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CTRI Number  CTRI/2020/05/025156 [Registered on: 13/05/2020] Trial Registered Prospectively
Last Modified On: 11/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Ayurveda intervention AYUSH-64 add-on therapy for patients with COVID-19 infection (Stage I) 
Scientific Title of Study   Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush-64) add-on therapy for patients with COVID-19 infection (Stage I)-A Randomized controlled clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Govind Reddy  
Designation  Asstt. Director (Ayu) Incharge  
Affiliation  Regional Ayurveda Research Institute for Mother and Child Health, Nagpur 
Address  Regional Ayurveda Research Institute for Mother and Child Health (RARIMCH) Near Gharkul Parisar Nandanvan Nagpur Maharashtra 440009

Nagpur
MAHARASHTRA
440009
India 
Phone  9820284671  
Fax    
Email  drrgreddy68@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr R Govind Reddy  
Designation  Asstt. Director (Ayu) Incharge  
Affiliation  Regional Ayurveda Research Institute for Mother and Child Health, Nagpur 
Address  Regional Ayurveda Research Institute for Mother and Child Health (RARIMCH) Near Gharkul Parisar Nandanvan Nagpur Maharashtra 440009

Nagpur
MAHARASHTRA
440009
India 
Phone  9820284671  
Fax    
Email  drrgreddy68@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr R Govind Reddy  
Designation  Asstt. Director (Ayu) Incharge  
Affiliation  Regional Ayurveda Research Institute for Mother and Child Health, Nagpur 
Address  Regional Ayurveda Research Institute for Mother and Child Health (RARIMCH) Near Gharkul Parisar Nandanvan Nagpur Maharashtra 440009

Nagpur
MAHARASHTRA
440009
India 
Phone  9820284671  
Fax    
Email  drrgreddy68@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, New Delhi-110058 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan 61-65, Institutional Area, Opposite D-Block, Janakpuri, New Delhi-110058.  
Type of Sponsor  Research institution and hospital 
 
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 Rajesh Vithal Gosavi   Government Medical College, Nagpur  Room no. 101, first floor, hospital building, Government Medical College Near Hanuman Nagar Nagpur- 440009.
Nagpur
MAHARASHTRA 
9820284671

gosavirv@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) Department of pharmacology, Govt. Medical College, Nagpur.   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 
Intervention  Group I: Ayurveda intervention AYUSH-64 as add-on to standard treament  AYUSH 64: 2 Tablets (500mg each) thrice daily with water after meal for 1 month 
Comparator Agent  Group II: Standard treatment for COVID-19 infection  Standard treatments for COVID-19 infection as per Maharashtra guidelines 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of 18-60 yrs of age, clinically diagnosed with corona virus disease 2019 by RTPCR test coming under stage I- mild (Early infection)- Group A, B, C as per TREATMENT PROTOCOL FOR CONFIRMED COVID-19 PATIENTS (Maharashtra Health Services_15 April 2020.)
2.Participants who can take medicines orally.
3.Patients willing to provide signed informed consent.
 
 
ExclusionCriteria 
Details  1.Pregnant, Lactating women, patients with CKD (Chronic Kidney Disease).
2.Not willing to participate in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Clinical cure rate: Time to negative conversion of severe acute respiratory syndrome corona-virus 2.  At baseline, 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Duration of fever and each of the respiratory symptoms.
2.Improvement in hematological and laboratory parameters (CBC, LFT, RFT, RBS, ESR, Hs-CRP, LDH, CXR, ABG, S. Ferritin, D-dimer, ECG).
3.No of cases Reporting any ADR/AE.
4.Number of patients referred.
5.Number of cases that required invasive or non-invasive oxygen therapy during the intervention.
6.Number of cases that progressed to multi-organ failure while under clinical trial.  
1 Month 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   18/05/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The trial results will be published by CCRAS at the end of clinical trial. 
Brief Summary  
Central council for research in Ayurvedic sciences has undertaken the clinical collaborative project with Government Medical College, Nagpur to assess the Efficacy and Safety of Ayurveda Intervention (Ayush-64) as add-on therapy for patients with COVID-19 infection (Stage I) at Nagpur District, Maharashtra. In this study,  Total 60  patients of 18-60 yrs of age, clinically diagnosed with corona virus disease 2019 by RTPCR test coming under stage I- mild (Early infection)- Group A, B, C as per TREATMENT PROTOCOL FOR CONFIRMED COVID-19 PATIENTS (Maharashtra Health Services_15 April 2020.) will be selected from Government Medical College, Nagpur and randomly divided in 2 groups having 30 patients each. Group I (30 Patients) will receive Ayurveda intervention AYUSH-64 as add-on to standard treatment as per guidelines. The dose of AYUSH -64 will be 2 Tablets (500mg each) thrice daily after meal for 1 month. Group II (30 Patients) will receive standard treatment for COVID-19 infection as per Maharashtra guidelines. Patients will be reviewed on 7th, 15th, 22th and 30th day after their inclusion in trial. Assessment of effects of the therapy will be done on the basis of various subjective and objective criteria. Any change in sign and symptom will be noted. Laboratory investigation will be done as per the group of the stage I of COVID-19 infection. After completion of the trial, data will be analyzed using appropriate statistical tests and the result will be documented.  
 
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