FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/06/026231 [Registered on: 29/06/2020] Trial Registered Prospectively
Last Modified On: 29/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study effect of ayurvedic treatment for prevention and management of asymptomatic, mild and moderate cases of COVID-19. 
Scientific Title of Study   “To study the efficacy of add on Ayurvedic treatment to the standard of care for prevention and management of asymptomatic, mild & moderate cases of COVID-19.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajkumar Nikalje 
Designation  Assistant Professor 
Affiliation  Symbiosis Medical College for Women and symbiosis university hospital and research centre 
Address  Department of Respiratory medicine, 5th floor, symbiosis medical college for women and symbiosis university hospital and research centre, Lavale hill base, Gram: Lavale, Tal: Mulshi Dist:Pune

Pune
MAHARASHTRA
412115
India 
Phone  9028560535  
Fax    
Email  nikalje.rajkumar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyoti Shirodkar 
Designation  Ayurvedic Physician 
Affiliation  Symbiosis medical college for women and symbiosis university hospital and research centre, pune 
Address  c/o Dr. Shirodkars Health Solutions PL, S2/11, Devideep Society, NDA Road, Bavdhan, Pune 411021

Pune
MAHARASHTRA
411021
India 
Phone  9822352497  
Fax    
Email  drjyotishirodkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyoti Shirodkar 
Designation  Ayurvedic Physician 
Affiliation  Symbiosis medical college for women and symbiosis university hospital and research centre, pune 
Address  c/o Dr. Shirodkars Health Solutions PL, S2/11, Devideep Society, NDA Road, Bavdhan, Pune 411021

Pune
MAHARASHTRA
411021
India 
Phone  9822352497  
Fax    
Email  drjyotishirodkar@gmail.com  
 
Source of Monetary or Material Support  
Symbiosis medical college for women and symbiosis university hospital and research centre, Lavale, pune  
 
Primary Sponsor  
Name  Ministry of AYUSH 
Address  Ayush Bhawan, B Block, Gpo Complex, Ina, New Delhi, Delhi 110023 
Type of Sponsor  Government funding agency 
 
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 Vijay Natarajan  Symbiosis University Hospital and Research Centre  Department of respiratory medicine, 5th floor, Symbiosis medical college for women, Lavale Hill base, Gram-Lavale, Tal-Mulshi, Pune Pin-412115
Pune
MAHARASHTRA 
9822251686

vijaynatarajan5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics committee, symbiosis international university  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  For prevention regime-Standard of care  Standard of care as per hospital protocol 
Intervention  For Prevention regime: Ayurvedic treatment  1.Dietary recommendations and restrictions 2.Morning, empty stomach: 4 black resins boiled in one cupful of water 3.Decoction of cinnamon, dried ginger, black pepper and cardamom at 9.00 am 4.A cup of hot milk with 250 mg-500 mg of turmeric powder, 2 hours after dinner. 5.Sanshamanivati 250-500mg twice a day with water. 
Intervention  For Treatment regime- Ayurvedic treatment   1.Tab TribhuvanKirti: 125mg-250mg + Tab. Sutshekhar: 250 mg+ SitopaladiChurna : 500 mg (Thrice a day with hot water for 14 days). 2.Samshamanivati 250-500 mg, (twice a day with hot water) 3.If dry cough is present, shunthiksheerpak will be given for 5-7 days in addition to above treatment. After this treatment, patients will be given the Ayurvedic regime prescribed for prevention regime for 28 days. 
Comparator Agent  For treatment regime- standard of care   standard of care as per hospital protocol 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Males or Females with age group of 18 years to 60 years.
Participants, ready to sign informed consent form
For Prevention Regime: Health care workers working in Hospital and are Negative for
COVID-19 test.
For treatment Regime: Asymptomatic, mild & moderate laboratory confirmed cases
of COVID-19 
 
ExclusionCriteria 
Details  1.Age below 18 years and above 60 years
2.Pregnant and lactating women
3. Seriously ill patients requiring intensive care
4 Subjects who have participated in another investigational drug or research study
within 30 days of screening. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of Ayurvedic treatment on eradication of virus by testing for SARS-Co-V-2 by Real time PCR test
 
Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in inflammatory markers   Day 1, 5, 10
 
Resolution of signs and symptoms of COVID-19   day 3, 5, 10
 
Duration of hospitalisation   actual number of days of hospitalisation
 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   15/07/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary  
In view of current outbreak of COVID-19 and lack of proven treatment in modern science, it
is necessary to look for an alternative treatment. We propose add on Ayurvedic therapy for
prevention of COVID-19 in COVID negative health care workers (n=50) and asymptomatic,
mild and moderate COVID Positive cases (n=30). This is a proof of concept study.
Participants of the study will be randomized in two arms: A. standard of care alone B.
standard of care + Ayurvedic management. The outcomes of Ayurvedic treatment will be
compared with allopathic standard of care in the same number of patients. So the study will
be carried out in total 160 participants (100 COVID negative health care workers and 60
COVID positive cases). Prevention regime includes decoction of common spices, turmeric
with milk, samshamani vati (tinospora cordifolia formulation) and black resins with hot water
for 28 days. Management regime includes a combination of Tribhuvan kirti, sutshekhar and
sitopaladi churna along with sanshamani vati for 14 days. This will be followed by
prevention regime of 28 days. Pre-trial and post-trial COVID-19 antibodies, Hemogram, and
inflammatory markers like ferritin, CRP will be compared. The analysis will be done to
confirm the effectiveness of Ayurvedic medicine in preventing the health care workers from
getting COVID-19 infection and for treatment of asymptomatic, mild & moderate Covid-19
positive cases.
 
Close