| 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
|
|
|
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
|
|
|
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. |