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CTRI Number  CTRI/2024/07/070108 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A study to relieve the Symptoms of allergic rhinitis using constitutional medicine and assess the improvement using rhinitis control assessment test scale and absolute eosinophil count 
Scientific Title of Study   Effectiveness Of Homoeopathic Constitutional Medicine In Allergic Rhinitis By Assessing RCAT Scale And Absolute Eosinophil Count- A Prospective Study 
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 PRIYADHARSHINI S 
Designation  PG SCHOLAR 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  IIIrd Floor, College Building, Department Of Organon Of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam

Kanniyakumari
TAMIL NADU
629161
India 
Phone  7397024787  
Fax    
Email  spriya200216@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M MURUGAN 
Designation  PROFESSOR AND HOD 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  IIIrd Floor, College Building, Department Of Organon Of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443343707  
Fax    
Email  drmmuruganhomoeo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr M MURUGAN 
Designation  PROFESSOR AND HOD 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  IIIrd Floor, College Building, Department Of Organon Of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443343707  
Fax    
Email  drmmuruganhomoeo@gmail.com  
 
Source of Monetary or Material Support  
Institution -Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamil nadu, India, 629161  
 
Primary Sponsor  
Name  Post Graduate Research Funded By College 
Address  Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamil nadu 629161  
Type of Sponsor  Private medical college 
 
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 PRIYADHARSHINI S  Sarada Krishna Homoeopathic Medical College  Room No 403 Department of Organon Of medicine and Homoeopathic Philosophy,Kulasekharam Kanniyakumari, Tamil Nadu, 629161
Kanniyakumari
TAMIL NADU 
7397024787

spriya200216@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sarada Krishna Homoeopathic Medical College,Kulasekharam  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  Constitutional Homoeopathic Medicine  Individualised homoeopathic medicine will be given based on symptom similarity and considering the constitution of the patient The medicine will given for every 2 weeks 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients having symptomatology of allergic rhinitis.
Age group between 5 - 55 years.
Both sexes.
Patients without the complications of allergic rhinitis such as effusion formation in sinuses, edema of lids, cobble stone conjunctiva, serous otitis media, conductive hearing Loss, granular pharyngitis, bronchial asthma.
 
 
ExclusionCriteria 
Details  Patients suffering from other severe systemic diseases.
Cases in which surgical intervention becomes necessary.
Pregnant women or breast-feeding individuals may be excluded
Allergic rhinitis associated with any chronic and systemic disease on active treatment.
Exclude severe controlled diabetes.
Severe underlying medical conditions such as immunodeficiency disorders, autoimmune diseases or malignancies.
Patients with the complications of allergic rhinitis such as effusion formation in sinuses, edema of lids, cobble stone conjunctiva, serous otitis media, conductive hearing loss, granular pharyngitis, bronchial asthma. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement of symptoms of allergic rhinitis with constitutional homoeopathic medicine  6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
Symptomatic and general improvement in the condition of patients is evaluated using Rhinitis Control Assessment Test scale tool and Absolute Eosinophil Count.

 
6 MONTHS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 4 
Date of First Enrollment (India)   15/07/2024 
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 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 is the most common form of non-infectious rhinitis, affecting between 10% and 30% of all  adults  and as many as 40%  of children. This will be treated by conventional treatments like, antihistamines, corticosteroids, Immunotherapy, Anti IgE antibody therapy and nasal decongestants. According to Dr.Hahnemann, In 5th aphorism, he stated that chronic diseases has to be treated with constitutional medicine in order  to effect the cure and it should be based on the principles of homoeopathy. According to 2nd aphorism, The cure must be ideal, gentle and in rapid manner. Homoeopathy acts in both ways, as effective in relieving symptoms and also increase one’s resistance to cold and also strengthens the vital force and improve the quality of life. Various research studies on allergic rhinitis have been conducted previously and they were aimed at determining the effectiveness of homoeopathic medicines in the treatment of allergic rhinitis based on the assessment of Absolute eosinophil count and IgE levels. These studies focused either on specific medicines or on the Anti - miasmatic medicines. The results of these studies were relied either on a particular assessment scale or on a particular laboratory investigation. Thus, studies determining the efficacy of homoeopathic remedies selected based upon the constitution of the patients are less and if found are not recent. In addition to this, studies showing the simultaneous symptomatologic and lab parametric assessment of improvement in patients with allergic rhinitis are insignificant. Hence, this research study will focus on the effectiveness of homoeopathic constitutional medicine in allergic rhinitis by assessing the symptomatologic RCAT scale and parametric improvement through Absolute Eosinophil Count.  Improvement of the symptoms is assessed using Rhinitis Control Assessment Test Scale. Absolute Eosinophil Count Result before beginning of the treatment and after treatment is noted.

 


 
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