| CTRI Number |
CTRI/2024/12/078520 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of homoeopathy in management of bronchial asthma in children aged 6-18 years. |
|
Scientific Title of Study
|
Effect of individualized homoeopathic medicine as an adjunct to conventional medication in the management of bronchial asthma among 6-18 years of age group: a prospective pre & post study. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjan choudhury |
| Designation |
Pg scholar |
| Affiliation |
Bakson homoeopathic medical college and hospitalL COLLEGE AND HOSPITAL |
| Address |
Depertment of pediatrics ground floor room no g20 bakson homoeopathic medical college and hospital b36 knowledge park 1 greater noida uttar pradesh.
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7001640944 |
| Fax |
|
| Email |
ANJANC8@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet garg |
| Designation |
Guide & professor and hod |
| Affiliation |
Bakson homoeopathic medical college and hospital |
| Address |
Depertment of pediatrics ground floor room no g20 bakson homoeopathic medical college and hospital b36 knowledge park 1 greater noida uttar pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9411437669 |
| Fax |
|
| Email |
DRPUNEETGARG18@YAHOO.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini nair |
| Designation |
Pg incharge |
| Affiliation |
BBakson homoeopathic medical college and hospital |
| Address |
Depertment of homoeopathic materia medica second floor room no 1 bakson homoeopathic medical college and hospital b36 knowledge park 1 greater noida uttar pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9991078024 |
| Fax |
|
| Email |
PGINCHARGEBAKSON@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Bakson homoeopathic medical college and hospital
36B knowledge park 1 greater noida gautam buddha nagar uttar pradesh 201310
india |
|
Primary Sponsor
Modification(s)
|
| Name |
Bakson homoeopathic medical college and hospital |
| Address |
Principal office ground floor room no g 22 bkson homoeopthic medical college & hospital b36 knowledge park 1 greater noida uttar pradeh 201310
India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjan choudhury |
Bakson homoeopathic medical college and hospital |
Outpatient depertment (opd) room no 1 ground floor bakson homoeopathic medical college & hospital b 36 knowledge park 1 greater noida
Gautam Buddha Nagar
UTTAR PRADESH |
7001640944
ANJANC8@GMAIL.COM |
| Dr Anjan choudhury |
Dr. Dp rastogi central resarch institute of homoeopathy |
Out patient depertment (opd) room no 110 ground floor a 1/1 sector 24 noida 201301
Gautam Buddha Nagar
UTTAR PRADESH |
7001640944
ANJANC8@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bakson institutional ethics committee |
Approved |
| Central council for research in homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J45||Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic medicine |
Pill size 30.
Oral route of administration. Centesimal scale first dose after case taking.
Repetition according to follow-up |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Participant suffering with all types of asthma (allergic & non-allergic) and concurrent allergic condition.
Participant on bronchodilator & inhaler.
Spirometry values FEF(25-75%):
VALUES LESS THAN 70%
SIGNIFICANT RESPONSE TO BRONCHODIALOTOR (% IMPOVEMENT OVER BAELINE) : +25 |
|
| ExclusionCriteria |
| Details |
Participant with any other systemic disease or any immunocompromised condition.
Participant with severe psychiatric issue.
Participant who refused to give consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that after giving individualized homoeopathic medicine there will be reduction in the score of ASTHMA APGAR SCORE. |
Total 15 Months study
Enrollment Period – 6 Months
Follow Up – 6 Months
to be used at baseline, 2nd, 4th and 6th month.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SCALES: Asthma Quality of Life Questionnaire with Standardized Activities AQLQ(S). |
to be used at baseline, 6th month. |
| SPIROMETRY (FEF(25-75%)) |
to be used at baseline, 2nd, 4th and 6th month. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
01/01/2025 |
| 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="3"
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
|
This study is to assess the effectiveness of homoeopathic medicine in the management of bronchial asthma as an adjunct to conventional medication. Sample size 64 Single arm study: 15 months. scale used for screening : asthma apgar score. Scale used for assessment : asthma apgar score, Asthma Quality of Life Questionnaire with Standardized Activities AQLQ(S). , SPIROMETRY (FEF(25-75%) It is expected that to see positive changes in the asthma apgar score, Asthma Quality of Life Questionnaire with Standardized Activities AQLQ(S). , SPIROMETRY (FEF(25-75%)
|