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CTRI Number  CTRI/2020/05/025341 [Registered on: 24/05/2020] Trial Registered Prospectively
Last Modified On: 22/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to know the effect of Ayurvedic Kwath(Kiratiktadi Kwath) & Ashwagandha Churna along with yoga exercises in the treatment of COVID-19 Positive patients. 
Scientific Title of Study   Efficacy of Kiratiktadi Kwath & Ashwagandha Churna with Yoga modalities in management of COVID -19 patients.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankur Singhal 
Designation  Professor, Department Of Kayachikitsa, 
Affiliation  GS Ayurveda Medical College & Hospital, Pilkhuwa 
Address  Department of Kayachikitsa, GS Ayurveda Medical College & Hospital, NH-9, NEAR RAILWAY STATION, POST-PILKHUWA DISTRICT- HAPUR

Ghaziabad
UTTAR PRADESH
245304
India 
Phone  09760768689  
Fax    
Email  drankursinghal2015@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ankur Singhal 
Designation  Professor, Department Of Kayachikitsa, 
Affiliation  GS Ayurveda Medical College & Hospital, Pilkhuwa 
Address  Department of Kayachikitsa, GS Ayurveda Medical College & Hospital, NH-9, NEAR RAILWAY STATION, POST-PILKHUWA DISTRICT- HAPUR

Ghaziabad
UTTAR PRADESH
245304
India 
Phone  09760768689  
Fax    
Email  drankursinghal2015@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ankur Singhal 
Designation  Professor, Department Of Kayachikitsa, 
Affiliation  GS Ayurveda Medical College & Hospital, Pilkhuwa 
Address  Department of Kayachikitsa, GS Ayurveda Medical College & Hospital, NH-9, NEAR RAILWAY STATION, POST-PILKHUWA DISTRICT- HAPUR

Ghaziabad
UTTAR PRADESH
245304
India 
Phone  09760768689  
Fax    
Email  drankursinghal2015@gmail.com  
 
Source of Monetary or Material Support  
Mrs. Sonali Sharma, The Managing Director GS Ayurveda Medical College & Hospital, Pilkhuwa District-Hapur 
 
Primary Sponsor  
Name  NO 
Address  NIL 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NO  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  GS Ayurveda Medical College & Hospital, NH-9, Near Railway Station, Post-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 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere, B342||Coronavirus infection, unspecified, B338||Other specified viral diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1) Kiratiktadi Kwath 30 ml twice a day before food for 14 days. 2)Ashwagandha churna 5gm before sleep with luke warm water. for 14 days 3) Yoga exercises 45 min twice a day empty stomach for 14 days. 4)Immunobooster Ayush Kwath as ministry of ayush guidlines 40 ml once a day (early morning , empty stomach)  1) Kiratiktadi Kwath as mentioned in sharngdhar samhita in kwath prakaran. 2) Aswagandha churna as mentioned in rasayan adhikar in chakradatt tika. 3) Yoga exercises including pranayam, suryanamaskar etc. as per MDNIY, NEW DELHI 
Comparator Agent  MODERN TREATMENT as per UP Govt Norms to asymptomatic and mild cases.  MODERN TREATMENT as per UP Govt Norms to asymptomatic and mild cases. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) COVID 19 positive cases with mild symptoms or Asymptomatic
2) Age: above 20 yrs or below 60 yrs of either sex.
 
 
ExclusionCriteria 
Details  1) Cases suffering from any co morbidities.
2) Age below 20 or above 60 yrs
COVID -19 negative cases.
3) If the patient develops any systemic side effects.
Symptoms of COVID-19 aggravated to moderate level during study.
4) Moderate and Severe patients of COVID-19 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Kiratiktadi Kwath & Ashwagandha Churna with yoga modalities in the management of mild and asymptomatic cases of COVID-19 Patients  approx 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Rate of recovery with ayurvedic management as compared to modern treatment.  approx 12 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)   02/06/2020 
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   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   no 
Brief Summary   EFFICACY OF KIRATIKTADI KWATH & ASHWAGANDHA CHURNA WITH YOGA MODALITIES IN THE MANAGEMENT OF COVID-19 PATIENTS.
Management  includes:
Guggulu dhoopan twice a day in COVID-19 wards.
Ayush Kadha as herbal tea once a day early morning.
Yoga sessions twice a day.
Kirtikatdi kwath 30 ml twice a day.
Ashwagandha churna 5gm once a day with lukewarm water.
Specific diet plan.
 
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