. The normal healthy individuals.
3. High risk individuals.
4. Immunosuppressant peoples and subjects with mild to moderate co-morbidities.
5. Non-symptomatic subjects under Institutional and Home Quarantine.
6. Symptomatic subjects under Institutional Quarantine. (Optional, subject to approval from concerned officials and departments)
7. Confirmed COVID-19 cases under isolation and treatment (Optional, subject to approval from concerned officials and departments)
8. Signed ICF
|
|
| ExclusionCriteria |
| Details |
1. Subjects < 18 and > 75 years of age
2. Uncontrolled systemic illness.
3. Hypersensitivity to any component of Investigational Drug.
4. Recent history of drug or alcohol abuse.
5. Pregnant female.
6. Pre-existing GI symptoms like nausea and vomiting.
7. Patients not willing to sign ICF.
8. Individuals with severe co-morbidities.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
i. Clinical, psychological and Quality of life assessment
ii. Comparative analysis of occurrence of COVID-19 in subjects taking Ayurvedic Interventions and those not taking Ayurvedic Intervention
iii. Comparative analysis of occurrence of conclusive symptoms of COVID-19 (as per ordinal scale of clinical improvement published by WHO).
iv. Comparative analysis of occurrence of conclusive symptoms of other than non-COVID-19 |
From baseline assessment, 1 week, 2 week and 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assesment of laboratory parameters Rapid ELISA COVID 19, PCR COVID 19, Viral Load, T.L.C. D.L.C; Hb% ; E.S.R. ; P.P.B.S., URINE : RE / ME etc.
Incidence of COVID 19 infection in during study period in study population
Requirement of treatment for symptoms developed, if any during trial period |
From screening assessment till the end of two weeks |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/06/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
It is well known that COVID-19 infection influences immunosuppressive people more harshly. Thusly, improving insusceptibility is unquestionably one of the manners in which the specialists over the globe have been utilizing for treating COVID-19 cases. Truth be told, high portions of vitamin C, known to support immunity, have been regulated to the COVID-19 patients in China and other countries with promising outcomes. Indian Council of Medical Research (ICMR) also endorsed the utilization of hydroxyl-chloroquinone for prophylactic treatment of COVID-19 positive cases as of late on March 26, 2020.
Ayurveda makes reference to various resistances boosting therapeutics, one of the incredibly Indian customary medications. The study objectives are the scientific evaluation of Immuno-modulatory effects of AYUSH INTERVENTIONS on normal healthy and high-risk individuals in context with COVID-19 pandemic. |