| CTRI Number |
CTRI/2020/06/025844 [Registered on: 12/06/2020] Trial Registered Prospectively |
| Last Modified On: |
04/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Pre-Identified Homoeopathic Medicines In Asymptomatic Covid -19 Individuals Receiving Standard Treatment Protocol |
|
Scientific Title of Study
|
Comparative Effectiveness Of Pre-Identified Homoeopathic Medicines In Asymptomatic Covid -19 Individuals Receiving Standard Treatment Protocol–An Open Label, Randomised, Placebo 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 Varanasi Roja |
| Designation |
Research Officer (H)/Scientist-2 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Clinical Research
Room no. 317,
Clinical Research
Central Council for Research in Homoeopathy
61-65 Institutional Area, Janakpuri
South West
DELHI
110058
India |
| Phone |
9999454036 |
| Fax |
|
| Email |
varanasiroja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varanasi Roja |
| Designation |
Research Officer (H)/Scientist-2 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no. 317
Central Council for Research in Homoeopathy
61-65 Institutional Area, Janakpuri
South West
DELHI
110058
India |
| Phone |
9999454036 |
| Fax |
|
| Email |
varanasiroja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Khurana |
| Designation |
Director General In Charge |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no. 408
61-65 Institutional Area, Janakpuri
South West
DELHI
110058
India |
| Phone |
9911127619 |
| Fax |
|
| Email |
anil23101961@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 New Delhi |
| Address |
61-65, Institutional area, opp D block Janakpuri |
| 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 Sunita Tomar |
Government Homoeopathic Medical College and Hospital |
Room no. 2
Medical Superintendent
AYUSH Parisar, Kallusot Dam, MACT hills, pin 462003
Bhopal
MADHYA PRADESH |
826875470
dr.sunitatomar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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 |
Homoeoapthic medicine |
Arsenicum album 30- four pills twice daily for seven days, Bryonia 30- four pills twice daily for seven days, Camphora 1M- four pills twice daily for four days alongwith Standard treatment protocol |
| Comparator Agent |
Placebo four pills twice daily for seven days |
Placebo alongwith Standard treatment protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
COVID 19 confirmed individuals who are Asymptomatic and receiving standard treatment protocol
Age 18 years & above and of both sexes
Willing to sign written informed consent
|
|
| ExclusionCriteria |
| Details |
Pregnant women or lactating mothers
Immunocompromised persons on basis of medical history
Symptomatic COVID-19 individualsNot willing to give informed consent
|
|
|
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 |
| An individual remaining asymptomatic/ becoming symptomatic / virologically negative during the maximum duration of incubation period (21 days)/ till the patient is at CCC as per the standard treatment protocol (ICMR) |
At 5th day, 10th day, 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to become virologically negative through RT-PCR.
1.Time to appearance of clinical symptoms of COVID-19. |
At 5th day, 10th day, 15th day |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/06/2020 |
| Date of Study Completion (India) |
31/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Asymptomatic carriers of infectious diseases pose a significant challenge in mitigation efforts, since they display no symptoms but can still be contagious and pass on the disease to other people. For clinical management with symptomatic COVID19 cases there are array of drugs approved and further trials are ongoing. During this COVID19 outbreak, a group of experts (SAB, CCRH) discussed the sign and symptoms observed in COVID-19 patients of Wuhan, China from the recent publication of Lancet, “Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China”. Analysis of these symptoms was made to find out the genus epidemicus. Arsenicum album was emerged as Genus epidemicus.This has also been advised for prevention of ILI. In Hongkong, Homoeopaths have found Bryonia alba mostly indicated in Covid 19 patients . In another unpublished case series treated by Homoeopath in Iran and other countries prescribed Camphora 1M with encouraging outcomes. This openlabel randomized placebo controlled trial will be able to estimate the comparative effect of pre identified homoeopathic medicines in asymptomatic covid19 patients receiving standard treatment protocol. |