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CTRI Number  CTRI/2024/06/069488 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 21/06/2024
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 in Prevention of Tuberculosis 
Scientific Title of Study   Effectiveness of Tuberculinum 200C in preventing latent and active tuberculosis in household contacts of index case - a prospective, household-cluster randomized, double blind, placebo controlled trial 
Trial Acronym  NIL 
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-III 
Affiliation  Central Council for Research in Homoeopathy 
Address  Room No. 303, 61-65, Institutional Area, Opp. D-Block, Janakpuri

South West
DELHI
110058
India 
Phone  01128525388  
Fax    
Email  drdnayak@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Debadatta Nayak 
Designation  Research Officer/ Scientist-III 
Affiliation  Central Council for Research in Homoeopathy 
Address  Room No. 303, 61-65, Institutional Area, Opp. D-Block, Janakpuri

South West
DELHI
110058
India 
Phone  01128525388  
Fax    
Email  drdnayak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amulya Ratna Sahoo 
Designation  Research Officer/ Scientist-III 
Affiliation  Regional Research Institute of Homoeopathy, Guwahati 
Address  Room No. 102, CARI Old Building (Ayurvedic Campus), Borsajai, P.O. Beltola, Kamrup Metro District, Guwahati

Kamrup
ASSAM
781028
India 
Phone  8763721546  
Fax    
Email  drarsahoo@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy, New Delhi, Ministry of AYUSH, Government of India 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy 
Address  61-65, Institutional area, opp. D-Block Janakpuri, New Delhi-110058 
Type of Sponsor  Government funding agency 
 
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 
Dr Amulya Ratna Sahoo  Regional Research Institute of Homoeopathy  Room No. 102, CARI Old Building (Ayurvedic Campus), Borsajai, P.O. Beltola, Kamrup Metro District, Guwahati
Kamrup
ASSAM 		 8763721546

drarsahoo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Regional Research Institute for Homoeopathy - Guwahati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Tuberculosis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Ethyl alcohol impregnated sugar globules to be given once a month for 3 months. 
Intervention  Tuberculinum 200C  Dosage for Adults – 4 globules of Tuberculinum 200C, to be given once a month for 3 months. Dosage for children - 2 globules of Tuberculinum 200C, to be given once a month for 3 months.  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  - Household contacts (HHC) of pulmonary TB (PTB) patients who are not infected with TB.
- One adult of household preferably parents voluntarily giving written informed consent to participate in the study. 
 
ExclusionCriteria 
Details  - Pregnant women or lactating mothers
- Immunocompromised individuals on basis of medical history
- Aged below 1 year
- Not willing to give written informed consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of latent or active tuberculosis infection among household contacts  Weekly 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse effect due to Tuberculinum 200C  Weekly 
Time to appearance of clinical symptoms of Tuberculosis   At the time of analysis 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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 3 
Date of First Enrollment (India)   01/08/2024 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
This is a prospective, household-cluster randomized, double blind placebo controlled trial to assess the effectiveness of Tuberculinum 200C in preventing the incidence of latent and active Tuberculosis among household contacts of the index case. In the study, approximately 1,000 apparently healthy participants, who are household contacts of Tuberculosis patients residing in Guwahati, Assam shall be enrolled in 02 groups. Group 1 (medicine group) shall be administered Tuberculinum 200C, one dose a month for 03 months; whereas, Group 2 (control group) shall be given placebo, one dose a month for 03 months. The participants shall be followed up for a period of 12 months (including 03 months of intervention).  The primary outcome measure will be the incidence of latent or active tuberculosis infection among household contacts. The secondary outcome measure will be adverse effects due to Tuberculinum 200C and time to appearance of clinical symptoms of Tuberculosis in household contacts (HHC) of pulmonary TB (PTB) patients.
 
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