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CTRI Number  CTRI/2020/06/026195 [Registered on: 28/06/2020] 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 an add-on in treatment of COVID-19  
Scientific Title of Study   Effectiveness of Individualized homoeopathy as an add-on to standard treatment of COVID-19 - A multicentric, randomized, parallel arm, single blind, placebo, controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
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

South West
DELHI
110058
India 
Phone  09873404012  
Fax    
Email  drdnayak@gmail.com  
 
Details of Contact Person
Scientific 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

South West
DELHI
110058
India 
Phone  09911127619  
Fax    
Email  anil23101961@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anupriya 
Designation  Research Officer/Scientist-I 
Affiliation  CCRH 
Address  61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058

South West
DELHI
110058
India 
Phone  09871139304  
Fax    
Email  anupriyaccrh@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy 
Address  61-65, Institutional Area, Opp. D Block, Janak Puri, New Delhi – 110058 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Juhi Gupta  Chirayu Hospital  Bhopal-Indore Highway Bhainsakhedi, Bairagarh, Bhopal, Madhya Pradesh 462030
Bhopal
MADHYA PRADESH 
9425609774

sanjanhvi@yahoo.co.in 
Dr Juhi Gupta  Hamidia Hospital  Sultania Road, Bhopal-462001
Bhopal
MADHYA PRADESH 
9425609774

sanjanhvi@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-CCRH  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 along with standard care  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 along with standard care  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  1. Hospitalized symptomatic patients with COVID-19 infection
2. Age between 18 years to 80 years
3. Both the sexes
4. Willing to give written informed consent
 
 
ExclusionCriteria 
Details  1. Severe heart, lung, kidney, brain, blood diseases or other important systemic diseases
2. Patients on ventilatory support
3. Immunocompromised patients
4. Subjects considered to be 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    
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical recovery of patient or requirement of life support (ventilator)/ death.  Ever 24 hr. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time to fever clearance
2. Change in severity of symptoms as per clinical syndromes associated with COVID - 19 infection.
3. Time to resolution of pneumonia
4. Time to recovery
5. Period of hospital stay
6. Requirement of conventional medication till clinical improvement
 
Ever 24 hr. 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   08/07/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet. 
Brief Summary   At present no specific treatment exist for Covid 19. Add on homoeopathy was effective in diseases like Dengue and AES with no reported adverse effects. This study will able to estimate the treatment effect of the add on homoeopathy in covid patients. In the absence any known anti-viral and vaccine any 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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