| CTRI Number |
CTRI/2025/03/082228 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Treatment for Chronic Bronchitis |
|
Scientific Title of Study
|
Effect of Individualized Homoeopathic Medicines
in the Management of Chronic Bronchitis : A prospective, single arm, pre
post, clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1319-6287 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Paulomi Biswas |
| Designation |
Post Graduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine 265 266 Acharya Prafulla Chandra Road Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
8910961050 |
| Fax |
|
| Email |
chaiti.97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupali Bhaduri |
| Designation |
Reader Practice of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine 265 266 Acharya Prafulla Chandra Road Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9571806989 |
| Fax |
|
| Email |
drrupalibhaduri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupali Bhaduri |
| Designation |
Reader Practice of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine 265 266 Acharya Prafulla Chandra Road Kolkata
WEST BENGAL
700009
India |
| Phone |
9571806989 |
| Fax |
|
| Email |
drrupalibhaduri@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College and Hospital 265 266 Acharya Prafulla Chandra Road Kolkata West Bengal India Pin - 700009 |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265 266 Acharya Prafulla Chandra Road Kolkata 700009 |
| Type of Sponsor |
Government 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 |
| Paulomi Biswas |
The Calcutta Homoeopathic Medical College and Hospital |
Department of Practice of Medicine, OPD No. 17 and 21, 265 266 Acharya Prafulla Chandra Road Kolkata 700009
Kolkata
WEST BENGAL |
8910961050
chaiti.97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J410||Simple chronic bronchitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine in Q potency |
Intervention is planned as giving indicated Homoeopathic medicine in Q potency. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. 7 doses of medicine will be dispensed in 100ml of distilled water. 1 tablespoonful of medicine is to be mixed in half a cup of water after 10 uniformly forceful downward strokes
(from ear lobule to umbilicus which ends in a jerk), from which 1 teaspoonful is to be taken orally and the rest is to be discarded from the cup. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinical history of chronic cough with sputum expectoration for at least 3 months per year for two consecutive years
2. FEV1/FVC less than 0.7 and FEV1 greater than 80% predicted
3. Age between 18 and 65 years and of either gender
4. Individuals who can read and or write English or Bengali
5. Individuals willing to participate in trial and give written consent for the same. |
|
| ExclusionCriteria |
| Details |
1. Individuals who are currently on any other homoeopathic treatment or undergoing any kind of treatment for chronic bronchitis from any system of medicine
2. Individuals with life threatening diseases
3. Lung cancer known or suspected
4. Individuals requiring Oxygen therapy or hospitalisation
5. Pregnant or lactating mothers
6. Individuals having any substance abuse or severe psychiatric illness
7. Individuals who have not taken any other homoeopathic medicine for at least 6 weeks
8. Self-reported immunocompromised states |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in the FEV1/FVC through Spirometry in chronic bronchitis patients treated with Individualized Homoeopathic Medicine |
At the baseline and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the standard of treatment in chronic bronchitis patients with individualized homoeopathic medicine by using St. George’s Respiratory Questionnaire |
At the baseline and after 3 months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
18/03/2025 |
| 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="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
|
Chronic bronchitis (ICD-11 Code J41.0) is a chronic miasmatic disease which has been
classically defined as chronic cough with sputum expectoration for at least 3 months per year
for two consecutive years provided there are no other underlying cause that can explain these
symptoms (an important caveat that is often ignored). The hallmark symptom of CB is chronic cough which is often associated with sputum
production. According to the classic definition, this cough occurs for at least two years in a
row, lasts for three months each year, and is present on the majority of days in a month. In the appropriate clinical context CB can be diagnosed by the presence of non-reversible airflow obstruction (FEV1/FVC
< 0.7 post bronchodilation). Following preliminary screening for Chronic Bronchitis symptoms and
detailed screening using specified selection criteria, eligible patients will be recruited in the
trial. Following that, outcome data will be obtained. Each case will be studied properly through analysis and evaluation of each and every symptom
then accordingly qualitative picture will be constructed on the basis of totality of symptom to
prescribe simillimum.
Every patient will be assessed periodically to follow-up the reaction of the remedy through
SGRQ at the baseline and after 3 months. Spirometry will be done at the baseline and at the
end of 3 months. The usual follow up will be done at an interval of 4 weeks and will be recorded
in follow-up sheets. |