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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
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.

 
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