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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  
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 
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  
Status 
Not Applicable 
 
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).
 
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