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
|
|
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
|
|
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 , “AyurCoro3â€
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 . |