| CTRI Number |
CTRI/2024/05/067772 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Understand the Fundamental cause & effectiveness Of Homoeopathic Treatment in cases of Allergic Rhinitis |
|
Scientific Title of Study
|
To understand the Miasmatic background and effectiveness of homoeopathic treatment in cases of 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 |
DR BHUMIKAKUMARI S GAMIT |
| Designation |
MD Student |
| Affiliation |
Dr V H Dave Homoeopathic Medical College |
| Address |
Dr.V.H Dave Homoeopathic Medical College, Hahnemann House,Amul Dairy Road, Anand -388001
Surat
GUJARAT
394635
India |
| Phone |
9978116835 |
| Fax |
|
| Email |
bhumigamit97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHIRAG TAMBOLI |
| Designation |
Professor |
| Affiliation |
Dr V H Dave Homoeopathic Medical College |
| Address |
Dr V H Dave Homoeopathic Medical College
Hahnemann House
Amul Dairy Road
Anand
Anand
GUJARAT
388001
India |
| Phone |
9428489176 |
| Fax |
|
| Email |
drchiragtamboli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CHIRAG TAMBOLI |
| Designation |
Professor |
| Affiliation |
Dr V H Dave Homoeopathic Medical College |
| Address |
Dr V H Dave Homoeopathic Medical College
Hahnemann House
Amul Dairy Road
Anand
GUJARAT
388001
India |
| Phone |
9428489176 |
| Fax |
|
| Email |
drchiragtamboli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peripheral OPD at Health Centre of Anand Agricultural University |
| Smt S I Patel (Ipcowala) Homoeopathic Hospital Amul Dairy Road Anand 388001 |
|
|
Primary Sponsor
|
| Name |
Dr Bhumikakumari S Gamit |
| Address |
At post Pati,Mishan Faliyu
Taluka Dolvan
District Tapi-394635 |
| 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 |
| Bhumikakumari S Gamit |
Smt.S.I. Patel (Ipcowala) Homoeopathic Hospital |
Dr V.H.Dave Homoeopathic Medical College, Amul Dairy Road, Anand.
Anand
GUJARAT |
9978116835
bhumigamit97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECVHDHMC |
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 |
Homoeopathic Remedy |
The symptoms will be analysed & evaluated.Totality of symptoms will be formed & compared with Homoeopathic medicines.Potency of medicine will be selected depending upon the susceptibility of the patients.case will be reviewed every 7-15 days & then depending upon the requirement of the cases. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Prediagnosed cases or cases with clinical presentation of the Allergic Rhinitis.
Cases with functional changes or with reversible pathology.
Those patients already on allopathic treatment,but now convinced to take Homoeopathic treatment. |
|
| ExclusionCriteria |
| Details |
Cases with severe systemic disease and irreversible pathology.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Score For Allergic Rhinitis is validated questionnaire introduce in 2002 by the Annesi-Maesano group |
As per requirement of cases till 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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
|
As I’ve observed prevalence of Allergic Rhinitis , probable adverse effects of allopathic management,the homoeopathic view for its probable causation (miasmatic)& its possible management with homoeopathic medicines -this study aims to understanding the Miasmatic background and its therapeutic implication in management of cases of Allergic Rhinitis, through a broader aspect, taking into consideration the holistic approach of Homoeopathy and provide gentle relief/cure. |