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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 Trial 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

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