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CTRI Number  CTRI/2020/09/027786 [Registered on: 14/09/2020] Trial Registered Prospectively
Last Modified On: 11/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic Management of Covid 19 patients 
Scientific Title of Study   Ayurvedic Management of asymptomatic & mild symptomatic covid 19 patients - A clinical and laboratory assesment 
Trial Acronym  AMC19 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J Clarence Davy  
Designation  Principal 
Affiliation  Government Ayurveda Medical College and Hospital,Kottar 
Address  Faculty Block, Govt Ayurveda Medical College and Hospital, Kottar, Nagercoil

Kanniyakumari
TAMIL NADU
629002
India 
Phone  09489284953  
Fax    
Email  ayurdavy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramaraju 
Designation  Reader,Dept of Swasthavritta 
Affiliation  Government Ayurveda Medical College and Hospital,Kottar 
Address  Faculty Block, Government Ayurveda Medical College and Hospital Kottar, Nagercoil

Kanniyakumari
TAMIL NADU
629002
India 
Phone  9751497841  
Fax    
Email  drrajumd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sunil Roy R 
Designation  Lecturer,Dept of Shalya Tantra 
Affiliation  Government Ayurveda Medical College and Hospital,Kottar 
Address  Faculty Block, Government Ayurveda Medical College and Hospital, Kottar, Nagercoil

Kanniyakumari
TAMIL NADU
629002
India 
Phone  9487552427  
Fax    
Email  sunilbams@gmail.com  
 
Source of Monetary or Material Support  
Directorate of Indian Directorate Of Indian Medicine and Homoeopathy, Arumbakkam, Chennai 600 106 
 
Primary Sponsor  
Name  Principal Secretary Health and Family welfar Govt of Tamilnadu 
Address  St.George Fort Chennai 600009 
Type of Sponsor  Government medical college 
 
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 J Clarence Davy  Government Ayurveda Medical College and Hospital,Kottar  IPD Block,GAMC Hospital, Kottar, Nagercoil. 629002
Kanniyakumari
TAMIL NADU 		 09489284953

ayurdavy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee,GAMCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayurveda Intervension Bharangyadi kashayam,Sudharshanavati,Guduchi paaneeyam,Thaleesadi choornam for 21 days  1.Bharangyadi kashayam Dose- 50ml with warm water before food 2.Sudharshanavati Dose -2 tab twice daily after food with warm water 3.Guduchi paaneeyam Dose – Whole day in place of water whenever patient feels thirsty 4.Thaleesadi choornam Dose-5gms mixed with honey and taken frequently in case of mild symptoms. For 21 days  
Comparator Agent  Control Group Standard treatment as per ICMR guidelines  Standard of care therapies as per the latest guidelines released by ICMR and Tamilnadu government. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -COVID-19 positive as determined by RT-PCR or
other approved commercial or public health
assay
-Informed consent for the study
-Asymptomatic stage
-mild stage (cough, fever)
-Respiratory rate < 24 per minute and oxygen
saturation > 94%
 
 
ExclusionCriteria 
Details  -Participation in any other clinical trial of
an experimental treatment for COVID-19
-Patients with severe COVID-19 disease defined
as follows respiratory distress,oxygen
saturation at rest ≤94%,severe disease
complications.
Pregnant women or women who are breastfeeding
-Immunocompromised patients taking (presently
on immunosuppressant medication any time
during last 90 days)
-Diabetics with >9% HbA1c
-Patients on antimicrobials, antibiotics,
antifungals during last 30 days
-Patients with active malignancy
-patients with bleeding disorders
-Pandu (Hb<7)
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To prevent covid19 postive cases in asymptomatic
and mild stages progressing into moderate and
severe stages assessed by clinical and laboratory
parameters and to find the time taken to
convert SARS‐CoV‐2 negative determined by RT-PCR.  		 Participants will be provided with study medication orally for 21 days, with close follow-up on weekly basis.
-Baseline
-7th day
-14th day
-21st day 
 
Secondary Outcome  
Outcome  TimePoints 
No of cases Reporting any ADR/AE assessed clinically and by laboratory parameters(CBC,CRP,LFT,urea,creatinine)  -Baseline
-7th day
-14th day
-21st day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/10/2020 
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 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
      COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is a global health crisis with a potential to produce a damage at social, economic, and political level. At present there is no approved treatment for Covid19. But the disease was highly contagious that it was transmitted to vast number of people in our country. Several studies have documented infection in patients who never developed the symptoms (Asymptomatic). Since the Asymptomatic persons are not routinely tested their prevalence to spread the infection seems to be more. Clinical laboratory finding in patients of severe Covid 19 positive suggest an immunopathology.Ayurveda mentioned about the epidemics/pandemic’s diseases under the concept of Janapadhodwamsa and infectious diseases under Sankramikaroga. Ayurvedic medicine has its own evidence in treating such infectious diseases of various causes since ages. This project is aimed to prove the efficacy of Ayurvedic management in treating the Positive Asymptomatic and mild cases of Covid19 clinically as well as in laboratory parameters.

In this study, Total 60 patients of 18-60 yrs of age, clinically diagnosed with COVID-19 by RT-PCR test who are asymptomatic or with mild symptoms were selected and randomly divided in 2 groups having 30 patients each. Group I (30 Patients) will receive Ayurveda intervention. Group II (30 Patients) will receive standard treatment for COVID-19 infection as per TN Government guidelines. Assessment of effects of the therapy will be done on the basis of various subjective and objective criteria. After completion of the trial, data will be analyzed using appropriate statistical tests and the result will be documented.  

 
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