| CTRI Number |
CTRI/2025/09/095377 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effectiveness of homoeopathic medicine given through smell and by mouth in patients with acute rhinitis” |
|
Scientific Title of Study
|
A comparative study to assess the effectiveness of administration of homoeopathic medicine through olfactory route versus oral route in Acute 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 Pinalkumari chetanbhai chaudhari |
| Designation |
M.D. Scholar |
| Affiliation |
Anand Homoeopathic Medical and Research institute, Anand |
| Address |
Room no 212 First floor,Department of Organon of Medicine, Anand homoeopathic Medical college and Research institute and Anand Homoeopathic hospital Near sardar Baug, Bhalej road
Anand
GUJARAT
388001
India |
| Phone |
9638713261 |
| Fax |
|
| Email |
chaudhripinal1305@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupal Mehta |
| Designation |
Professor, M.D (Organon of Medicine And Homoeopathic Philosophy) |
| Affiliation |
Anand Homoeopathic Medical and Research institute, Anand |
| Address |
Room no 212, First floor ,Department of Organon of medicine, Anand homoeopathic Medical college and Research institute and Anand Homoeopathic hospital Near sardar Baug, Bhalej road
Anand
GUJARAT
388001
India |
| Phone |
7600020410 |
| Fax |
|
| Email |
dr.rupalmehta9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pinalkumari chetanbhai chaudhari |
| Designation |
M.D. Scholar |
| Affiliation |
Anand Homoeopathic Medical and Research institute, Anand |
| Address |
Room no.212,first floor,Department of Organon of Medicine, Anand homoeopathic Medical college and Research institute and Anand Homoeopathic hospital Near sardar Baug, Bhalej road
Anand
GUJARAT
388001
India |
| Phone |
9638713261 |
| Fax |
|
| Email |
chaudhripinal1305@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anand Homoeopathic Hospital near Sardar Baug,Bhalej road,Anand 388001,Gujrat, India |
|
|
Primary Sponsor
|
| Name |
Dr. Pinalkumari Chetanbhai Chaudhari |
| Address |
At- kalavyara, Dankuva Faliyu, Po-Ghasiyamedha, Vyara 394360,Tapi |
| 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 Pinalkumari Chetanbhai Chaudhari |
Anand Homoeopathic Hospital,Anand |
Ground floor,Opd -1,room no.1 Department of Homoeopathic Medicine Near sardar Baug, Bhalej Road Anand, 388001
Anand
GUJARAT |
9638713261
chaudharipinal1305@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: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualise Homoeopathic Medicine Through Olfaction route |
Olfaction’ means ‘Act of Smelling’
For this, globules (or a single globule) are moistened with the medicinal fluid and placed dry in a small phial. The homeopathic physician allows the patient to hold the open mouth of phial first in one nostril, and, in the act of inspiration, draw the air out of it into himself.If both the nostrils are stopped up by coryza or polypus, the patient should inhale by the mouth holding the orifice of the phial between the lips |
| Comparator Agent |
Individualise Homoeopathic medicine Through Oral Route |
Homoeopathic potentised medicines are absorbed directly from the mouth and then act through the cerebro-spinal or ganglionic nervous system. Sub-lingual administration will be done.medicated globules administered through oral. |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age above 10 year and age below 80 year,all gender will be included in my study.
2.patient who suffer from from Acute rhinitis(All type of acte rhinitis) will included in my study.
3.Patient who are willing and are able to comply with study protocol,including taking homoeopathic treatment, attending follow-up. |
|
| ExclusionCriteria |
| Details |
1.Age below 10 year and above 80 year will excluded.
2.Pregnant and lactating women will excluded.
3.Patient who had left during treatment will be excluded.
4.Patient who unwilling to comply with the study protocol will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in symptoms of acute rhinitis through olfactory faster than Oral administration of homoeopathic medicine. |
Based on Acute Rhinitis symptoms score scale,and effectiveness of route will compare by onset of action of medicine and duration of relief |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical improvement in acute rhinitis symptoms (nasal discharge, sneezing, nasal obstruction, sore throat, general malaise) measured by change in Acute Rhinitis Symptom Score |
Based on Acute rhinitis symptoms score scale |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/10/2025 |
| 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="1"
Months="6"
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 prospective interventional comparative study aims to evaluate the effectiveness of homoeopathic medicines administered through the olfactory route versus the oral route in patients with acute rhinitis. Sixty patients above 10 years of age will be enrolled from the OPDs and camps of Anand Homoeopathic Hospital and randomly divided into two groups: olfactory route (n=30) and oral route (n=30). Remedies will be prescribed on the basis of totality of symptoms, and improvement will be assessed using the Acute Rhinitis Symptom Score Scale (ARSS) at baseline and follow-up visits. The study duration will be 18 months, with regular follow-ups every 5–15 days. Outcomes will be analyzed statistically using paired t-test to compare onset of action, duration of relief, and overall effectiveness between the two routes. |