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CTRI Number  CTRI/2024/07/070682 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 06/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy
Other (Specify) [Randomised clinical ]  
Study Design  Other 
Public Title of Study   A Clinical Study To Ascertain Role of Homoeopathic Medicines in Allergic Rhinitis in Children Using by Use of Synthesis Repertory. 
Scientific Title of Study   A Clinical Study To Ascertain The Role Of Homoeopathic Medicine In Cases Of Allergic Rhinitis In Children using the Synthesis Repertory and Construction of Repertoty of Causative Factors and Modalities Using Allens Keynotes and Characteristics of The Materia Medica by Dr. H.C.Allen. 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Savitri Laxmanbhai Chavda 
Designation  PG scholar 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Department of Case Taking and Repertory,Rajkot Homoeopathic Medical College,B/H jainath complex, makkam chowk, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  7069303484  
Fax    
Email  savitrichavda20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Kashyap Premsawala 
Designation  professor  
Affiliation  Rajkot Homoeopathic Medical College,parul University  
Address  Department of Case taking and Repertory, Rajkot Homoeopathic Medical Collage,B/H Jainath Complex,Rajkot.

Rajkot
GUJARAT
360002
India 
Phone  9727173799  
Fax    
Email  k2krp@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Savitri Laxmanbhai Chavda 
Designation  PG scholar 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Department of Case Taking and Repertory, Rajkot Homoeopathic Medical College,B/H jainath complex, makkam chowk, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  7069303484  
Fax    
Email  savitrichavda20@gmail.com  
 
Source of Monetary or Material Support  
Department of Case taking and Repertory,Rajkot Homoeopathic Medical College,B/H Jainath complex, Makkam Chowk, Rajkot.pin: 360002 
 
Primary Sponsor  
Name  Rajkot Homoeopathic Medical College  
Address  Department of case taking and Repertory,Rajkot Homoeopathic Medical College,B/H jainath complex, Makkam chowk, Rajkot pin:360002 
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 
DrSavitri Chavda  Sainath Homoeopathic Hospital  Department of case taking and Repertory,Rajkot Homoeopathic Medical College,B/H jainath complex, Makkam chowk, Rajkot,360002
Rajkot
GUJARAT 
7069303484

savitrichavda20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for human research -rajkot homoeopathic medical College,parul University.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine.  Individualized Homoeopathic Medicine selected by Synthesis Repertory Mode of administration is Oral Route. Individualized Medicine will be prescribe in 30,200,1m potency. Total duration of Study is 12 months. 
Comparator Agent  Nill  Nill 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Perennial and seasonal Allergic rhinitis patients.
Cases of pediatric age group 2- 18 years
Cases of both the sexes, irrespective of religion and caste.
Patient who will give consent to participant in the study.
Pre-diagnosed cases of allergic rhinitis which fulfilling history and physical finding of allergic causes.
 
 
ExclusionCriteria 
Details  Age below 2 and more than 18 years.
Patients have associated complaints or disease like asthma, nasal polyps, sinusitis and middle ear infections and end stage diseased condition.
Patients with allergic rhinitis who are on therapeutic measures of other disciplines.
Pregnancy and lactating mother.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There will be improvement after prescribing Homoeopathic Medicine.   This will be achieved in upcoming 9 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Significant improvement & sense of well being without complications & no relapse of symptoms.  This will be achieved in upcoming 9 months.  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   27/07/2024 
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="0"
Months="9"
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 is known to be a major cause of difficulty and disability especially affecting children. It is reported to affect approximately 25 & 40% of children and adult globally, respectively.
 In conventional system of medicine, they usually give anti- allergic or anti- inflammatory medicines but side effects of these medicines are drowsiness, dizziness, constipation, blurred vision, dry mouth; gives only short relief of the symptoms.                                                                                                                                                          
 On the other hand, Homoeopathy treats the patient as a whole individual; where Similimum is administered on individuality, in minimum dose. Homoeopathic medicines can be effective as it can annihilate the disease condition of an individual as well as their tendency of recurrence.
            I intend to carry out study, efficacy of homoeopathic medicines will be selected on basis of the essential synthesis repertory by Dr.Frederik Schroyens in cases with allergic rhinitis in children.
Homoeopathic philosophy teaches the reason for diseases in an entirely different way than of other system of medicines.
  Further, I intend to construct especially design repertory “ Repertory of Causative factor and Modalities” as a reference book from Allen’s keynotes and characteristics of the materia medica by Dr.H.C.Allen(10th edition). as this keynotes are very useful in practice and for students but there is no such repertory available which has exclusively rubrics formed using it and that too including causative factors and modalities. This repertorial data in my opinion would serve a great deal in choice of remedy for practitioners using Allen’s keynotes.
 Especially design repertory, use as a reference it will be arrange in alphabetical order and gradations and the importance of each symptom in every medicine described in Allen’s keynotes and characteristics of the materia medica. (10th edition).


 
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