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CTRI Number  CTRI/2025/08/092638 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role of homoeopathic treatment in the management of acute bronchitis  
Scientific Title of Study   Role of exciting causes in the homoeopathic management of acute bronchitis: a clinical study 
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 KRITHIKA G 
Designation  JUNIOR RESIDENT 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  Room no 403 3rd floor College Building Department of Organon of Medicine Sarada Krishna Homoeopathic Medical College Kulasekharam Kanniyakumari district Tamilnadu India

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9400643144  
Fax    
Email  krithikagk02@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MANOJ NARAYAN V 
Designation  PROFESSOR 
Affiliation  Sarada Krishna Homoeopathic Medical College. 
Address  Room no 403 3rd floor College Building, Department of Organon of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari district, Tamilnadu,India

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9995114518  
Fax    
Email  manojnarayanv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MANOJ NARAYAN V 
Designation  PROFESSOR 
Affiliation  Sarada Krishna Homoeopathic Medical College. 
Address  Room no 403 3rd floor College Building, Department of Organon of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari district, Tamilnadu,India

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9995114518  
Fax    
Email  manojnarayanv@gmail.com  
 
Source of Monetary or Material Support  
INSTITUTION- Sarada krishna homoeopathic medical college,Kulasekharam, Kanniyakumari district, Tamilnadu,India 629161 
 
Primary Sponsor  
Name  Post graduate research funded by college 
Address  Sarada krishna homoeopathic medical college, Kulasekharam, Kanniyakumari district, Tamilnadu.629161 
Type of Sponsor  Private medical college 
 
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 KRITHIKA G  Sarada Krishna Homoeopathic Medical College  Department of Organon, Opd, Ipd,Rural Health Centres, Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari, TamilNadu, 629161.
Kanniyakumari
TAMIL NADU 
9400643144

krithikagk02@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Committee sarada krishna homoeopathic medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J209||Acute bronchitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Similimum based on exciting cause  Case taking, selection and administration of medicine will be based on Homoeopathic principles. Homoeopathic similar remedy is prescribed for the totality of symptom erected based on etiological factors and the existing symptoms. Intervention of the study is based on disappearance in symptoms in patients before and after homoeopathic management in the duration of 3 weeks. Pre-assessment and post-assessment will be done using the Bronchitis Severity Scale to evaluate the improvement of the patient every week 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of both sexes
Patient between the age group 6 yrs to 60 yrs
Patients having symptoms of Acute Bronchitis such as dyspnoea, productive cough, chest discomfort.
 
 
ExclusionCriteria 
Details  Pregnant and Lactating women.
Patients with any severe chronic illnesses
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in intensity and duration of Acute Bronchitis
symptoms as assessed by Modified Bronchitis Severity
Score (BSS) over 3 weeks.
Time taken to achieve relief from primary symptoms
(e.g., cough, expectoration, dyspnoea) after
administration of the indicated homoeopathic medicine based on exciting cause.  
3 weeks.
 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of the role of exciting causes (e.g., exposure to cold, dust, allergens, emotional stress) in remedy selection and individualized treatment.
Correlation between exciting cause-based remedy
selection and clinical outcomes, analyzed through patient case records and follow-up data.  
3 Weeks 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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/ Phase 4 
Date of First Enrollment (India)   25/08/2025 
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="1"
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  

Acute Bronchitis is a short-term inflammation of the large and mid-sized airways, typically lasting less than three weeks and not involving pneumonia. It commonly occurs in winter and is mainly caused by viruses such as influenza, RSV, rhinovirus, adenovirus, and coronavirus (including SARS-CoV-2). Bacterial causes like Mycoplasma pneumoniae, Chlamydia pneumoniae, and Bordetella pertussis are rare. Symptoms include dry or productive cough and respiratory rales. Risk factors include exposure to smoke, air pollution, dust, and pre-existing lung conditions like asthma and COPD. Acute cough is a common reason for doctor visits across all age groups, often overlapping with symptoms of colds, pneumonia, and asthma. In the U.S., about 5% of people are diagnosed with acute bronchitis annually, with higher rates in winter and in children under 5. In the U.K., incidence ranges from 36 per 1,000 in younger men to 225 per 1,000 in those over 85. In India, chronic bronchitis affects 3.49% of adults aged 35 and above, impacting an estimated 14.84 million people. Most existing studies on homeopathic treatment for acute bronchitis focus primarily on symptom-based prescriptions, with minimal attention given to the role of exciting causes. As there are only limited research papers considering the exciting causes in the treatment of Acute Bronchitis, there is a need for research that evaluates how exciting causes influence disease progression and treatment outcomes, providing a more individualized and causative approach to homeopathic management. By examining the symptoms and individualized Homoeopathic remedies, the study aims to contribute to improved patient care in the management of acute bronchitis. Improvement of the symptoms is assessed using Bronchitis Severity Scale.


 
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