| CTRI Number |
CTRI/2025/02/080899 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment in Acute Bronchitis |
|
Scientific Title of Study
|
Effectiveness of individualized Homoeopathic medicine in the management of Acute Bronchitis |
| 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 Brijesh Kumar Yadav |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Organon of Medicine
State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7390968816 |
| Fax |
|
| Email |
yadavbrijesh695@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tripti Gupta |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Obstetrics and Gynaecology
State National Homoeopathic Medical College and Hospital Viraj Khand Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
6306332838 |
| Fax |
|
| Email |
dr.triptigupta2013@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tripti Gupta |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Obstetrics and Gynaecology
State National Homoeopathic Medical College and Hospital Viraj Khand Gomti Nagar Lucknow
UTTAR PRADESH
226010
India |
| Phone |
6306332838 |
| Fax |
|
| Email |
dr.triptigupta2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow Uttar Pradesh India 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Brijesh Kumar Yadav |
| Address |
State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow Uttar Pradesh India 226010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Brijesh Kumar Yadav |
State National Homoeopathic Medical College and Hospital |
OPD NO 1
Department of Organon of Medicine
State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH |
7390968816
yadavbrijesh695@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee state national homoeopathic medical college lucknow |
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 |
| Intervention |
Individualized Homoeopathic Medicine |
Intervention planned as after obtaining consent and proper case taking of all enrolled patients will be done in a standardized case taking proforma which is being used in State National Homoeopathic Medical College and Hospital Lucknow. Individualized Homoeopathic Medicine will be prescribed to all patients after analysis and evaluation of Symptoms and proper repertorization using synthesis repertory. Indicated Homoeopathic medicine will be administered to the case or condition in required potencies and does depending upon the individual case.
Medicine will be taken orally.
Each case will be followed up at regular interval as per requirement Preferably at a period of 7 days.
General non medicinal management which includes appropriate proper diet and regimen will be advised as and when required. Progress of patient will be assessed through Hulls airway reflux questionnaire |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 6 to 65 years diagnosed with acute bronchitis.
2. Patients presenting symptoms such as cough fever chest pain and for less than or equal to 2 weeks.
3. Patients who can provide informed consent or assent and comply with the study protocol. |
|
| ExclusionCriteria |
| Details |
1. Patients with any severe systemic disorder
2. Pregnant female and lactating mothers and women who are planning for pregnancy
3. Patients who are not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will give the individualized Homoeopathic Medicine which will be useful in the management of acute bronchitis. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. At the end of study it is expected that Homoeopathic medicine selected on the basis of individualization will prove effective in the management of acute bronchitis
2. The study will determine whether the quality of life of the patients suffering from acute bronchitis can be improved by using Individualized Homoeopathic Medicine. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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
|
Acute bronchitis affects 5% of adults and 6% of children only with an estimated Global incidence of 20-30 cases per 1000 population. High prevalence in pollution affected areas makes that a significant Public Health concern. Homoeopathy s individualized approach addresses physical and emotional aspect making it a promising integrative therapy for acute bronchitis. A sample of 30 patients will be collected from the OPD and IPD of State National Homeopathic Medical College and Hospital Lucknow, aged 6 to 65 years screened and diagnosed on the basis of clinical symptoms of acute bronchitis and clinical examination. Individualised Homoeopathic medicine on the basis of laws after detailed case taking and repertorization as per the requirement of the individual case, will be followed up in 7 days and results will be analysed on the basis of clinical symptoms and from Hull airway reflux questionnaire. At the end of the study it is expected that homeopathic medicine selected on the basis of individualisation will prove effective in the management of ACUTE BRONCHITIS and the study will determine whether the quality of life of the patients suffering from acute bronchitis can be improved by improved by using individualized Homoeopathic medicine. |