| CTRI Number |
CTRI/2024/11/077377 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
understanding the role of homoeopathic medicines in cases of allergic rhinitis due to dust |
|
Scientific Title of Study
|
A Comparative study of Solanum Lycopersicum v/s Individualized Homoeopathic Medicine in Treatment of Allergic Rhinitis due to Dust |
| 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 Pathikkumar Jayeshbhai Patel |
| Designation |
PhD Scholar |
| Affiliation |
Vidhyadeep Homoeopathic Medical College and Research Centre |
| Address |
Room No.4 Vidhyadeep Homoeopathic Medical College and Research Centre Vidhyadeep University Anita Kim
Surat
GUJARAT
394110
India |
| Phone |
8905934257 |
| Fax |
|
| Email |
pathikpatel199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pathikkumar Jayeshbhai Patel |
| Designation |
PhD Scholar |
| Affiliation |
Vidhyadeep Homoeopathic Medical College and Research Centre |
| Address |
Room No.4 Vidhyadeep Homoeopathic Medical College and Research Centre Vidhyadeep University Anita Kim
Surat
GUJARAT
394110
India |
| Phone |
8905934257 |
| Fax |
|
| Email |
pathikpatel199@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vipul R Shastri |
| Designation |
Principal of VHMC and RC,I/C provost of Vidhyadeep University,PhD Guide |
| Affiliation |
Vidhyadeep Homoeopathic Medical College and Research Centre |
| Address |
Room No.4 Vidhyadeep Homoeopathic Medical College and Research Centre Vidhyadeep University Anita Kim
Surat
GUJARAT
394110
India |
| Phone |
9824109174 |
| Fax |
|
| Email |
drvipulshastri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No.4 Vidhyadeep Homoeopathic Medical College and Research Centre Vidhyadeep University Anita Kim Surat Gujarat 394110 India |
|
|
Primary Sponsor
|
| Name |
Vidhyadeep Homoeopathic Medical College and Research Centre |
| Address |
Vidhyadeep University Anita Kim Surat Gujarat 394110 India |
| Type of Sponsor |
Other [This is Homoeopathic Medical College And Research Centre Along With Hospital] |
|
|
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 Pathikkumar Jayeshbhai Patel |
Vidhyadeep Homoeopathic Medical College and Research Centre |
Room No.4,Homoeopathy Dept.,Vidhyadeep Homoeopathic Medical College and Research Centre,Vidhyadeep University,Anita,Kim 394110
Surat
GUJARAT |
8905934257
pathikpatel199@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 medicine Solanum lycopersicum |
Solanum lycopersicum will be administered in cases of allergic rhinitis caused by dust, with follow-up assessments scheduled every 3, 7, or 15 days, or as needed, using the Visual Analogue Scale (VAS) to evaluate progress at the end of 3 months. |
| Comparator Agent |
Individualized homoeopathic medicine |
Individualized medicines like Ars alb, Silicea, Psorinum, Pothos etc will be selected based on the symptoms and follow-up assessments will be scheduled every 3, 7, or 15 days, or as necessary, to monitor progress. The Visual Analogue Scale (VAS) will be used to evaluate improvements at the end of 3 months. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Cases with allergic rhinitis mainly due to dust allergy will be selected irrespective of age and gender.
Known Cases of allergic rhinitis with positive history of dust allergy
Cases with positive skin prick test for dust allergy.
|
|
| ExclusionCriteria |
| Details |
Cases without dust allergy or cases with another allergy
Cases with other co- existing severe systemic illness
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Using the Visual analogue Score (VAS) |
Baseline,12 Weeks or At End Of Treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Individualized homoeopathic medicines will prove more effective in management of allergic rhinitis occurring due to dust in compare to Solanum lycopersicum.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/12/2024 |
| 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="1"
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
|
Cases of allergic rhinitis are increasing in India. Among different allergens dust is the most common problem in India. There is no solution with conventional treatment but homoeopathic treatment increases immunity against allergens. Homoeopathic medicine Solanum lycopersicum is one of the useful medicine for allergic rhinits due to dust but Individualized homoeopathic medicines are also playing important role in management of allergic rhinits too. So this study is taken up to identify the usefulness of Solanum lycopersicum against individualizing homoeopathic medicines. |