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CTRI Number  CTRI/2020/05/025049 [Registered on: 06/05/2020] Trial Registered Prospectively
Last Modified On: 05/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Cluster Randomized Trial 
Public Title of Study   A CLINICAL TRIAL TO STUDY THE EFFICACY OF HOMOEOPATHIC MEDICINE IN PREVENTION AND CURE OF CORONA VIRUS DISEASE 19 
Scientific Title of Study   PROVING THE EFFICACY OF HOMOEOPATHIC TREATMENT IN PREVENTION AND CURE OF COVID 19 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR DHIRENDRA TIWARI 
Designation  DIRECTOR 
Affiliation  SAI NIDAN HOMOEOPATHY CLINIC 
Address  SAI NIDAN HOMOEOPATHY CLINIC NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH,

Surguja
CHHATTISGARH
497001
India 
Phone  8770568212  
Fax    
Email  drdhiren16@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  DR DHIRENDRA TIWARI 
Designation  DIRECTOR 
Affiliation  SAI NIDAN HOMOEOPATHY CLINIC 
Address  SAI NIDAN HOMOEOPATHY CLINIC NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH,


CHHATTISGARH
497001
India 
Phone  8770568212  
Fax    
Email  drdhiren16@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  DR DHIRENDRA TIWARI 
Designation  DIRECTOR 
Affiliation  SAI NIDAN HOMOEOPATHY CLINIC 
Address  SAI NIDAN HOMOEOPATHY CLINIC NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH,


CHHATTISGARH
497001
India 
Phone  8770568212  
Fax    
Email  drdhiren16@yahoo.co.in  
 
Source of Monetary or Material Support  
LATE VEDVATI DUBEY SIKSHAN SAMITI, AMBIKAPUR, CHHATTISGARH 497001  
SAI NIDAN HOMOEOPATHY CLINIC NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH, 497001  
 
Primary Sponsor  
Name  SAI NIDAN HOMOEOPATHY CLINIC 
Address  NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH, 497001  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
DR ASHISH DUBEY  LATE VEDVATI DUBEY SIKSHAN SAMITI, AMBIKAPUR, CHHATTISGARH 497001  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR DHIRENDRA TIWARI  SAI NIDAN HOMOEOPATHY CLINIC  NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH, 497001
Surguja
CHHATTISGARH 
9926190306

drdhiren16@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CG H R I INSTITUTIONAL ETHICS COMMITTEE  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  ARSENIC ALBUM 30  HOMOEOPATHIC MEDICINE ARSENIC ALBUM IN POTNTISED FORM OF 30 CENTICIMAL POTENCY OD DAILY FOR 3 DAYS 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  MALES OR FEMALES WITH A DIAGNOSIS OF COVID 19 AND MALES OR FEMALES QUARANTINE PERSON FOR COVID 19 
 
ExclusionCriteria 
Details  NIL 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary endpoint of this trial will be measured in terms of clinically recovered cases (covid 19 negative)or death  1 MONTH 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the quality of life w.r.t. activity, appetite , sleep and general condition of patient. fever clearance , changes in severity of symptoms, resolution of pneumonia  every 7 days 
Suspected cases in quarantine confirmed as negative  14 days 
 
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)   08/05/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary   THIS STUDY IS A CLUSTER RANDOMIZED TRIAL OF HOMOEOPATHIC MEDICINE ARSENIC ALBUM 30 OD DAILY 3 DAYS IN COVID 19 POSITIVE PERSONS AND SUSPECTED QUARANTINE PERSONS THAT WILL BE CONDUCTED IN 4 CENTRES IN INDIA. THE PRIMARY OUTCOME MEASURES WILL BE EFFICACY IN CURING AND PREVENTION OF COVID19. THE SECONDARY OUTCOME WILL BE PREVENTION OF COVID19. 
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