| 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
|
|
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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
|
|
|
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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