| CTRI Number |
CTRI/2025/11/097335 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
treatment of acute attack of migraine with giving medicine by smelling method |
|
Scientific Title of Study
|
Role of Route of Administration of Homoeopathic Medicine by Olfaction in Pain Management of Acute Attack of Migraine among Age Group 18–50 Years Using 11-Point Pain Scale: A Prospective Experimental Study |
| 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 Sagar Modi |
| Designation |
PG scholar |
| Affiliation |
Smt AJ Savla homeopathic medical college and research institute |
| Address |
room number 6 department of medicine ground floor Smt AJ Savla homeopathic medical college and research institute Pushpanjali building near district session court Mahesana Gujarat
Mahesana
Gujarat
Mahesana
GUJARAT
384001
India |
| Phone |
9537257711 |
| Fax |
|
| Email |
sagarmody27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Desai |
| Designation |
professor PG department of organon of medicine and philosophy |
| Affiliation |
Smt AJ Savla homeopathic medical college and research institute |
| Address |
room number 6 department of medicine ground floor Smt AJ Savla homeopathic medical college and research institute Pushpanjali building near district session court Mahesana Gujarat
Mahesana
Gujarat
Mahesana
GUJARAT
384001
India |
| Phone |
9429545666 |
| Fax |
|
| Email |
dranandivb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Modi |
| Designation |
PG Scholar |
| Affiliation |
Smt AJ Savla homeopathic medical college and research institute |
| Address |
room number 6 department of medicine ground floor Smt AJ Savla homeopathic medical college and research institute Pushpanjali building near district session court Mahesana Gujarat
Mahesana
Gujarat
Mahesana
GUJARAT
384001
India |
| Phone |
9537257711 |
| Fax |
|
| Email |
sagarmody27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt AJ Savla homeopathic medical college and research institute Pushpanjli building near district session court Mahesana Gujarat
|
|
|
Primary Sponsor
|
| Name |
Dr Sagar Modi |
| Address |
Room 6 department of medicine ground floor Smt AJ Savla homeopathic medical college and research institute Pushpanjli building near district session court Mahesana Gujarat
|
| Type of Sponsor |
Other [own 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 sagar modi |
Smt AJ Savla homeopathic medical college and research institute |
Smt AJ Savla homeopathic medical college and research institute Pushpanjli building near district session court Mahesana Gujarat
Mahesana
GUJARAT |
9537257711
sagarmody27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMT AJ Savla homeopathic medical college institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualies homeopathic medicine |
Intervention of homeopathic medicine through olfaction route and remedy will be selected as per the severity susceptibility of the patient in centesimal potency and repetation of medicine will be done every 10 min and observation till 2 hours |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient having 4 to 10 score according to 11 point pain scale
Diagnostic criteria fulfilling the migraine with ICHD 3 as mentioned in review of literature
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactation women
Known cases of brain abscesses or encephalitis aneurysms stroke tumor |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in 11 point pain scale |
Data assessment will be done before during and after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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
|
Migraine is a common neurological disorder characterized by recurrent attacks of moderate to severe headache often accompanied by nausea, vomiting, photophobia, and phonophobia. The present study aims to evaluate the role of route of administration of homoeopathic medicine by olfaction in the pain management of acute migraine attacks among individuals aged 18–50 years, using the 11-point pain scale as an outcome measure. This prospective experimental study will be conducted at Smt. A.J. Savla Homoeopathic Medical College and Research Institute, Mehsana, on 20 randomly selected cases fulfilling ICHD-3 diagnostic criteria. Individualized homoeopathic medicines in centesimal potency will be administered through the olfaction route, and pain intensity will be assessed before and after intervention. Data will be analyzed using descriptive statistics and paired t-test. The study seeks to determine the rapidity and effectiveness of the olfaction route in reducing migraine pain and to identify commonly indicated remedies and potencies useful in acute migraine management. |