CTRI Number |
CTRI/2012/12/003193 [Registered on: 07/12/2012] Trial Registered Retrospectively |
Last Modified On: |
17/09/2014 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Homeopathy |
Study Design |
Single Arm Study |
Public Title of Study
|
Homeopathy in Treatment of Allergic Rhinitis |
Scientific Title of Study
|
An Open Label Pilot Study Testing the Role of Classical Homeopathy in Allergic Rhinitis |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
102/MBHMCH/CH/ADM/10 |
Protocol Number |
U1111-1136-4297 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Shubhamoy Ghosh |
Designation |
Lecturer of Department of Pathology and Microbiology |
Affiliation |
Mahesh Bhattacharyya Homeopathic Medical College & Hospital |
Address |
Mahesh Bhattacharyya Homeopathic Medical College and Hospital Government of West Bengal Drainage Canal Road Dumurjola Howrah Nabarun Apartment 75 Nagendra Nath Road Flat Number G2 Satgachi Kolkata Kolkata WEST BENGAL 711104 India |
Phone |
26774449 |
Fax |
|
Email |
shubhamoy67@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Shubhamoy Ghosh |
Designation |
Lecturer of Department of Pathology and Microbiology |
Affiliation |
Mahesh Bhattacharyya Homeopathic Medical College & Hospital |
Address |
Mahesh Bhattacharyya Homeopathic Medical College and Hospital Government of West Bengal Drainage Canal Road Dumurjola Howrah Nabarun Apartment 75 Nagendra Nath Road Flat Number G2 Satgachi Kolkata Kolkata WEST BENGAL 711104 India |
Phone |
26774449 |
Fax |
|
Email |
shubhamoy67@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Shubhamoy Ghosh |
Designation |
Lecturer of Department of Pathology and Microbiology |
Affiliation |
Mahesh Bhattacharyya Homeopathic Medical College & Hospital |
Address |
Mahesh Bhattacharyya Homeopathic Medical College and Hospital Government of West Bengal Drainage Canal Road Dumurjola Howrah Nabarun Apartment 75 Nagendra Nath Road Flat Number G2 Satgachi Kolkata Kolkata WEST BENGAL 711104 India |
Phone |
26774449 |
Fax |
|
Email |
shubhamoy67@gmail.com |
|
Source of Monetary or Material Support
|
Mahesh Bhattacharyya Homeopathic Medical College and Hospital |
|
Primary Sponsor
|
Name |
Mahesh Bhattacharyya Homeopathic Medical College and Hospital |
Address |
Drainage Canal Road Dumurjola Howrah 711104 West Bengal India |
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 |
Amitava Biswas |
Mahesh Bhattacharyya Homeopathic Medical College and Hospital Medicine OPD Room 12 every Monday |
Drainage Canal Road Doomurjola Howrah 711104 Haora WEST BENGAL |
26774449
principalmbhmch@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Chronic Allergic Rhinitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Individualized homeopathic medicines in appropriate dose |
Single individualized homeopathic remedy orally first in 30C potency, followed by higher and as appropriate - each dose was single drop of medicine in 15 ml distilled water - Repetition 2 to 6 hourly or even oftener, depending upon the intensity of symptoms - total duration of such intervention 1 year |
Comparator Agent |
Not applicable |
Only the role of homeopathic medicine in allergic rhinitis was tested and no comparator was used |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Inclusion criteria included diagnosed cases of chronic allergic rhinitis of minimum 1 year duration, age between 18 and 65 years, both sexes, atopic (reactive to allergens with positive skin prick test results) and/or eosinophilia, and written informed consent from the patient |
|
ExclusionCriteria |
Details |
Exclusion criteria consisted of nasal abnormalities causing obstruction, e.g. nasal polyp(s), deviated septum etc., previous homeopathic immunotherapy for allergic rhinitis, allergen avoidance in past 6 weeks, avoidance of usual environment for more than 1 week during trial, severe asthma cases as detected clinically, respiratory infection, presence of severe concomitant disease(s), pregnancy, breast feeding, or likelihood of pregnancy, oral or parenteral steroids and/or decongestant in past 6 months, and conventional desensitization in past 3 months |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Serum Immunoglobulin E level and Absolute Eosinophil Count |
1 year |
|
Secondary Outcome
|
Outcome |
TimePoints |
Quality of Life assessment score for patients with chronic allergic rhinitis |
1 year |
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/11/2010 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
To be published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The prevalence of
allergic rhinitis (AR) is increasing at an alarming rate throughout the
world. India has an estimated number of
15-20 million patients with allergic bronchial asthma and 30-80% of these
suffer from AR. So, AR is considered as a major chronic respiratory disease due
to its prevalence, impact on quality of life (QoL), work/school performance and
productivity, economic burden and links with asthma. This research aims at
testing the role of classical homeopathy in bringing changes in serum immunoglobulin
E (IgE) level and absolute eosinophil count (primary outcome measures) and QoL
issues related to AR (secondary outcome measures) by comparing the pre-trial
and post-trial data. An open label, single arm, experimental, prospective,
non-randomized, non-controlled, before and after comparison pilot study was
carried on thirty participants suffering from chronic AR. Institutional ethical
clearance was obtained; then thirty four consenting patients were enrolled
after screening by eligibility criteria and were allocated to classical homeopathic
treatment. Four cases were dropped out and thirty cases were regular. Outcome
measures were assessed and analyzed after one year. After one year of homeopathic treatment, lowering
of serum IgE level (1006.83±395.17 vs
336.5±126.96; P = 0.00003), absolute
eosinophil count of blood (600.33±103.61 vs
302.5±82.21; P = 0.00008) and QoL
scores of AR (113.67±17.85 vs
58.13±12.39; P = 0.00006) were
statistically significant. No adverse effects and/or complications were
observed. Data suggest
that classical homeopathic treatment may be a useful measure for the patients
suffering from chronic AR. However, multi-centric randomized controlled trials
with larger sample size and longer duration should be undertaken for
confirmation of the conclusion. |