| CTRI Number |
CTRI/2020/04/024926 [Registered on: 30/04/2020] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial to ascertain the effect of Homoeopathic Medicines in prevention of outbreak of symptoms in asymptomatic Corona virus and suspected Corona virus patients |
|
Scientific Title of Study
|
A Single Blind, Single Arm Clinical Trial to ascertain the effect of Homoeopathic Medicines in arresting the pathogenesis of disease in asymptomatic Corona virus and suspected Corona virus Patients |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| C-2020/05 dated: 27th April 2020 Version 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritu Gupta |
| Address |
N.H. 19, Firozabad Road, Nawalpur, Etmadpur, Agra, Uttar Pradesh - 283202
Agra
UTTAR PRADESH
283202
India |
| Phone |
8193896328 |
| Fax |
|
| Email |
ritudrgupta@gmail.com |
|
Details Contact Person
Scientific Query
|
| Name |
Dr Ritu Gupta |
| Address |
N.H. 19, Firozabad Road, Nawalpur, Etmadpur, Agra, Uttar Pradesh - 283202
UTTAR PRADESH
283202
India |
| Phone |
8193896328 |
| Fax |
|
| Email |
ritudrgupta@gmail.com |
|
Details Contact Person
Public Query
|
| Name |
Dr Ritu Gupta |
| Address |
N.H. 19, Firozabad Road, Nawalpur, Etmadpur, Agra, Uttar Pradesh - 283202
UTTAR PRADESH
283202
India |
| Phone |
8193896328 |
| Fax |
|
| Email |
ritudrgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Naiminath Homoeopathic Medical College, Hospital and Research Centre, Agra |
|
|
Primary Sponsor
|
| Name |
Naiminath Homoeopathic Medical College Hospital and Research Centre |
| Address |
N.H.19, Nawalpur, Firozabad Road, Etmadpur, Agra, Uttar Pradesh - 283202 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritu Gupta |
Naiminath Homoeopathic Medical College, Hospital and Research Centre |
N.H. 19, Firozabad Road, Nawalpur, Etmadpur, Agra, Uttar Pradesh - 283202
Agra
|
8193896328
ritudrgupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC - Naiminath Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Coronavirus as the cause of diseases classified elsewhere |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine: Arsenic Album, Bryonia Alba, Gelsemium, Antimonium Tartaricum, Crotalus Horridus |
100 ml water with 1 drop of indicated Homoeopathic Medicine in 30/ 200/ 1M potency every 2 hourly. Oral route of Administration. Duration of therapy will be 30 days.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
•Asymptomatic patients confirmed positive with COVID-19 tests criteria will be included.
•Suspected corona virus patients who are quarantined will also be included.
•Patients with age groups of 5-70 years.
•Patients who are willing to give informed consent for treatment.
|
|
| ExclusionCriteria |
| Details |
•Symptomatic patients confirmed positive with COVID-19 tests criteria will be included.
•More than 70 years of age and less than age of 5 years.
•Subjects considered not suitable for the study by the researchers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary endpoint of this trial will be measured in terms of clinically recovered case (Covid-19 negative) or appearance of symptoms where conventional treatment starts |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of life w.r.t. activity, appetite, sleep and general condition of the patient. |
4 days |
| Suspected cases in quarantine confirmed as negative |
14 days/ until discharge
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
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
|
Nil |
|
Brief Summary
|
The
primary aim of this study is to assess the effect of Homoeopathic treatment in
arresting the pathogenesis of disease in asymptomatic infected corona virus
patients as well as suspected patients who are placed in quarantine. We will
also evaluate the time of recovery of such patients after Homoeopathic
intervention. In cases where symptoms do appear after the intervention, time
taken to reach that stage will be evaluated in order to study the effect of
Homoeopathic intervention during this stage of the pathogenesis of the disease.
Suspected patients who are not confirmed Corona virus positive, waiting for the
test results but are placed in quarantine will also be given Homoeopathic
medicine under this trial and the test results will be evaluated thereafter to
study the effect of Homoeopathic treatment for such patients.
Effective Homoeopathic treatment for
this section of patients can be a game changer in this pandemic since it may
prove to be a vital treatment against corona virus infection when it is in
early stage of pathogenesis. |
