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CTRI Number  CTRI/2024/09/073187 [Registered on: 02/09/2024] Trial Registered Prospectively
Last Modified On: 31/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of tuberculinum in comparison with individualised homoeopathic medicine in decreasing episodes of recurrent respiratory tract infections in children  
Scientific Title of Study   Efficacy of Tuberculinum in comparison with Individualised Homoeopathic medicine in reducing episodes of recurrent respiratory tract infections in children: A comparative, single blind, clinical 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 Snehal Bhagavan Patil 
Designation  PhD Scholar 
Affiliation  YMT Homoeopathic medical college and PG Institute 
Address  Department of medicine, YMT Homoeopathic medical college, Sector 4 Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  07774084330  
Fax    
Email  dr.snehalpatil91@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vasika Seliya 
Designation  PhD guide 
Affiliation  YMT Homoeopathic medical college and PG Institute 
Address  Department of medicine YMT homoeopathic medical college Sector 4 kharghar navi mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  09821351671  
Fax    
Email  drvasika@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Snehal Bhagavan Patil 
Designation  PhD Scholar 
Affiliation  YMT Homoeopathic medical college and PG Institute 
Address  Department of medicine, YMT Homoeopathic Medical College, Sector 4 Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  7774084330  
Fax    
Email  dr.snehalpatil91@gmail.com  
 
Source of Monetary or Material Support  
YMT Homoeopathic medical college and PG Institute, Sector 4 Kharghar, Navi Mumbai, Maharashtra, India-410210 
 
Primary Sponsor  
Name  DrSnehal Bhagavan Patil 
Address  YMT Homoeopathic medical college and PG Institute, Sector 4 Kharghar, Navi Mumbai, Maharashtra, India 410210 
Type of Sponsor  Other [self] 
 
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 Snehal Bhagavan Patil  YMT Homoeopathic Medical Hospital   Medicine OPD, YMT Homoeopathic medical college, Sector 4 Kharghar
Mumbai
MAHARASHTRA 
07774084330

dr.snehalpatil91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee YMT Homoeopathic Medical College and PG Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J06||Acute upper respiratory infectionsof multiple and unspecified sites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  INDIVIDUALISED HOMOEOPATHIC MEDICINE  Start with one dose of Individualised Homoeopathic Medicine orally If required medicine will be repeated or placebo powder will be given total Duration 1 year 
Intervention  Tuberculinum  Start with one dose of Tuberculinum 1M orally If required medicine will be repeated or placebo powder will be given total duration 1 year 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children with recurrent respiratory tract infections
more or equal 8 episodes per year if aged less than 3 years
more or equal 6 episodes per year if aged more or equal 3 years  
 
ExclusionCriteria 
Details  Lower Respiratory Tract Infections will be excluded
K/C/O history of Tuberculosis
Children with congenital anomaly affecting upper respiratory tract.
Children with Immunocomprised diseases and other co-morbidities.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
reduction in the number of episodes of
respiratory tract infection.  
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
effect of tuberculinum in reducing recurrence of respiratory tract infections  1 year 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 
Date of First Enrollment (India)   11/09/2024 
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="0"
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  

TITLE OF TOPIC – EFFICACY OF TUBERCULINUM IN COMPARISON WITH INDIVIDUALISED HOMOEOPATHIC MEDICINE IN REDUCING EPISODES OF RECURRENT RESPIRATORY TRACT INFECTIONS IN CHILDREN: A COMPARATIVE, SINGLE BLIND, CLINICAL TRIAL.

PURPOSE OF TRIAL

As there is increased prevalence of Recurrent respiratory tract infections, in conventional treatment there is only focus on symptomatic relief. There is no specific treatment for preventing recurrence of disease. Nevertheless, misuse and overuse of antibiotics results in unnecessary drug-related adverse events, contributes to antibiotic resistance and increased clinical failure, and incurs further medical costs.(3)

            Role of individualized Homoeopathic medicines in treatment of recurrent respiratory tract infections is known and also literatures are available on efficacy of tuberculinum in treating the recurrency of RRIs (20) though not many researches are done.        

INTRODUCTION

           Recurrent respiratory infections (RRIs) are a common occurrence in young children. The most widely accepted definition is the occurrence of eight or more documented airway infections per year in pre-school-aged children (up to 3 years of age) or of 6 or more in children older than 3 years of age, in the absence of any underlying pathological condition.(1)

            The National Family Health Survey 5, conducted in 2019–2020, reported a 2.4% prevalence of acute respiratory infections (ARIs) in the preceding 2 weeks in the urban areas and a 3.8% in the rural areas in Maharashtra state. In the Indian slum areas, ARIs constitutes more than two-thirds of all childhood illnesses. Globally, in 2010, nearly 265,000 in-hospital deaths of young children were attributed to ARIs, 99% of which were reported in developing countries. In the urban slum areas, ARIs constitutes over two-thirds of all childhood illnesses.(2)

              Recurrent respiratory infections lead to significant morbidity and mortality among paediatric patients. RRIs in children can lead to the number of consequences such as frequent visits to paediatric clinics, school absenteeism, overuse of antibiotics and bacterial resistance, decreased quality of life, absenteeism of parents at work and economic burden on the family.(3)

               Symptoms normally include at least one of the following: runny nose, nasal congestion, sore throat, cough, earache, and/or shortness of breath lasting at least two to three days or more.(3)

               Another important consequence of paediatric RRIs is the rampant and irrational use of antibiotics. Most of the respiratory infections are viral in origin and frequent irrational use of broad-spectrum antibiotics can lead to antibacterial resistance. Despite the use of antibiotics and vaccines, the incidence of RRIs is still high in children due to the deficiency of the immune system.(1)

             Homoeopathy treats patients through the holistic approach which considers treating patient as a whole and not just the disease. Homoeopathic medicines are prescribed on the basis of individualization.  Where each patient is given a different remedy depending on his or her constitution that is considering his mental and physical make up, past history and family history.  So on this basis we have the individualised homoeopathic medicines for RRIs. but we also have Tuberculinum as one of our main homeopathic medicine for children, especially those who suffer from recurrent infection, but not much proving of Tuberculinum is done yet in recurrent respiratory tract infections.

             So Keeping burden of disease in mind and ability of Tuberculinum to treat tendency of recurrency, hence the study is designed to compare the efficacy of Tuberculinum with Individualised homoeopathic medicines in reducing episodes of RRIs.

AIM: to study the efficacy of tuberculinum in comparison with individualised homoeopathic medicine in reducing episodes of recurrent respiratory tract infections in children up to 2 years.

OBJECTIVES:

        To assess the reduction in the frequency, duration and intensity of recurrent respiratory tract infections in children up to 2 years.

        To study the effect of treatment on clinical presentation of recurrent respiratory tract infection in children up to 2 years.

        To study the symptoms of tuberculinum.


 
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