| CTRI Number |
CTRI/2020/05/024986 [Registered on: 04/05/2020] Trial Registered Prospectively |
| Last Modified On: |
04/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
HOMOEOPATHY IN PREVENTION OF COVID-19 |
|
Scientific Title of Study
|
EFFECTIVENESS OF ARSENICUM ALBUM 30C IN PREVENTION OF COVID-19 IN INDIVIDUALS RESIDING IN HOSPOTS OF RED ZONES IN DELHI– A PROSPECTIVE COHORT STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer/Scientist-II |
| Affiliation |
CCRH |
| Address |
Room no 303
61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
South West
DELHI
110058
India |
| Phone |
09873404012 |
| Fax |
|
| Email |
drdnayak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Khurana |
| Designation |
Director General Incharge |
| Affiliation |
CCRH |
| Address |
Room No-408
61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
South West
DELHI
110058
India |
| Phone |
09911127619 |
| Fax |
|
| Email |
anil23101961@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raj K Manchanda |
| Designation |
Director AYUSH |
| Affiliation |
DIRECTORATE OF AYUSH |
| Address |
Ayurvedic & Unani Tibbia College Campus, Karol Bagh, New Delhi 110005
New Delhi
DELHI
110005
India |
| Phone |
9811014493 |
| Fax |
|
| Email |
rkmanchanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New
Delhi, Delhi 110058 61-65, Opp D Block, Institutional
Area, Janakpuri, New Delhi, Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Debadatta Nayak |
Hot spots of Covid -19 in Delhi |
Central Council for Research in Homoeopathy
61-65, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
South West
DELHI |
09873404012
drdnayak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-CCRH |
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 |
Homoeopathic Medicine |
Homoeopathic medicine Arsenic album 30c will be given to population residing in hot spots of Red zones of Covid-19 out break. The medicine will be given as medicated globules. 2-4 medicated globules will be given twice daily for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
• Suspected cases of Covid 19 infection who
are asymptomatic
• Persons residing in residing in hot spots
of Delhi.
• Age 1 year & above
• Both gender
• Willing to give verbal informed consent (keeping in view
contagious nature of disease)
|
|
| ExclusionCriteria |
| Details |
• Pregnant women
• Lactating mothers
• Immunocompromised individuals on basis of
medical history
• Symptomatic (similar to COVID-19) cases
at quarantine zone.
• Not willing to give verbal informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Confirmation of diagnosis for COVID-19 infection / end of quarantine period as per standard protocol. |
Every 7th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare time to appearance of clinical symptoms of
COVID-19 infections.
• To compare time to confirmation of diagnosis for COVID-19
(Laboratory findings)
|
Every 7th day. |
|
|
Target Sample Size
|
Total Sample Size="10000"
Sample Size from India="10000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/05/2020 |
| Date of Study Completion (India) |
30/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Accepted for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The results of the study will be able
to estimate the protective effect of Arsenicum album in COVID 19
prevention. If found effective, this could prove to be a vital contribution in
public health care for a disease with high mortality. Further the
cost-effectiveness of homoeopathy will enable developing countries in
controlling such deadly disease effectively.
|