CTRI Number |
CTRI/2020/05/025398 [Registered on: 28/05/2020] Trial Registered Prospectively |
Last Modified On: |
22/07/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Preventive |
Study Design |
Single Arm Trial |
Public Title of Study
|
Study to find out the results of Ayurvedic Kwath & Ashwagandha churna with Yoga exercises to prevent our health workers against corona virus infection. |
Scientific Title of Study
|
Efficacy of Kiratiktadi Kwath & Ashwagandha churna with Yoga modalities in
prevention of infection against COVID -19 in Front line Health care workers
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
No |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prof Dr Ankur Singhal |
Designation |
Professor, Department Of Kayachikitsa, |
Affiliation |
GS Ayurveda Medical College and Hospital, Pilkhuwa |
Address |
GS AYURVEDA MEDICAL COLLEGE & HOSPITAL,
NH-9,
POST-PILKHUWA
DISTRICT- HAPUR
PIN-245304
Ghaziabad UTTAR PRADESH 245304 India |
Phone |
09760768689 |
Fax |
|
Email |
drankursinghal2015@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Dr Ankur Singhal |
Designation |
Professor, Department Of Kayachikitsa, |
Affiliation |
GS Ayurveda Medical College & Hospital, Pilkhuwa |
Address |
GS AYURVEDA MEDICAL COLLEGE & HOSPITAL, PILKHUWA
Ghaziabad UTTAR PRADESH 245304 India |
Phone |
09760768689 |
Fax |
|
Email |
drankursinghal2015@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Prof Dr Ankur Singhal |
Designation |
Professor, Department Of Kayachikitsa, |
Affiliation |
GS Ayurveda Medical College & Hospital, Pilkhuwa |
Address |
GS AYURVEDA MEDICAL COLLEGE & HOSPITAL,
POST-PILKHUWA
DISTRICT-HAPUR
Ghaziabad UTTAR PRADESH 245304 India |
Phone |
09760768689 |
Fax |
|
Email |
drankursinghal2015@gmail.com |
|
Source of Monetary or Material Support
|
MANAGING DIRECTOR, GS AYURVEDA MEDICAL COLLEGE & HOSPITAL,PILKHUWA,HAPUR -245304 |
|
Primary Sponsor
|
Name |
NO |
Address |
NIL |
Type of Sponsor |
Other [no] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Ankur Singhal |
GS Ayurveda Medical College & Hospital |
DEPARTMENT OF KAYACHIKITSA, GS AYURVEDA MEDICAL COLLEGE & HOSPITAL, NH-9, Near Pilkhuwa Railway Station, Pilkhuwa , District-Hapur
Ghaziabad UTTAR PRADESH |
09760768689
drankursinghal2015@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
HEALTHY |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
1) Kiratiktadi Kwath(Astadashang Kwath) for 14 days
2) Ashwgandha churna for 14 days
3) Yoga Modalities for 45 minutres |
1) Kiratiktadi Kwath (Astadashang Kwath) 30 ml twice a day empty stomach.ref-Sharangdhar Samhita -kwath prakaran - for 14 days
2)Ashwgandha churna 5gm with Milk Before sleep. for 14 days
3) Yoga modalities for 45 min twice a day empty stomach |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Inclusive criteria
Asymptomatic healthy cases appointed as front line health care workers.
Age above 20 yrs or below 60 yrs of either sex.
|
|
ExclusionCriteria |
Details |
Exclusive Criteria
Cases suffering from any co morbidities.
Age below 20 or above 60 yrs
Cases those are symptomatic to COVID-19 before study.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1) Efficacy of Kiratiktadi Kwath & Ashwagandha Churna with Yoga modalities in boosting Vyadhikshamatwa and prevention against communicable diseases.
2) Will help in overcoming the anxiety level and stress of healthcare workers.
|
4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Will help in overcoming the anxiety level and stress of healthcare workers. |
4 weeks |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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
|
N/A |
Date of First Enrollment (India)
|
28/05/2020 |
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
|
Years="0" Months="0" Days="30" |
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
|
This research has been proposed to assess the efficacy of Kiratiktadi Kwath & Ashwagandha churna with Yoga modalities in Health care workers taking care of COVID-19 patients.
|