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CTRI Number  CTRI/2020/05/024969 [Registered on: 01/05/2020] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homoeopathy as adjuvant in management of Covid-19 infection 
Scientific Title of Study   Effect of adjuvant homoeopathy with standard treatment protocol in management of covid-19: a randomised, open label, placebo controlled, parallel group study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Pradeep Kumar Gupta 
Designation  Principal 
Affiliation  Naiminath Homoeopathic Medical College, Hospital and Research Centre 
Address  N.H.19, Firozabad Road, Nawalpur, Etmadpur, Agra, Uttar Pradesh

Agra
UTTAR PRADESH
283202
India 
Phone  9765270885  
Fax    
Email  nhmcagra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Debadatta Nayak 
Designation  Research Officer/Scientist-II 
Affiliation  CCRH 
Address  61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
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 Anil Khurana 
Designation  Director General Incharge 
Affiliation  CCRH 
Address  61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
South West
DELHI
110058
India 
Phone  09911127619  
Fax    
Email  anilnaman@rediffmail.com  
 
Source of Monetary or Material Support  
Naiminath Homoeopathic Medical College, Hospital and Research Centre  
 
Primary Sponsor  
Name  Naiminath Homoeopathic Medical College Hospital and Research Centre 
Address  N.H.19, Firozabad Road, Nawalpur, 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  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Dr Pradeep Kumar Gupta  F.H. Medical College and Hospital  Near Etmadpur, Railway over bridge, N.H -2 , Agra, Uttar Pradesh - 283201
Agra
UTTAR PRADESH 
9765270885

nhmcagra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-F H Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicine  Homoeopathic medicines will be given to this group patients as an add-on to standard treatmet. Following Individualization medicines will be selected keeping in view pathological aspect of disease. Dose and potency will be according to the frequency, intensity and duration of signs and symptoms. Repetitions will vary from cae to case basis cosidering disease state and vitality of patient. Range of potency from 30, 200, 1M etc will be used.  
Comparator Agent  Placebo  Placebo group patients will receive identical placebo (globules moistened with dispensing alcohol) as an add on to standard protocol treatment. Dose repetition will be a in similar pattern to medicine group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  o Symptomatic RT-PCR confirmed cases of
Covid-19 infection.
o Both sexes
o Age between 18 years to 80 years and
o Willing to give signed written informed
consent
 
 
ExclusionCriteria 
Details  1. Patients requiring ventilatory support
2. Patients with compromised immunity
3. Severe heart, lung, kidney, brain, blood
diseases or other important systemic
diseases
4. Subjects unable to complete the study, or
not suitable for the study by
researchers.
5. Women during pregnancy
6. Lactating mothers
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clinical outcome in terms of recovery of patient or requirement of life support (ventilator)/ death.  Ever 24 hr. 
 
Secondary Outcome  
Outcome  TimePoints 
i. Time to progression to critical stage
ii. Time to fever clearance
iii. Time to resolution of pneumonia
iv. Change in severity of symptoms as per clinical syndromes associated with COVID - 19 infection.
v. Time to recovery in terms of 2 negative test for Covid-19
vi. Period of hospital stay
vii. Requirement of conventional medication till clinical improvement
 
Ever 24 hr. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/05/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/05/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Brief Summary  

The results of the study will be able to predict the role of add on homoeopathic treatment for management of Covid-19 infected. In the absence any known anti-viral and vaccine the positive results of this study will decrease the morality and morbidity due to this pandemic. Further the cost-effectiveness of homoeopathy will enable developing countries in controlling such deadly disease effectively.

 
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