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CTRI Number  CTRI/2025/03/082507 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 11/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathic medicines for the Treatment of Allergic Rhinitis  
Scientific Title of Study   Efficacy of Individualized Homoeopathic medicines in the Treatment of Allergic Rhinitis (Aeropalynological Studies of Purulia District): A Double-Blind, Randomized, Placebo-Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1319-3407  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Soumyabrata Dogra 
Designation  Homoeopathic Medical Officer ( HMO) 
Affiliation  SHD SADAR at Deben Mahata Govt Medical College and Hospital  
Address  Main road Near S.P.Office Purulia SHD SADAR at Deben Mahata Govt Medical College and Hospital

Puruliya
WEST BENGAL
723101
India 
Phone  9046974080  
Fax    
Email  dr.soumyasimilima@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Soumyabrata Dogra 
Designation  Homoeopathic Medical Officer ( HMO) 
Affiliation  SHD SADAR at Deben Mahata Govt Medical College and Hospital  
Address  Main road Near S.P.Office Purulia SHD SADAR at Deben Mahata Govt Medical College and Hospital

Puruliya
WEST BENGAL
723101
India 
Phone  9046974080  
Fax    
Email  dr.soumyasimilima@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Soumyabrata Dogra 
Designation  Homoeopathic Medical Officer ( HMO) 
Affiliation  SHD SADAR at Deben Mahata Govt Medical College and Hospital  
Address  Main road Near S.P.Office Purulia SHD SADAR at Deben Mahata Govt Medical College and Hospital

Puruliya
WEST BENGAL
723101
India 
Phone  9046974080  
Fax    
Email  dr.soumyasimilima@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF SCIENCE & TECHNOLOGY AND BIOTECHNOLOGY VIGYAN CHETANA BHAVAN GOVERNMENT OF WEST BENGAL DD-26/B, SECTOR I, SALT LAKE, KOLKATA - 700 064 
 
Primary Sponsor  
Name  DEPARTMENT OF SCIENCE & TECHNOLOGY AND BIOTECHNOLOGY VIGYAN CHETANA BHAVAN GOVERNMENT OF WEST BENGAL 
Address  DD-26/B, SECTOR I, SALT LAKE, KOLKATA - 700 064 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Deben Mahata Government Medical College and Hospital Purulia   Main road Near S.P.Office Purulia WB-723101 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Soumyabrata Dogra  Deben Mahata Government Medical College and Hospital  Main road Near S.P.Office Puruliya-723101 SHD Sadar Department of Homoeopathy Room no. 46
Puruliya
WEST BENGAL 
9046974080

dr.soumyasimilima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(EC/NEW/INST/2021/1862)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J301||Allergic rhinitis due to pollen,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical-looking placebo plus general management(Nasal irrigation, steam inhalation and proper diet)  This arm will be administered an identical looking placebo, indistinguishable from verum. Each dose consists of 4-6 cane sugar globules moistened with 90% v/v ethanol, to be taken orally in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Duration of therapy: 4 weeks.  
Intervention  Individualized homeopathic medicines in centesimal potencies plus general management(Nasal irrigation, steam inhalation and proper diet)  Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies. Each dose consists of 4-6 cane sugar globules moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally in empty stomach; dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Duration of therapy: 4 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient suffering from Allergic rhinitis (AR) for at least 1 year. Confirmative diagnosis of AR
by medical history, symptoms, skin prick tests (SPTs) or other biochemical parameters.
2. Subject must be symptomatic at screening and willing to maintain same environment
throughout the study.
3. Patients of both sexes; age 18-65 years.
4. Ability to read and write English or Bengali
5. Ability and willing to comply with study procedures.  
 
ExclusionCriteria 
Details  1. Having complications of nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug
rhinitis
2. Having complications of bacterial/viral infection of upper respiratory tract
3. Having significant systemic disease or any organ failure.
4. Subject suffering from any life threatening/Psychiatric/ illnesses or Immuno-compromised state
or other significant disease conditions.
5. Pregnant or lactating woman
6. Substance abuse or dependence
7. Patients planning to travel outside the region
8. Patients who participated in another study within 4 months before screening
9. Patients taking drugs for other illness
10. Patients who have taken any homoeopathic medicines in last 3 months.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Total Nasal Symptom Score (TNSS)  Baseline, 1st week, 2nd week, 3rd week and 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)  Baseline, 1st week, 2nd week, 3rd week and 4th week 
IgE estimation  Baseline and end point of study  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/04/2025 
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="2"
Months="0"
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  
Allergic rhinitis (AR) is a disorder in with episodes of nasal congestion watery nasal discharge and sneezing. It may be seasonal or perennial, and is due to an immediate hypersensitivity reaction in the nasal mucosa.  According to IUIS allergen nomenclature subcommittee over 150 pollen allergens from different weeds, grasses and trees are observed. More than 25% population in Indian is suffering from several types of allergies. 
Several trials have evaluated the effectiveness of homeopathy for AR. Results from these trials are mixed. Collectively, the results of these trials have been noted to be positive. A systematic review and meta-analysis reported efficacy of homoeopathic medicines in treating AR. In an single arm interventional study by Ghosh et al. reported improvement in chronic allergic rhinitis symptoms, IgE and Absolute eosinophil count after homoeopathic treatment.  No double-blind trial has been found in the Indian context. So, this trail will be conducted on 60 participants on a specified population (Aeropalynological Studies of Purulia District) to evaluate the effect of homoeopathic treatment beyond placebo at the Out-patient SHD Sadar at Deben Mahata Government Medical College and Hospital and Sidho-Kanho-Birsha University, Purulia. Assessment will be done by Total Nasal Symptom Score -TNSS (Primary outcome), Rhinoconjunctivitis Quality of Life Questionnaire -RQLQ and IgE estimation (Secondary outcome).  Comparative analysis will be carried out to detect group differences. The results will be published in scientific journal.
 
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