| CTRI Number |
CTRI/2025/01/079493 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of homoeopathic medicine in the treatment of allergic bronchial asthma. |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicine as a discrete or as an adjuvant in the treatment of allergic bronchial asthma evaluated by serum Immunoglobulin E levels and spirometry measurements A double arm prospective nonrandomized 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 Deepshika Sharma |
| Designation |
postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE block Sector 3 Salt Lake Department of practice of medicine outpatient department room no. 24
Kolkata
WEST BENGAL
700106
India |
| Phone |
8240859967 |
| Fax |
|
| Email |
d3epshika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Gautam Pal |
| Designation |
Professor and HOD practice of medicine |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE block Sector 3 Salt Lake department of medicine outpatient department room no 24
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433902556 |
| Fax |
|
| Email |
drgautampal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepshika Sharma |
| Designation |
postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy GE block Sector 3 Salt Lake department of medicine outpatient department room no 24
Kolkata
WEST BENGAL
700106
India |
| Phone |
8240859967 |
| Fax |
|
| Email |
d3epshika@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR Deepshika Sharma self |
| Address |
National Institute of Homoeopathy GE block sector 3 Salt Lake 70016 |
| 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 Deepshika Sharma |
National Institute of Homoeopathy |
National Institute of Homoeopathy GE block Sector 3 Salt Lake department of medicine outpatient department room no 24
Kolkata
WEST BENGAL |
8240859967
d3epshika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, (2) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
individualized homoeopathic medicine along with conventional medicine. it will be a 6month study before after spirometry and serum ige will be taken |
patient already taking conventional medicine will be given add on homoeopathic treatment for 6months. |
| Intervention |
individualized homoeopathic treatment for 6 months will be given |
individualized homoeopathic treatment without conventional medicine for 6 months will be given |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are having signs and symptoms of allergic asthma.
Patients having increased IgE levels.
Patients with reduction in FEV1/ FVC ratio.
Patients of age 12 to 40 years of age, irrespective of their gender, race, religion and socio-
economic status
Willingness and ability to comply with scheduled visits, treatment plans and other study
procedures.
Patient must be capable of giving informed consent.
Patient will have option to decide whether to take homoeopathic medicine along with the conventional
treatment or to use homoeopathy as discrete mode of treatment. Both the type of patient will be
included in the study as two different arm of study |
|
| ExclusionCriteria |
| Details |
Patients who are diagnosed with an unstable mental or psychiatric illness or other
uncontrolled or life-threatening diseases including organ failure that affect the
quality of life
Patient suffering from status asthmaticus
Pregnant or lactating women
Patients on substance abuse. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome: Spirometry at base line and 6 months |
Primary outcome: Spirometry at base line and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IgE levels and ACT SCORE at baseline and 6months |
baseline and 6 months
|
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 |
|
Date of First Enrollment (India)
|
04/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/02/2025 |
| 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
|
RESEARCH QUESTION:
Is individualized homoeopathic medicine, as a discrete or as an adjuvant, effective in treatment of allergic
bronchial asthma evaluated based on serum IgE and spirometry measurements? HYPOTHESIS:
Null hypothesis (H0):
There is no significant change in IgE levels and spirometry measurements among patients suffering
from allergic bronchial asthma following the individualized homoeopathic medicine as a discrete or
as an adjuvant treatment.
Alternative hypothesis (HA):
There is significant change in serum IgE levels and spirometry measurements among patients
suffering from allergic bronchial asthma following the individualized homoeopathic treatment as a
discrete or as an adjuvant treatment. AIM:
To assess the effectiveness of individualized homoeopathic medicines as a discrete or as an adjuvant in
patients with allergic bronchial asthma. OBJECTIVES:
1. To assess the changes in serum IgE levels as well as spirometry in patients suffering from allergic
bronchial asthma following the individualized homoeopathic medicine as a discrete or as an adjuvant
treatment.
2. To assess the changes in asthma control test (ACT) score in patients suffering from allergic bronchial
asthma following the individualized homoeopathic medicine as an adjuvant treatment. The serum IgE levels, a blood parameter, spirometry levels, and the ACT score data will be collected
once at baseline and at 6 months duration following treatment which will be assessed in specially designed
Microsoft Office Excel spread sheet (master chart) for data extraction and statistical analysis. All cases will
be recorded in a standard case taking proforma. Data of the cases will be obtained from the patient
attendants, and physician’s own observations. Professional etiquette and ethics will be maintained at utmost
level. |