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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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