| 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
|
|
|
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. |