| CTRI Number |
CTRI/2025/09/094312 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathy in Bronchial Asthma |
|
Scientific Title of Study
|
Effectiveness of Individualised Homoeopathic Medicines Selected Using Allens Encyclopedia of Pure Materia Medica in the Management of Bronchial Asthma: A Prospective, Open-Label, Single-Arm 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 Vivek Kumar |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, Nehru Homoeopathic Medical College and Hospital
B-Block, Defence colony, New Delhi
South
DELHI
110024
India |
| Phone |
9319907220 |
| Fax |
|
| Email |
vkmr029@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr George Mathew |
| Designation |
Professor, Head Of Department |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, Nehru Homoeopathic Medical College and Hospital
B-Block, Defence colony, New Delhi
South
DELHI
110024
India |
| Phone |
7982783132 |
| Fax |
|
| Email |
drgeorgem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr George Mathew |
| Designation |
Professor, Head Of Department |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, Nehru Homoeopathic Medical College and Hospital
B-Block, Defence colony, New Delhi
South
DELHI
110024
India |
| Phone |
7982783132 |
| Fax |
|
| Email |
drgeorgem@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nehru Homoeopathic Medical College and Hospital, B-Block, Defence colony, New Delhi-110024 |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic Medical College and Hospital |
| Address |
B-Block, Defence colony, New Delhi-110024 |
| 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 |
| Dr VIVEK KUMAR |
Nehru Homoeopathic Medical College and Hospital |
OPD-5, Respiratory Project, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence colony, New Delhi-110024
South
DELHI |
9319907220
VKMR029@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics committee -NHMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
individualised homoeopathic medicine |
Participants will receive individualised homoeopathic medicines, selected based on
homoeopathic principles, using Allen’s Encyclopedia of Pure Materia Medica as the
primary reference for remedy confirmation.
Study Duration: 12 months
Enrolment period: 6 months
Follow ups, data analysis and report writing: 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with clinical signs & symptoms consistent with bronchial asthma,
after confirming the diagnosis with Lung Function Tests (spirometry).
2. Patients with a confirmed diagnosis of bronchial asthma by a qualified medical
practitioner (based on clinical history and/or diagnostic tests).
3. Patients aged between 17 to 70 years irrespective of their gender.
4. Patients on conventional treatment for bronchial asthma.
5. Patients who are willing to participate and provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Participants meeting any of the following criteria will be excluded from the study:
1. Patients diagnosed with severe persistent asthma with significant restriction of daily
activities.
2. Patients experiencing status asthmaticus.
3. Patients with serious complications or uncontrolled/life-threatening systemic illnesses
(e.g., cardiac failure, uncontrolled diabetes, renal or hepatic failure).
4. Patients diagnosed with any psychiatric illness that may interfere with compliance or
assessment.
5. Pregnant women and lactating mothers.
6. Individuals with a history of substance abuse or dependence.
7. Patients unwilling or unable to provide informed consent or participate in the study
procedures.
8. Individuals with a self-reported immunocompromised state (e.g., HIV, ongoing
immunosuppressive therapy). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
proportion of patients showing a clinically significant
improvement in ACT scores |
ACT will be estimated at baseline & at every 4 week interval. Final assessment will be done after 6 months of enrolment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in quality of life using AQLQ(S) & documentation of the spectrum of prescribed medicines |
AQLQ(S) scores will be estimated at baseline & at every 4 weeks. Final assessment will be done after 6 months of enrolment. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/10/2025 |
| 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
|
This prospective, open-label, single-arm clinical trial will be conducted at Nehru Homoeopathic Medical College and Hospital, New Delhi, to evaluate the effectiveness of individualised homoeopathic medicines in the management of bronchial asthma. A total of 40 patients aged 17–70 years with a confirmed diagnosis of bronchial asthma will be recruited based on predefined inclusion and exclusion criteria. Written informed consent will be obtained before enrolment. Patients will undergo detailed case taking, repertorization using Synthesis repertory (RADAR software), and final remedy confirmation from Allen’s Encyclopedia of Pure Materia Medica. Medicines will be dispensed free of cost from GMP-certified pharmacies in commonly used potencies (30C, 200C, 1M) in medicated globule form. The intervention will be provided alongside patients’ existing conventional treatment, and follow-up will be scheduled fortnightly. Data will be collected at baseline and monthly intervals using validated tools, including the Asthma Control Test (ACT), spirometry, and the standardized Asthma Quality of Life Questionnaire (AQLQ(S)). The primary outcome will be the proportion of patients showing a clinically significant improvement in ACT scores (more than or equal to 3 points). Secondary outcomes include improvement in quality of life and documentation of the spectrum of prescribed medicines. Statistical analysis will include descriptive statistics, paired t-test/Wilcoxon signed-rank test, McNemar’s test, and exact binomial test, with significance set at p<0.05. Both intention-to-treat and per-protocol analyses will be performed, and missing data will be managed using last observation carried forward. Ethical clearance has been obtained, pharmacovigilance will be ensured, and CTR-I registration will be completed prior to study initiation. Participation is voluntary, and confidentiality will be maintained. |