| CTRI Number |
CTRI/2025/05/087408 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effects of Galphimia Glauca and individualized homoeopathic medicines in allergic rhinitis(nose allergies) |
|
Scientific Title of Study
|
Effectiveness of Galphimia Glauca and Individualized Homoeopathic Medicines in Allergic Rhinitis: A Prospective Open Label Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jemshida P |
| Designation |
Post Graduate Student |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Materia Media
Government Homoeopathic Medical College
Karaparamba
Kozhikode
Kozhikode KERALA 673010 India |
| Phone |
9847924005 |
| Fax |
|
| Email |
jemshidahabeeb90@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arun Prasad K P |
| Designation |
Guide |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Materia Media
Government Homoeopathic Medical College
Karaparamba
Kozhikode
Kozhikode KERALA 673010 India |
| Phone |
9846040847 |
| Fax |
|
| Email |
appoo.ap@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Arun Prasad K P |
| Designation |
Guide |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Materia Media
Government Homoeopathic Medical College
Karaparamba
Kozhikode
KERALA 673010 India |
| Phone |
9846040847 |
| Fax |
|
| Email |
appoo.ap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College Karaparamba
Kozhikode
PIN : 673010
India |
|
|
Primary Sponsor
|
| Name |
Dr Jemshida P |
| Address |
Post Graduate Student
Department of Materia Medica
Government Homoeopathic Medical College
Karaparamba
Kozhikode
PIN : 673010
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Jemshida P |
Government Homoeopathic Medical College Kozhikode |
Research op
Ground floor
Old building
Government Homoeopathic Medical College
Karaparamba
Kozhikode
Kozhikode KERALA |
09847924005
jemshidahabeeb90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical Committee Government Homoeopathic Medical College Kozhikode |
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 |
Homoeopathic medicine Galphimia Glauca from 6C to 200 potency will be administered orally according to the principles of Homoeopathy for 12 weeks |
| Comparator Agent |
Individualized Homoeopathic medicines |
Individualized Homoeopathic medicines in various potencies according to totality of symptoms and principles of Homoeopathy will be administered orally for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Individuals meeting case definition of allergic rhinitis
Patients in the age group of 18-50
|
|
| ExclusionCriteria |
| Details |
Patients with symptoms of asthma
Individuals with serious life threatening illness like cardiac complaints and renal failure
Pregnant and lactating mother
Patients taking antihistamines or having received antihistamine therapy or corticosteroids in past two weeks |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effects of 12 weeks treatment with Galphimia Glauca and Individualized Homoeopathic Medicine on Total Nasal Symptom Score in patients of the age group of 18-50 years with allergic rhinitis |
To compare the effects of 12 weeks treatment with Galphimia Glauca and Individualized Homoeopathic Medicine on Total Nasal Symptom Score in patients of the age group of 18-50 years with allergic rhinitis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effects of 12 weeks treatment with Galphimia Glauca and Individualized Homoeopathic Medicine on serum IgE in patients of the age group of 18-50 years with allergic rhinitis.
To compare the effects of 12 weeks treatment with Galphimia Glauca and Individualized Homoeopathic Medicine on Total Ocular Symptom Score in patients of the age group of 18-50 years with allergic rhinitis.
|
0, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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 3 |
|
Date of First Enrollment (India)
|
05/06/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 an IgE mediated immune response towards an inhaled allergen producing symptoms like sneezing, nasal congestion, running nose and nasal pruritis with ocular symptoms like itchy watery eyes and redness of eyes. The most common allergens include hay and dust,mold spores, seasonal pollens and animal hairs.Today, allergic rhinitis poses a major health concern to over 60 million people in Europe and over 400 million people globally.This increased incidence and prevalence of allergic rhinitis will impair the individual’s quality of life, reduce the performance at work and affect the psychological wellbeing and cognitive function.The conventional system of medicines mainly uses antihistamines for allergic rhinitis. But the pharmacological studies show that the first generation antihistamines are less effective and also they have unwanted side effects on central nervous system causing sedation, performance deficit on memory, intelligence, vigilance and speed. Homoeopathy is found to be very effective in the treatment of allergic rhinitis. Studies show that homoeopathic medicines are superior in their action than placebo. Homoeopathy is based on the principle similia similibus curenter, that is medicines are selected based on individualization and the remedies selected based on this work very well. Dictionary of homoeopathic materia medica- 131 new Homoeotherapeutics by Dr O.A Julian shows that Galphimia glauca has herbal uses for a whole variety of allergic infections, also it shows that galphimia is effective for hay fever, vasomotor allergic rhinopathies and hypersecretion of the nasal mucus and ocular mucus, sneezing and hypersensitiveness to the change of weather in its pathogenesis. Homoeopathic remedy Galphimia glauca is found to be effective in the symptomatic treatment of allergic rhinitis and is superior than placebo without any adverse effects. Also effects of Galphimia glauca are comparable to those of antihistamines or other antiallergic agents as well. A randomised prospective study by Ernest shows that homoeopathic Galphimia glauca has effects of similar magnitude as conventional antihistamines, though no comparative studies have tested this hypothesis. Studies and homoeopathic literature show that Galphimia glauca is found to be effective in the treatment of allergic rhinitis with no adverse effects(10). But no relevant studies are conducted on the effectiveness of Galphimia glauca on allergic rhinitis since 1997. Also no intention to treat analyses (ITT) were reported in any of the randomized control trials. Also no validated outcome measures are used in most of the studies.So my effort is aimed to compare the effectiveness of Galphimia glauca with individualized homoeopathic medicines in allergic rhinitis using a validated outcome measure (TNSS- Total Nasal Symptom Score). |