| CTRI Number |
CTRI/2020/06/026262 [Registered on: 30/06/2020] Trial Registered Prospectively |
| Last Modified On: |
07/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Single Center,Study on Evaluation of use of,“AYURCOV†as add on therapy for Treatment of SARS-CoV-2 Infection in COVID-19 Patients,at Tertiary Care Center. |
Scientific Title of Study
Modification(s)
|
Prospective , single center ,open label, randomized controlled , pilot study on evaluation of use of , “AYURCOV†as an adjuvant for treatment purpose in treatment of SARS-CoV-2 infection for covid-19 patients , at tertiary care center. |
| Trial Acronym |
AYURCOV |
|
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 of the Department Ayurveda |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
Department of Ayurveda,Bhaktivedanta Hospital and Research Institute Srishti Complex Bhaktivedanta Swami Marg Mira Road East Thane
Thane
MAHARASHTRA
401107
India |
| Phone |
08767271628 |
| Fax |
|
| Email |
drmemane@bhaktivedantahospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaykumar Gawali |
| Designation |
Head of the Department - Clinical Research |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
Medical Research Dept,Bhaktivedanta Hospital and Research Institute Srishti Complex Bhaktivedanta Swami Marg Mira Road East Thane
Thane
MAHARASHTRA
401107
India |
| Phone |
09320199122 |
| Fax |
9320199122 |
| Email |
drvijaykumar@bhaktivedantahospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nanasaheb Memane |
| Designation |
Head of the Department Ayurveda |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
Department of Ayurveda ,Bhaktivedanta Hospital and Research Institute Srishti Complex Bhaktivedanta Swami Marg Mira Road East Thane
Thane
MAHARASHTRA
401107
India |
| Phone |
08767271628 |
| Fax |
|
| Email |
drmemane@bhaktivedantahospital.com |
|
|
Source of Monetary or Material Support
|
| Clinical Administration Dept ,Bhaktivedanta Hospital and Research Institute , Mira Road , Thane 401107 |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research Institute |
| Address |
Srishti Complex Bhaktivedanta Swami Marg Mira Road East Thane |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
Department of Ayurveda ,Bhaktivedanta Hospital and Research Institute |
Srishti Complex Bhaktivedanta Swami Marg Mira Road East Thane
Thane
MAHARASHTRA |
08767271628
drmemane@bhaktivedantahospital.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committee |
Approved |
| 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, (2) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AYURCOV |
Following study medication is for one day
Investigational Product Gargle 2 times a day for one day
Investigational Product in half glass of warm water, to drink every 2 hours, 3 times a day This need to be started 1 hour post lunch After 1 hour of completing the last dose drink 1 glass of pure bos indicus milk with two tea spoon of Go Ghrut
Investigational Product 2 tablets twice for one day
|
| Comparator Agent |
Standard of care treatment |
COVID 19 Treatment as per government guideline. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. COVID -19 Positive patients
2. Agree to consent for the study.
3. All Age groups above 18 Years
4. All genders.
|
|
| ExclusionCriteria |
| Details |
1. Unable to be followed-up during the trial
2. Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies) .
3. Any other clinical reason which may preclude entry in the opinion of the investigator.
4, Pregnant Women.
5. Patients who are on ventilator support .
|
|
|
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 |
| COVID 19 FREE DISEASE |
AT TIME OF DISCHARGE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SEVERITY OF COVID 19 DISEASE |
DURING HOSPITALIZATION AND AT TIME OF DISCHARGE |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2020 |
| Date of Study Completion (India) |
29/10/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Prospective
, single center ,open label, randomized controlled , pilot study on evaluation of use of ,
“AYURCOV†as an adjuvant for treatment
purpose in treatment of SARS-CoV-2 infection for 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 . | Study Participants Distribution ( By Randomization technique ) | | Group | Group Criteria Definition | Standard of care and Ayurcov | Only Standard of care | | 1 | COVID -19 Positive patients (Mild and Moderate Cases) | 45 | 45 | | 2 | COVID -19 Positive patients (Severe Cases ) | 15 | 15 | |
| | | | 1. Mild to Moderate Covid-19 Patients: Non-pneumonia and mild pneumonia 2. Severe Covid-19 Patients : Dyspnea, respiratory frequency ≥ 30/min, blood oxygen saturation (SpO2) ≤ 93%, PaO2/FiO2 ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours . Duration of the study participation is 1 month. As mentioned in the chart above there are four groups in the study . Every group is further divided in 2 subgroups of which one group will get standard of care and Ayurcov and another group will get only standard of care. Study doctor will participants medical records to study, effect of study drug on participant disease . Study doctor will examine study participants during your hospital stay to observe for any side effects . Study doctor will follow up telephonically 1 week post discharge to enquire study participants about their health status .
|