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CTRI Number  CTRI/2024/10/076062 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathy as an add-on to standard treatment of pulmonary tuberculosis 
Scientific Title of Study   Effectiveness of Individualized homeopathy as an add on to standard treatment of Pulmonary tuberculosis- a randomized parallel arm double blind, placebo-controlled study (HAPT Trial) 
Trial Acronym  HAPT – trial 
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-3 
Affiliation  Central Council for Research in Homoeopathy 
Address  Department of Epidemic Cell, Room 303, 61-65, Institutional Area, Opp. D Block, Janak Puri

South West
DELHI
110058
India 
Phone  9873404012  
Fax    
Email  ccrh.coll2022@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddharth Agarwal  
Designation  Associate Professor 
Affiliation  Autonomous State Medical College 
Address  Department of Medicine, OPD Block, Room 7, Dolatpura, Jalesar Rd, Firozabad

Firozabad
UTTAR PRADESH
283203
India 
Phone  9359934663  
Fax    
Email  sidaga21@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Saurabh 
Designation  Assistant Professor 
Affiliation  Autonomous State Medical College 
Address  Department of TB and Chest, Room no. 1, Dolatpura, Jalesar Rd, Firozabad

Firozabad
UTTAR PRADESH
283203
India 
Phone  9873314546  
Fax    
Email  drsyadav03@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy, 61-65, Institutional Area, Opposite D block, Janakpuri, New Delhi 110058 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy 
Address  61-65, Institutional Area, Opposite 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 Siddharth Agarwal   Autonomous State Medical College and Hospital  Department of Medicine, OPD Block, Room 7, Dolatpura, Jalesar Rd, Firozabad, Uttar Pradesh - 283203
Firozabad
UTTAR PRADESH 		 9359934663

sidaga21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A159||Respiratory tuberculosis unspecified,  
 
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  65.00 Year(s)
Gender  Both 
Details  Pulmonary tuberculosis patients with positive sputum culture.
Patients with controlled Diabetes mellites and hypertension with medication.
Patients who are willing to give written informed consent
 
 
ExclusionCriteria 
Details  Participation in another clinical trial.
Female patients in lactation period, pregnancy or planning to get pregnant during the trial.
Known patients with severe primary diseases such as cancer, cardiovascular system, digestive system, kidney, and hematopoietic system diseases.
Patients co-infected with HIV.
Patients with mental illness.
Subjects considered to be unable to complete the study, or not suitable for the study by researchers. 
 
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 
Clinical recovery of patient, termed as cure as per WHO criteria (Cure).  At 2nd, 3rd, 4th, 5th, 6th, 12th & 18th month 
 
Secondary Outcome  
Outcome  TimePoints 
Time to resolution of all pulmonary tuberculosis symptoms.
 		 At 2nd, 3rd, 4th, 5th, 6th, 12th & 18th month 
Change in severity of symptoms/resolution as per clinical syndromes associated with Pulmonary tuberculosis at every month.  every month 
Time to sputum conversion.  At 2nd, 3rd, 4th, 5th, 6th, 12th & 18th month 
Resolution of chest X-ray changes of lungs  At 2nd, 6th, & 12th month 
Change in Erythrocyte Sedimentation Rate   At 2nd, 6th, & 12th month. 
Change in C-reactive protein.  At 2nd, 6th, & 12th month 
Relapse in patients after 1 year of completion of treatment  at 12 month 
Adverse events throughout the study.  every month 
Compare Quality of Life (WHOQOL-Bref) in patients.  at 2nd, 6th, 12th & 18th month 
 
Target Sample Size   Total Sample Size="296"
Sample Size from India="296" 
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)   18/11/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Tuberculosis is one of the top ten leading causes of death worldwide owing to 1.5 million TB related deaths in 2018. About 44% of global TB cases in 2018 were reported from South-East Asia and India reported 27% cases, the highest in SEAR region.1 India has second highest burden of MDR-TB in the world with an estimated 99,000 new cases per year. TB continues to have a significant impact on healthcare in India. This study is undertaken utilizing homoeopathic medicine as an adjuvant to the standard treatment in TB Patients with ADRs were more susceptible to develop unfavorable results of anti-TB treatment which emphasizes on the importance of developing strategies to control ADRs both to improve the quality of life and to treat TB safely. The study focuses on Integrative homoeopathic treatment in improving the treatment outcome, decrease ADR and improve the quality of life leading to improved medication compliance. This shall be a randomized, parallel arm, double blind, placebo, controlled trial of 3 years duration. The primary objective of the study is to compare the effectiveness of individualized homoeopathic treatment as an add-on to the standard treatment in curing Pulmonary Tuberculosis.


 
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