| CTRI Number |
CTRI/2025/11/097207 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Treatment of allergic rhinitis by homoeopathic medicine Galphimia glauca |
|
Scientific Title of Study
|
Efficacy of Galphimia glauca in the Treatment of Allergic Rhinitis: A
Double-Blind, Randomized, Placebo-Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1330-4587 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indrani Halder |
| Designation |
PhD Scholar |
| Affiliation |
Doctoral Studies and Research, Parul University |
| Address |
Jawaharlal Nehru Homoeopathic Medical college, Dept. of Repertory, Parul University
Limda, Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
7001295073 |
| Fax |
|
| Email |
indranihalder2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Poorav Desai |
| Designation |
Dean, Faculty of Homoeopathy and Principal of JNHMC, Parul University |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical college, Parul University |
| Address |
Jawaharlal Nehru Homoeopathic Medical college(JNHMC), Limda, Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9376225507 |
| Fax |
|
| Email |
poorav.desai@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indrani Halder |
| Designation |
PhD Scholar |
| Affiliation |
Doctoral Studies and Research, Parul University |
| Address |
Jawaharlal Nehru Homoeopathic Medical college, Dept. of Repertory, Parul University
Limda, Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
7001295073 |
| Fax |
|
| Email |
indranihalder2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College Hospital, Limda Lake road, Limda, Vadodara, Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Homoeopathic Medical College Hospital |
| Address |
Limda Lake road, Limda, Vadodara, Gujarat 391760 |
| Type of Sponsor |
Other [Private Medical College Hospital] |
|
|
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 Indrani Halder |
Jawaharlal Nehru Homoeopathic Medical College Hospital |
OPD, Room no. 110, Department of Medicine
Limda Lake road, Limda, Gujarat, 391760
Vadodara
GUJARAT |
7001295073
indranihalder2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Galphimia glauca as per indication in centesimal
potencies (CH) |
It is planned as administering Galphimia glauca as per indication in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the medicine
(preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition
depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the
globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. The medicine and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm.
Total duration of intervention: 2 months. |
| Comparator Agent |
Identical-looking placebos |
This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue in empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases.
All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm.
Total duration of comparator agent: 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient suffering from Allergic rhinitis (ICD 11 CA08.0Z) for at least 1 year.
2. Age 18 to 65 years.
3. Patients of either sex or transgender
4. Literate patients; ability to read and write in Gujarati, Hindi or English and willingness to give informed consent voluntarily and to comply with the study procedure
|
|
| ExclusionCriteria |
| Details |
1. Patient who are too sick for consultation
2. Having complications of bacterial/viral infection of upper respiratory tract
3. Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally or critically ill patients, mentally incompetent people.
4. Patients with risk of developing bronchial asthma
5. Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life
6. Pregnant and puerperal women, and lactating mothers
7. Substance abuse and/or dependence
8. Self-reported immune-compromised state
9. Not having any previous history of allergic attack of symptoms of AR
10. Patients who have taken any homoeopathic medicines in last 3 months and under any other medications for allergic rhinitis
11. Simultaneous participation in any other clinical trial.
|
|
|
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 |
| Mini- Rhino-Conjunctivitis Quality of Life Questionnaire (Mini-RQLQ) |
At baseline and every month up to 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF-12 |
At baseline and every month up to 2 months |
| Total serum IgE level and absolute eosinophil count (AEC) |
Baseline and after 2 months |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/11/2025 |
| 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 characterized by sneezing, nasal congestion, nasal itching and rhinorrhoea (nasal discharge) and is caused by immunoglobulin E (IgE)- mediated reactions to inhaled allergens. The disease currently affects between 10% and 30 % of the population. It was defined in 1929: The three cardinal symptoms in nasal reactions occurring in allergy are sneezing, nasal obstruction and mucous discharge. AR is a global health problem that causes major illness and disability worldwide. The ARIA guidelines for classification and treatment of allergic rhinitis have led to the definition of allergic nasal disease as intermittent or persistent and mild or moderate-to-severe. The diagnosis is based on the concordance between a typical history of allergic symptoms and diagnostic tests. 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. No double- blind trial has been found in the Indian context. This trial aims to evaluate the efficacy of Galphimia glauca in the treatment of allergic rhinitis. By meta-analysis in the year of 1997, significant superiority of Galphimia glauca (GG) over placebo is demonstrated. The research gap is despite the promising findings reported in the 1997 meta-analysis demonstrating the significant superiority of Galphimia glauca (GG) over placebo in alleviating symptoms of pollinosis (allergic rhinitis), several critical limitations remain that hinder the generalizability and robustness of the conclusions like lack of Intention-to-Treat (ITT) Analysis, unvalidated outcome measures, no replication and independent verification. So, by this double-blind, randomized (2:1), placebo controlled trial conducted at Jawaharlal Nehru Homoeopathic Medical College Hospital on 106 (Verum group- 71 and Control group 35) patients suffering from AR, it would be an attempt to overcome those limitations of previous studies and will act as future research evidence in homoeopathy for the treatment of AR as well as it will help for further systematic review and meta-analysis. Primary outcome measure will be Mini-RQLQ at baseline, every month up to 2 months of follow up. Secondary outcome measure will be (a) SF 12 at baseline, every month up to 2 months of follow up. (b) Serum IgE level and (c) Absolute Eosinophil Count (AEC) at baseline and end of 2 months of follow up. Group differences will be analyzed statistically. Results will be published in scientific journal. |