| CTRI Number |
CTRI/2025/10/095810 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Wyethia helenoides and constitutional homoeopathic medicine in treating allergic rhinitis in adults aged 18–40 years using the TNSS scale |
|
Scientific Title of Study
|
A Prospective Study to Compare the Role of Wyethia Helenoides and Constitutional Homoeopathic Remedies in Cases of Allergic Rhinitis in Adults Aged 18–40 Years Using TNSS Scale |
| 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 Nandini Goswami |
| Designation |
Student |
| Affiliation |
Rajkot homoeopathic medical college |
| Address |
101-Department Of Medicine
Rajkot Homoeopathic Medical College
Near makkam chowk gondal road
Rajkot
GUJARAT
360002
India |
| Phone |
9904468842 |
| Fax |
|
| Email |
2404092060003@paruluniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kamna umesh Gupta |
| Designation |
Associate professor |
| Affiliation |
Rajkot homoeopathic medical college |
| Address |
Department of Homoeopathic Materia Medica
Rajkot homoeopathic medical college near makkam chowk,Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9029147800 |
| Fax |
|
| Email |
drkamnagupta@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandini Goswami |
| Designation |
Student |
| Affiliation |
Rajkot homoeopathic medical college |
| Address |
Shiv- shakti near rangila hanuman temple sahkar main road Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9904468842 |
| Fax |
|
| Email |
2404092060003@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Rajkot homoeopathic medical college
Near makkam chowk India 360001 |
|
|
Primary Sponsor
|
| Name |
SAINATH HOSPITAL |
| Address |
GONDAL ROAD NEAR MAKKAM CHOWK, RAJKOT. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| NANDINI GOSWAMI |
SAINATH HOMOEOPATHIC HOSPITAL |
101, DEPARTMENT OF MEDICINE,
GONDAL ROAD, NEAR MAKKAM CHOWK, RAJKOT
Rajkot
GUJARAT |
9904468842
2404092060003@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESERCH - RAJKOT HOMOEOPATHIC MEDICAL COLLEGE [RHMC, PARUL UNIVERSITY, GuJRAT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
LEVEL 4 J30.4 SELECT FOR ALLERGIC RHINITIS UNSPECIFIED
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Constitutional homoeopathic medicine
|
Medicine will be given in single dose or requirement of caseby oral root |
| Intervention |
Wyethia helenoids |
Medicine will be given in single dose or requirement of case by oral root |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age 18–40 years both female and male included
Diagnosed case under treatment controlled but wants to take homoeopathy
Already taken other medicine but not cured or relapse again Willingness to participate and comply with regular follow up schedules not undergoing any other simultaneous therapy for allergic rhinitis |
|
| ExclusionCriteria |
| Details |
Below 18 years and above 40 years
Known systemic autoimmune or immune deficient
Conditions patients on immunosuppressive therapy pregnant or lactating women unwilling or non cooperative participants patients with associated complaints or any systemic disease like diabetes mellitus asthma nasal polyp severe uncontrollable hypertension sinusitis middle ear infection
Those who cannot commit to regular follow up during the study period |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total nasal symtoms score
|
Every 1 week or as per requirement of cases till 7 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of treatment response patient satisfaction & safety throughout the study period |
Assessments at baseline & at each follow up visit as per case requirement for a duration of up to 7 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/10/2025 |
| 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="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
|
THIS STUDY IS A PROSPECTIVE COMPARATIVE ANALYSIS INVOLVING 50 PATIENTS WITH ALLERGIC RHINITIS DIVIDED INTO TWO GROUPS ONE RECEIVING WYETHIA HELENOIDES AND THE OTHER RECEIVING CONSTITUTIONAL HOMEOPATHIC MEDICINES BASED ON INDIVIDUAL CASE TAKING TREATMENT EFFECTIVENESS WILL BE MONITORED USING THE TOTAL NASAL SYMPTOM SCORE TNSS WITH REMEDIES AND POTENCIES SELECTED AS PER CASE REQUIREMENTS FOLLOW UP WILL BE CONDUCTED EVERY ONE WEEK OR AS PER CASE NEED UP TO 7 MONTHS AND STATISTICAL ANALYSIS USING THE PAIRED t TEST WILL COMPARE PRE AND POST TREATMENT OUTCOMES WITHIN EACH GROUP
WYETHIA HELENOIDES IS INCLUDED IN THIS STUDY TO DETERMINE ITS VALUE IN THE MANAGEMENT OF ALLERGIC RHINITIS THROUGH ITS HOMEOPATHIC ACTION ON THE RESPIRATORY MUCOUS MEMBRANES THE STUDY AIMS TO COMPARE ITS THERAPEUTIC VALUE WITH CONSTITUTIONAL HOMEOPATHIC TREATMENT IN ALLERGIC RHINITIS
|