| CTRI Number |
CTRI/2020/06/026056 [Registered on: 23/06/2020] Trial Registered Prospectively |
| Last Modified On: |
23/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
An interventional study to access the effect of Homoeopathic medicine Arsenicum album 30 C as a prohylaxis in high risk population exposed to COVID-19. |
Scientific Title of Study
Modification(s)
|
A prospective interventional study on the effect of Arsenicum album 30 C as a prophylactic measure among High risk population exposed to COVID-19. |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Prof PK Goswami |
| Address |
Office of the Director
Department of Samhita and Sanskrit
Mawdiangdiang
near police outpost
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
9415385128 |
| Fax |
|
| Email |
pkgoswamibhu@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Tapan Nath |
| Address |
Department of Case Taking and
Repertory
College of Homoeopathy
Room no 24 NEIAH
Mawdiangdiang
near police outpost
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
8837349308 |
| Fax |
|
| Email |
tapanbngn@gmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Tapan Nath |
| Address |
Department of Case Taking and
Repertory
College of Homoeopathy
Room no 24 NEIAH
Mawdiangdiang
near police outpost
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
8837349308 |
| Fax |
|
| Email |
tapanbngn@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Ministry of AYUSH
AYUSH BHAWAN B Block GPO Complex INA New Delhi 110023 |
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH |
| Address |
AYUSH Bhawan
B BLOCK
GPO Complex
INA
New Delhi 110023 |
| Type of Sponsor |
Other [Union Ministry Governmnet of India] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr P K Goswami |
North Eastern Institute of Ayurveda and Homoeopathy |
Office of Director
Mawdiangdiang Shillong
793018
East Khasi Hills
|
9415385128
pkgoswamibhu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-NEIAH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
High Risk Population exposed to COVID-19 |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Arsenicum album 30 C |
Arsenicum album 30 C
Once Daily for 3 consecutive days early morning in empty stomach.
One adult dose is 5 globules of no. 30 medicated globule
One child dose is 3 globules of no. 30 medicated globule |
| Comparator Agent |
Placebo |
Number 30 sugar gloubles will be used as placebo in the control arm |
|
Inclusion Criteria
Modification(s)
|
| Age From |
3.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of high risk population.
2. Male or female subjects above the age of 03 years to 65 years.
3. Subject who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and Lactating woman.
2. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening.
3. Subjects who are on any other regular medication( Alternative/ Modern)for any other ailments.
4. Subjects participating in any other clinical study or having participated in any other study one month prior to screening in the present study.
5. Subjects having a past history of allergy to any medicine that is part of the Homoeopathic
intervention. Other conditions, which in the opinion of the investigators, makes the patient
unsuitable for enrolment or could interfere with his participation in, and completion of the protocol. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess of occurrence of COVID-19 infection in healthy volunteers exposed to COVID-19 in the community |
6 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. To assess the immunity status of the participants taking Arsenicum album -30 C
2. To evaluate the occurance of advarse event for safety assessment of Arsenicum album-30C. |
6 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="5000"
Sample Size from India="5000" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
26/06/2020 |
| 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
Modification(s)
|
NIL |
Brief Summary
Modification(s)
|
This study is a prospective non-randomized interventional trial to assess the effectiveness of Arsenicum album 30 C, 3 or 5 globules (child/adult dose respectively) once daily for three days as a prophylactic measure in 5000 participants of the high-risk population exposed to COVID-19 in one centre in India. The primary outcome will measure the assessment of the occurrence of COVID-19 infection in healthy volunteers and the secondary outcome will assess the immunity status of the participants taking the medicine Arsenicum album 30C. |
