| CTRI Number |
CTRI/2025/10/096568 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the effect of individualized Homeopathic treatment for allergic asthma in children and adults (6–40 years) |
|
Scientific Title of Study
|
Assessing the efficacy of individualised Homoeopathic medicines in management of allergic asthma in age group 6-40 years |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tushar Mishra |
| Designation |
PhD scholar |
| Affiliation |
Dr.D.Y. Patil Homeopathic Medical College and research centre, Pune |
| Address |
Dr.D.Y. Patil Homeopathic Medical College and hospital ,sant tukaram nagar, pimpri,pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9923173604 |
| Fax |
|
| Email |
drtusharmishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tushar Mishra |
| Designation |
PhD scholar |
| Affiliation |
Dr.D.Y. Patil Homeopathic Medical College and research centre, Pune |
| Address |
Dr.D.Y. Patil Homeopathic Medical College and hospital, sant tukaram nagar, pimpri,pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9923173604 |
| Fax |
|
| Email |
drtusharmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDharmendra Sharma |
| Designation |
Principal |
| Affiliation |
Dr.D.Y.Patil Homeopathic Medical College and research centre, Pune |
| Address |
Dr.D.Y.Patil Homoeopathic Medical College and hospital ,sant tukaram nagar, pimpri
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9422330045 |
| Fax |
|
| Email |
Principal.homoeopathy@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil Homeopathic Medical College and research centre, Pune-411018,Maharashtra,India
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| DrDharmendra Sharma |
Dr.D.Y.Patil Homoeopathic Medical College and hospital |
Dr.D.Y.Patil Homoeopathic Medical College and hospital ,Homoeopathic department
Pune
Pune
MAHARASHTRA |
9422330045
Principal.homoeopathy@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.D.Y. Patil Homeopathic Medical College and research centre, Pune |
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 |
Individualised Homeopathic Medicine Dose: Depending on the laws of susceptibility, it will be Individualized dosage (from single dose to multiple doses). orally in pills Duration 6-12 weeks as per symptoms
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Physician-diagnosed asthma (documented in records) with symptoms consistent with bronchial asthma (wheeze, breathlessness, cough, variable airflow obstruction)
Ability to provide informed consent and compley with the study |
|
| ExclusionCriteria |
| Details |
Pregnancy or lactation
Severe systemic diseases (e.g., heart failure, severe kidney disease, severe liver disease)
Severe or unstable asthma — e.g.hospitalisation or emergency department visit |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in serum total Immunoglobulin E (IgE) levels |
Baseline and at 6 months (±2 weeks). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of asthma exacerbations during 6-month period (requiring oral corticosteroids, emergency visits, or hospitalization). |
Baseline and at 6 months (±2 weeks). |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
02/12/2025 |
| 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="3"
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
|
To assess the effect of individualised Homoeopathic medicines in diagnosed cases of allergic asthma in patients of age group of 6 years to 40 years will be taken for the interventional single arm study and change in serum total immunoglobulin E (IgE) levels from baseline to 6 months of treatment .This study aims to determine the potential role of individualised Homoeopathic medicines in cases of allergic asthma . |