| CTRI Number |
CTRI/2025/09/095297 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homeopathic Treatment Of Migraine With Lac Vaccinum Defloratum |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Homoeopathic Medicine Lac Vaccinum Defloratum In The Management Of Migraine - Prospective Interventional Study Using MIDAS Score |
| 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. Astha Soni |
| Designation |
Md Scholar - Homeopathic Materia Medica |
| Affiliation |
Anand Homeopathic Medical College And Research Institute |
| Address |
Room No 210 Department of Homeopathic Materia Medica,
1st floor
Anand Homeopathic Medical College And Research Institute Nr Sardar Baug, Bhalej Road, Anand
Anand
GUJARAT
388001
India |
| Phone |
9824424308 |
| Fax |
|
| Email |
asthasoni1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bankim A Patel |
| Designation |
MD Homeopathy Associate Professor Department Of Homeopathic Materia Medica |
| Affiliation |
Anand Homeopathic Medical College And Research Institute |
| Address |
Room No 211 - Department Of Homeopathic Materia Medica - 1st Floor
Anand Homoeopathic Medical College And Research Institute Nr Sardar Baug, Bhalej Road, Anand
Anand
GUJARAT
388001
India |
| Phone |
9428066383 |
| Fax |
|
| Email |
pramukh.homeo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Bankim A Patel |
| Designation |
MD Homeopathy Associate Professor Department Of Homeopathic Materia Medica |
| Affiliation |
Anand Homeopathic Medical College And Research Institute |
| Address |
Room No 211 - Department Of Homeopathic Materia Medica,
1st Floor
Anand Homoeopathic Medical College And Research Institute Nr Sardar Baug, Bhalej Road
Anand
GUJARAT
388001
India |
| Phone |
9428066383 |
| Fax |
|
| Email |
pramukh.homeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anand Homeopathic And General Hospital,Anand - 388001, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Dr Astha Soni |
| Address |
36 - Alankar Tenament, TP 13, Chhani Jakatnaka, Vadodara-390002, Gujarat |
| 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 Astha Soni |
Anand Homeopathic And General Hospital |
Department Of Medicine OPD No 1 Room No 1
Opp Sardar Baug, Nr New Bus Stand, Anand - 388001
Anand
GUJARAT |
9824424308
asthasoni1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Anand Homeopathic Medical College And Research Institute |
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 |
Lac Vaccinum Defloratum |
Lac Vaccinum Defloratum, 4 globules orally in suitable potency as per susceptibility. Repetition based on susceptibility and symptom severity. Follow-up every 15 days or earlier if needed |
| Comparator Agent |
NOT APPLICABLE, as there
is no comparator agent |
As Lac Vaccinum Delforatum single medicine will
prescribe and it is a single arm study |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients Diagnosed With Migraine As Per ICHD-3
2.Patients Whose MIDAS Score Would Be Less Than 20
3.Patients Willing To Give Informed Consent And Comply With The Study Protocol |
|
| ExclusionCriteria |
| Details |
1. Patients With Secondary Headache Such As Due To Structural Brain Lesions
2. Pregnant Or Lactating Women
3. Patients Pursuing Other Treatment Or Not Willing To Leave It
4. Presence Of Severe Disability Such As MIDAS Score More Than 20 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Mean Change In MIDAS Score From Baseline |
Baseline (Week 0), 3rd month, 6th month, 9th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change In Intensity Of Pain
2.Change In Associated Symptoms Such As Nausea, Vomiting, Photophobia, Phonophobia |
Baseline (Week 0), 3rd month, 6th month, 9th month |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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 study will evaluate the effect of the homoeopathic medicine Lac Vaccinum Defloratum in patients suffering from migraine. The aim is to find out whether it helps in reducing headache frequency, intensity, and disability measured by the MIDAS score. A total of 50 participants will be enrolled, treated, and followed up for improvement and safety assessment. |