| CTRI Number |
CTRI/2025/08/092146 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Assess the Role of Individualized Homoeopathic Medicine in Cases of Allergic Rhinitis Considering Kents Twelve Observations at Follow Ups |
|
Scientific Title of Study
|
A Prospective Single Arm Interventional Study to Assess the Role of Individualized Homoeopathic Medicine in Cases of Allergic Rhinitis Considering Kents Twelve Observations at Follow Ups |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prerana Kulshrestha |
| Designation |
Post graduate resident |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
Opd Medicine 1 and 2 room number 29 and 30 10 A Sitapura Institutional Area Tonk Road Goner Road Sitapura Industrial Area Sitapura Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9457593589 |
| Fax |
|
| Email |
preranakulshrestha97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Bhatia |
| Designation |
Associate Professor |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
33 6132 Rangoli gardens Jaipur
Opd Medicine 1 and 2 room number 29 and 30 10 A Sitapura Institutional Area Tonk Road Goner Road Sitapura Industrial Area Sitapura Jaipur
Jaipur
RAJASTHAN
302034
India |
| Phone |
9549600600 |
| Fax |
|
| Email |
manish@hpathy.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Bhatia |
| Designation |
Associate Professor |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
33 6132 Rangoli gardens Jaipur
Opd Medicine 1 and 2 room number 29 and 30 10 A Sitapura Institutional Area Tonk Road Goner Road Sitapura Industrial Area Sitapura Jaipur
RAJASTHAN
302034
India |
| Phone |
9549600600 |
| Fax |
|
| Email |
manish@hpathy.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic Medical College and Research Centre
10 A Sitapura Institutional Area Tonk Road Goner Road Sitapura Industrial Area Sitapura Jaipur Rajasthan 302022 India |
|
|
Primary Sponsor
|
| Name |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
| Address |
10 A Sitapura Institutional Area Tonk Road Goner Road Sitapura Industrial Area Sitapura Jaipur |
| Type of Sponsor |
Research institution and 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 Manish Bhatia |
Swasthya Kalyan Homoeopathic Medical College and Research Centre |
Opd Medicine 1 and 2 room number 29 and 30 10 A Sitapura Institutional Area Tonk Road Goner Road Sitapura Industrial Area Sitapura Jaipur Rajasthan 302022
Jaipur
RAJASTHAN |
9549600600
manish@hpathy.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swasthya Kalyan Homoeopathic Medical College Institutional Ethics 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 |
Dose Potency and Repetition as per the susceptibility of patient and need of the case
Globule size used number 30
Oral route of administration
For 3 months |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
New cases of perennial allergic rhinitis
Patients giving consent to participate in study
|
|
| ExclusionCriteria |
| Details |
Cases diagnosed with severe epistaxis sinusitis asthma and gross pathological changes and complications
Pregnant females and lactating mothers will not be included in the study
Individuals who decline to provide consent for the research
Patients with seasonal rhinitis will not be included in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We anticipated that individualized homoeopathic medicine will lead to a significant reduction in allergic rhinitis symptoms and will improve overall quality of life |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study is expected to identify the most commonly occurring Kents observations in the follow up of allergic rhinitis cases treated with individualized homoeopathy thereby enhancing the practical understanding of these observations |
12 months |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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
|
This study is to assess the role of individualized homoeopathic medicine in cases of allergic rhinitis considering Kent’s Twelve Observations at follow ups. My objective is to assess the role of
individualized homoeopathic medicine in managing the clinical symptoms of
allergic rhinitis using Rhinitis Control Assessment Test Scale and to evaluate the follow-up responses using
Kent’s Twelve Observations. Expected outcome is to anticipate that individualized homoeopathic medicine will lead to a significant reduction
in allergic rhinitis symptoms and will improve overall quality of life and to
identify the most commonly occurring Kent’s observations in the follow-up of
allergic rhinitis cases treated with individualized homoeopathy, thereby
enhancing the practical understanding of these observations. The total participants in this study is 31 participants and this study will be done for 1 year. |