| CTRI Number |
CTRI/2020/06/025558 [Registered on: 02/06/2020] Trial Registered Prospectively |
| Last Modified On: |
02/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic Medicines Bryonia alba 30C as a Prophylaxis for COVID-19 |
|
Scientific Title of Study
|
Effectiveness of Bryonia Alba 30C in the prevention of COVID-19 in Quarantine individual: Double Blind, Randomised Placebo Controlled Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Prof Dr Puneet R Shah |
| Address |
Department of physiology, First Floor, Aarogya Homoeopathic Medical College and Hospital, Shri Vinayak Education Campus, Naila, Near Kanota, Agra Road, Jaipur
Aarogya Homoeopathic Medical College and Hospital, Shri Vinayak Education Campus, Naila, Near Kanota, Agra Road, J
Jaipur
RAJASTHAN
303012
India |
| Phone |
9983666775 |
| Fax |
|
| Email |
svspseducation@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Dan Singh Meena |
| Address |
Aarogya Homoeopathic Medical College and Hospital, Shri Vinayak Education Campus, Naila, Near Kanota, Agra Road, Jaipur
Aarogya Homoeopathic Medical College and Hospital, Shri Vinayak Education Campus, Naila, Near Kanota, Agra Road, J
Jaipur
RAJASTHAN
303012
India |
| Phone |
9636452755 |
| Fax |
|
| Email |
drdannih@gmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Prof Dr Puneet R Shah |
| Address |
Aarogya Homoeopathic Medical College and Hospital, Shri Vinayak Education Campus, Naila, Near Kanota, Agra Road, Jaipur
Aarogya Homoeopathic Medical College and Hospital, Shri Vinayak Education Campus, Naila, Near Kanota, Agra Road, J
Jaipur
RAJASTHAN
303012
India |
| Phone |
9983666775 |
| Fax |
|
| Email |
svspseducation@gmail.com |
|
|
Source of Monetary or Material Support
|
| Designed Quarantine centres for COVID-19 with approval of Authorities. |
|
|
Primary Sponsor
|
| Name |
Principal Aarogya Homoeopathic Medical College and Hospital |
| Address |
Shri Vinayak Education Campus, Naila, Near Kanota, Agra Road, Jaipur-303012 (Rajasthan) |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ministry of AYUSH |
Under Secretary (EMR), Ministry of AYUSH, New Delhi-
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Puneet R Shah |
Designed Quarantine centres for COVID-19 with approval of Authorities. |
Jaipur District, Rajasthan
Jaipur
|
9636268373
svspseducation@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Coronavirus as the cause of diseases classified elsewhere |
| Patients |
Other specified viral diseases |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Bryonia alba 30C |
Another half or 50 percentage of cases will receive Bryonia alba 30C as experiment arm.
Homoeopathy intervention shall be taken twice (6 pills) daily of prescribed Homoeopathic medicine, on empty stomach for seven days along with usual standard care of IPC. |
| Comparator Agent |
Identical Placebo |
Placebo shall be taken twice (6 pills) daily on empty stomach for seven days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Persons in Quarantine centres with history of exposure, with all the following shall be included:
1. Suspected cases of COVID-19 who are asymptomatic.
2. Age 18 years and above and all genders
3. Willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women or lactating mothers
2. Immunocompromised individuals on basis of medical history
3. Symptomatic (similar to COVID-19) cases at quarantine facility.
4. Rapidly progressive respiratory failure and sepsis.
5. Aged below 18 yrs
6. Not willing to give informed consent
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The results of the study will be able to determine the prophylactic effect of Homoeopathic Medicines in COVId-19 cases. If found effective, this could prove to be a Vital contribution in public health care for this Global Crisis of COVID-19. |
1 week |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Further, the cost-effectiveness of Homeopathy will enable developing countries in controlling such deadly disease effectively. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
15/06/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication of Results in a Peer-reviewed scientific journal or presentation at a scientific Congress. |
|
Brief Summary
|
Principal Investigator, Aarogya Homoeopathic Medical College & Hospital, Naila, Jaipur has proposed to carry out a clinical trial entitled “Effectiveness of Bryonia Alba 30C in the prevention of COVID-19 in Quarantine individual: Double Blind, Randomised Placebo Controlled Trial”. Presently, Threr is no Prophylaxis, antivirals and Vaccines available in the market for the treatment and prevention against Corona virus, the proposal of which is yet to be approved. All above said facts prompted to take up in this project. Quarantine individuals are the population, who has exposure to the cases and are at risk of developing the COVID-19 disease. Therefore, protective effect of any medication can be evaluated on these populations. Keeping in view the clinical success of Homoeopathy in SARS-Cov-2 & COVID-19 infection and evaluation of Genus epidemicus, in absence of any solution against COVID-19, there is merit to explore Bryonia Alba 30C as a prophylactic in COVID-19 at Quarantined individuals. General Hygienic precaution related to management, fixed diet regimen and instructions about exercise will be given to all the patients of both groups. Also the instruction about exercise will be given to all of them. After the completion of study, it will be evaluate on the basis of Subjective Criteria. The proposed treatment and regimen is designed to add efficacy of Homoeopathic Prophylactic Bryonia alba 30C indicating overall aims of the research, importance of the objectives and their application in the context of the priority for the prophylactic management and immuno stimulation system created in infected patient’s body. In the wake of the COVID-19 outbreak, entire mankind across the globe is suffering. Enhancing the body’s natural defence system plays an important role in maintaining optimum health and the efficacy of the above prophylactic management by Bryonia alba 30C will be determined through comparing the occurrence of COVID-19 in general condition where the Homoeopathic management not given to the individuals who are present in Quarantine centres. |
