| 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.
|