| CTRI Number |
CTRI/2020/05/025205 [Registered on: 15/05/2020] Trial Registered Prospectively |
| Last Modified On: |
20/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Arsenicum album – 30 as prophylactic for Covid-19 |
|
Scientific Title of Study
|
Effectiveness of Arsenicum Album 30c in Prevention of Covid-19 in Individuals Residing in Hot Spots of Red Zones– A Multicentric, Randomised, Cluster Level, Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Khurana |
| Designation |
Director General |
| 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
Scientific Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer/Scientist-II |
| Affiliation |
CCRH |
| Address |
Epidemic Cell
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
Public Query
|
| Name |
Dr Debadatta Nayak |
| Designation |
Research Officer/Scientist-II |
| Affiliation |
CCRH |
| Address |
Epidemic cell, 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 |
|
|
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 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karthikeyan |
Hot spots of Covid -19 in Chennai |
Homoeopathy Research Institute for Disabilities, 136,NIEPMD Campus
East Coast Road, Muttukadu, Chennai 603112
Chennai
TAMIL NADU |
8281488685
drkarthikeyanmd@gmail.com |
| Dr Debadatta Nayak |
Hot spots of Covid -19 in Delhi |
61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
South West
DELHI |
09873404012
drdnayak@gmail.com |
| Dr Ch Ravender |
Hot spots of Covid -19 in Gudivada and Vijaywada |
Regional Research Institute for (Homoeopathy)
Dr. GGH Medical College Campus, Eluru Road, Gudivada – 521 301
Krishna Dist., Andhra Pradesh State Mob.
Krishna
ANDHRA PRADESH |
9849126380
rrigudivada@gmail.com |
| Dr P Hima Bindu |
Hot spots of Covid -19 in Hyderabad |
Standardisation Unit (Homoeopathy),
OUB-32, Street No. 4, Habsiguda, Hyderabad, Tellangana-500007
Hyderabad
TELANGANA |
9490009899
drdewdrop@gmail.com |
| Dr Ashish Mahajan |
Hot spots of Covid -19 in Jaipur |
Central Research Institute (Homoeopathy), Sector 26, Pratap Nagar, Jaipur
Jaipur
RAJASTHAN |
8527266606
dr.aashishmahajan@gmail.com |
| Dr P P Pal |
Hot spots of Covid -19 in Kolkata |
Dr. Anjali Chatterji Regional Research In Homoeopathy 50, Rajendra Chatterjee Road, Kolkata-700035
Kolkata
WEST BENGAL |
8910890779
justdoit.partha@gmail.com |
| Dr KC Murleedharan |
Hot spots of Covid -19 in Kottayam |
National Homoeopathy Research Institute in Mental Health
Sachivothamapuram P.O., Kottayam-686 532(Kerala)
Kottayam
KERALA |
9869321223
nhrimh@gmail.com |
| Dr Lipipushpa Debata |
Hot spots of Covid -19 in Lucknow |
Homoeopathic Drug Research Institute
National Homoeopathic Medical College & Hospital, 1 Viraj Khand, Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH |
07755014040
drlipi08@gmail.com |
| Dr Ramesh Bawaskar |
Hot spots of Covid -19 in Mumbai |
Regional Research Institute (Homoeopathy), Hall no. 4, Shopping centre, Sector-9, CBD, Belapur, Navi Mumbai-400614
Mumbai
MAHARASHTRA |
9769888743
drbrsb@gmail.com |
| Dr Subhash Kaushik |
Hot spots of Covid -19 in Noida |
Dr. D. P. Rastogi Central Research Institute of Homoeopathy
A-1/1, Sector 24, NOIDA, Gautambudh Nagar, 201301 (U.P.)
Gautam Buddha Nagar
UTTAR PRADESH |
9810788976
subhashccrh@gmail.com |
| Dr Vipul R Shatri |
Hot spots of Covid -19 in Surat |
C.D.Pachchigar Homoeopathic Medical College,
Bhatar Road, Nr. Anand Mangal Society,
SURAT - 395001
Surat
GUJARAT |
09824109174
drvipulshastri@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-CCRH |
Approved |
| Institutional Ethics Committee-CDPCHM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
For prophylaxis of COVID-19 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arsenicum album 30C |
The Arsenicum album 30C will be given to the high risk contact of COVID 19 cases and residing in hotspots of containment zone. The 4 pills of medicine will be given orally twice daily for 7 days. |
| Comparator Agent |
No intervention. |
The control group clusters will receive no tretment. However the will be under observation similar to medicine group. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
• High risk contacts of Covid 19 infection who are asymptomatic and residing in hotspots.
• Age 1 year & above
• Both gender
• Willing to give verbal informed consent or written informed consent as the situation may be (keeping in view contagious nature of disease)
|
|
| ExclusionCriteria |
| Details |
• Pregnant women or lactating mothers
• Immunocompromised individuals on basis of medical history.
• Symptomatic (similar to COVID-19) cases at quarantine zone.
• Not willing to give informed consent/verbal consent.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Confirmation of diagnosis for COVID-19 infection based on RT-PCR / end of quarantine period as per standard protocol. |
Every third day till 21st day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the asymptomatic/symptomatic Covid-19 positive cases between the groups.
2. To compare time to appearance of clinical symptoms of COVID-19 infections.
3. To compare time to confirmation of diagnosis for COVID-19 (Laboratory findings)
|
Every third day till 21st day. |
|
|
Target Sample Size
|
Total Sample Size="33000"
Sample Size from India="33000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/05/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
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 prophylactic effect of Arsenicum album 30C 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.
|