| CTRI Number |
CTRI/2025/11/098000 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY ON EPIPHEGUS VIRGINIANA 30C TO REDUCE DISABILITY CAUSED BY MIGRAINE |
|
Scientific Title of Study
|
A CLINICAL STUDY TO ASSESS THE EFFICACY OF EPIPHEGUS VIRGINIANA 30C IN REDUCING MIGRAINE - RELATED DISABILITY USING THE MIDAS 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. Sanha |
| Designation |
PG Scholar |
| Affiliation |
AM Shaikh Homoeopathic Medical College And Hospital Belgaum |
| Address |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Homoeopathic Materia Medica, Ground Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9844184721 |
| Fax |
|
| Email |
sanhak80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Afshan Balekundri |
| Designation |
Professor And PG Guide |
| Affiliation |
AM Shaikh Homoeopathic Medical College And Hospital Belgaum |
| Address |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Homoeopathic Materia Medica, Ground Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9341493285 |
| Fax |
|
| Email |
afshanatharbalekundri@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sanha |
| Designation |
PG Scholar |
| Affiliation |
AM Shaikh Homoeopathic Medical College And Hospital Belgaum |
| Address |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Homoeopathic Materia Medica, Ground Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9844184721 |
| Fax |
|
| Email |
sanhak80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sanha
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Homoeopathic Materia Medica, Ground Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India - 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Sanha |
| Address |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Homoeopathic Materia Medica, Ground Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India - 590010 |
| 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 Sanha |
AM Shaikh Homoeopathic Medical College And Hospital Belgaum |
AM Shaikh Homoeopathic Medical College, PG Research Centre And Hospital, Department Of Homoeopathic Materia Medica, Ground Floor, PG Section, Shaikh Campus, Nehru Nagar, Belagavi, Karnataka, India - 590010
Belgaum
KARNATAKA |
9844184721
sanhak80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL CLEARANCE FOR RESEARCH STUDY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G437||Chronic migraine without aura, (2) ICD-10 Condition: G431||Migraine with aura, (3) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epiphegus Virginiana 30C Homeopathic Remedy |
The intervention involves the administration of Epiphegus Virginiana 30C, a homoeopathic remedy, to individuals suffering from migraine-related disability; one dose at interval of 7 days for the period of 3 months to 6 months as per requirement of the case. The treatment aims to reduce the frequency, intensity, and disability associated with migraines, as measured by the MIDAS (Migraine Disability Assessment) Scale. The remedy will be administered in oral pellet form, with the patient dissolving the pellets under the tongue. The dosage regimen may involve taking a single dose or repeated doses depending on the severity and clinical judgment. The precise dosage and frequency will be determined on an individual basis, typically tailored to the patients migraine pattern. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age groups between 18-60 years.
Pre-diagnosed cases of migraine with history. |
|
| ExclusionCriteria |
| Details |
Cases of headache other than migraine.
Patients who are under any other medications for migraine (e.g., long-term prophylactic anti-migraine allopathic treatment) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in MIDAS score by 10 or more points, as measured using the Migraine Disability Assessment Scale (MIDAS) |
Baseline (Day 0) & Last Followup (Day 180) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
13/01/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Null Hypothesis: Epiphegus Virginiana 30C has no significant effect on reducing migraine-related disability as measured by the MIDAS Scale.
Alternative Hypothesis: Epiphegus Virginiana 30C significantly reduces migraine-related disability as measured by the MIDAS Scale.
Aim: The aim of this study is to evaluate the efficacy of Epiphegus Virginiana 30C in reducing migraine-related disability, as measured by the MIDAS (Migraine Disability Assessment) Scale.
Objectives: To assess the effectiveness of Epiphegus Virginiana 30C in the management of migraines. To measure improvements in migraine-related disability using the MIDAS Scale.
Source of Data: Study participants will be recruited from the OPD (Outpatient Department), peripheral OPD, and IPD (Inpatient Department) of A.M. Shaikh Homoeopathic Medical College, Hospital, and Post Graduate Research Centre, Belagavi.
Type of Research: This is a prospective interventional single-arm clinical study.
Sampling Technique and Method: The study will use a purposive, non-probability sampling method.
Selection Criteria: Participants will be selected based on criteria supported by the International Headache Society (IHS).
Duration of Study: All selected subjects will be enrolled within 15 months.
Tools Used in Study: Standard case proforma. Informed consent form. MIDAS Questionnaire to assess migraine-related disability.
Inclusion Criteria: Participants aged 18–60 years. Diagnosed with migraine and having a history of the condition.
Exclusion Criteria: Patients with headaches other than migraine. Those currently undergoing long-term allopathic migraine treatment or using other anti-migraine medications.
Remedy Prescription Criteria: All 36 cases will be treated with Epiphegus Virginiana 30C, prescribed according to the acute or sector totality of the case.
Follow-Up: Follow-up will be conducted every month for a period of 3 to 6 months, based on the requirements of the individual case.
Result Criteria: An improvement will be defined as a reduction of 10 or more points in the MIDAS score, indicating a significant decrease in migraine-related disability.
This study aims to assess whether Epiphegus Virginiana 30C offers a viable homeopathic treatment option for reducing the impact of migraines on daily functioning.
|