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CTRI Number  CTRI/2020/10/028333 [Registered on: 09/10/2020] Trial Registered Prospectively
Last Modified On: 09/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Prospective on evaluation of use of , “AyurCoro3” as an add on medication for the treatment purpose in COVID-19 patients 
Scientific Title of Study   Prospective , multi center ,single blind , randomized controlled study on evaluation of use of , “AyurCoro3” as an adjuvant for the treatment purpose in mild to moderate COVID-19 patients at tertiary care center. 
Trial Acronym  AyurCoro3 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nanasaheb Memane 
Designation  Head - Ayurveda Dept 
Affiliation  Bhaktivedanta Hospital and Research Institute  
Address  Department of Ayurveda , Ground Floor, srishti sector 1 , Bhaktivedanta Swami Marg , Thane , Mira Road
Department of Ayurveda , Ground Floor, srishti sector 1 , Bhaktivedanta Swami Marg , Thane , Mira Road
Thane
MAHARASHTRA
401107
India 
Phone  8767271628  
Fax    
Email  drmemane@bhaktivedantahospital.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijaykumar Gawali 
Designation  Head - Clinical Research & Education 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  Department of Research , 5th Floor, srishti sector 1 , Bhaktivedanta Swami Marg , Thane , Mira Road
Department of Research , 5th Floor, srishti sector 1 , Bhaktivedanta Swami Marg , Thane , Mira Road
Thane
MAHARASHTRA
401107
India 
Phone  9320199122  
Fax    
Email  drvijaykumar@bhaktivedantahospital.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vijaykumar Gawali 
Designation  Head - Clinical Research & Education 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  Department of Research , 5th Floor, srishti sector 1 , Bhaktivedanta Swami Marg , Thane , Mira Road
Department of Research , 5th Floor, srishti sector 1 , Bhaktivedanta Swami Marg , Thane , Mira Road
Thane
MAHARASHTRA
401107
India 
Phone  9320199122  
Fax    
Email  drvijaykumar@bhaktivedantahospital.com  
 
Source of Monetary or Material Support  
Shri Sarveshwar Seva Samstha 
 
Primary Sponsor  
Name  Shri Sarveshwar Seva Sahkari Samstha 
Address  Kurla , Mumbai 400070 
Type of Sponsor  Other [Seva Trust] 
 
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 Nanasaheb Memane   Bhaktivedanta Hospital and Research Institute   Department of Ayurveda ,Ground Floor ,Srishti sector 1 , Bhaktivedanta Swami Marg
Thane
MAHARASHTRA 
8767271628

drmemane@bhaktivedantahospital.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BhaktiVedanta Hospital Ethics Committee for Biomedical and Health Research  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  AyurCov3  10 Ml three times a day for 3 days . One day medication 
Comparator Agent  Standard of care  As per routine clinical care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Laboratory confirmed diagnosis of Mild to Moderate COVID-19 patients
2. Agree to consent for the study.
3. All Age groups above 18 Years
4. All genders.
 
 
ExclusionCriteria 
Details  1. Patients on ventilator
2. Critically ill patient
3. Dyspnea, respiratory frequency ≥ 30/min,
4. Blood oxygen saturation (SpO2) ≤ 90%,
5. PaO2/FiO2 ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours
6. Patients with altered mental state
7. Patients with multiple organ failure requiring ICU monitoring and treatment.
8. Patients with respiratory failure and requiring mechanical ventilation/
9. Patient who have participated in another investigational study within 3 months prior to enrollment in this study
10. Investigators, study personnel and their first-degree relatives.
11. Pregnant Patients
12. Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies).
13. Any other clinical reason which may preclude entry in the opinion of the investigator.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time (Days) to clinical improvement from study enrolment   At Baseline, Day three , Day five and Day seven 
 
Secondary Outcome  
Outcome  TimePoints 
1. Clinical status as assessed by the 9-point ordinal scale
2. Duration of hospitalization
3. Proportion of participants in each group with need for mechanical ventilation
4. Rate of patients showing improvement of 2 points in 7 category ordinal scale
5. Functional status scale -post covid-19 at 1 week post discharge Follow up visit
 
At Baseline, Day three , Day five and Day seven and at Discharge 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "174"
Final Enrollment numbers achieved (India)="174" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   13/10/2020 
Date of Study Completion (India) 26/02/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   No 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Prospective , single center ,single blinded, randomized controlled  study on evaluation of use of , “AyurCoro3” as an adjuvant  for the treatment purpose in mild to moderate COVID-19 patients at tertiary care center.Study procedures shall be initiated post obtaining written informed consent process, as per local regulatory requirements. Randomization of the groups would be done as per computer generated charts , details of the randomization are as per below mentioned chart.  Randomization chart is enclosed along with the protocol for reference .

 

The participants were randomly allotted in the ratio 1:1 using a computer-generated random-number list to either the ’Control Arm’ (‘Standard of  Care’) or the ’Intervention Arm’ (Study  Medicine as an adjuvant to ’Standard of Care’). A total of 500 Patients would be randomized,250 in Control and 250 in Interventions. The participants wont not incur any personal cost owing to the study .

The randomization sequence with a size of 4 was generated by a statistician who was not part of the study team. Eligible patients are allocated to receive medication, according to the sequential order. Envelopes are prepared for emergency unmasking. Laboratory technicians are blinded to treatment allocation. The evaluators and statisticians are blinded until the completion of the visit and analysis. Data validation, cleaning and statistical analysis are done by trial researchers in collaboration with the Indian Institute of Technology Bombay (IIT Bombay), India. A Dedicated Research Coordinator who had no involvement in the participant enrollment,  would be doing the random allocation. ". After ensuring eligibility of patients, a Dedicated Research Coordinator would communicate the  assigned treatment to the recruiting investigator.

Study doctor will follow up telephonically 1 week post discharge to enquire study participants about their health status for functional status scale -post covid-19  .

 
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