| CTRI Number |
CTRI/2024/02/062940 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Analyzing the effectiveness of constitutional homoeopathic remedies in allergic rhinitis |
|
Scientific Title of Study
|
Constitutional approach of patients with allergic rhinitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V M Priyadarshini |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital Kulasekharam |
| Address |
Room no 403 Department of Organon of medicine and Homoeopathic philosophy Sarada Krishna Homoeopathic Medical College and Hospital
Kulasekharam
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9629670075 |
| Fax |
|
| Email |
priyadoc97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M Murugan |
| Designation |
Professor Head of the department Research guide |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital Kulasekharam |
| Address |
Room no 403 Department of Organon of medicine and Homoeopathic Philosophy Sarada Krishna Homoeopathic Medical College and Hospital
Kulasekharam
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443343707 |
| Fax |
|
| Email |
drmmuruganhomoeo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Murugan |
| Designation |
Professor Head of the department Research guide |
| Affiliation |
Sarada Krishna Homoeopathic Medical College and Hospital Kulasekharam |
| Address |
Room no 403 Department of Organon of medicine and Homoeopathic philosophy Sarada Krishna Homoeopathic Medical College and Hospital
Kulasekharam
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443343707 |
| Fax |
|
| Email |
drmmuruganhomoeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
V M Priyadarshini |
| Address |
Room no 403 Department of Organon of medicine and Homoeopathic philosophy Sarada Krishna Homoeopathic Medical college and Hospital |
| 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 V M Priyadarshini |
Sarada Krishna Homoeopathic Medical College and Hospital |
Room no 403 Department of Organon of medicine and Homoeopathic philosophy
Kanniyakumari
TAMIL NADU |
9629670075
priyadoc97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sarada Krishna Homoeopathic Medical College |
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 |
Constitutional Homoeopathic Medicine |
Individualised homoeopathic medicine will be given based on the symptom similarity and considering the constitution of the patient The medicine will given for every two weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Symptomatology of allergic rhinitis |
|
| ExclusionCriteria |
| Details |
1.Age below 5 and above 60 years.
2.Cases in which surgical intervention becomes necessary.
3.Allergic rhinitis associated with any chronic and systemic disease on active treatment.
4.Pregnant women
5. Patients suffering from other severe systemic diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of allergic rhinitis with constitutional homoeopathic medicine will be assessed using Rhinitis Control Assessment Test Scale |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement of symptoms of allergic rhinitis |
2 weeks |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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 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
|
This study will assess the effectiveness of constitutional medicine and will help in understanding the role of constitution in the treatment of allergic rhinitis. Allergic rhinitis is erroneously considered as trivial disease and it affects the quality of life and to treat the case most effectively constitutional homoeopathic medicine should be administered which improves the overall health of the patient |