| CTRI Number |
CTRI/2025/10/095596 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Finding out which method works better for migraine homeopathic medicine taken as tiny pills or as liquid drops. |
|
Scientific Title of Study
|
A comparative experimental study to assess the efficacy of
administration of individualised homoeopathic medicine in solid
globule form and liquid dilution form in treatment
of migraine. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santoki Bhavik Lavjibhai |
| Designation |
MD Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
To: Badanpar Ta:Jodiya Dist: Jamnagar
B/H Jainath Petrol Pump Gondal Road Rajkot-360002
Rajkot
GUJARAT
361250
India |
| Phone |
9512294128 |
| Fax |
|
| Email |
bhaviksantoki1525@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Shroff |
| Designation |
Professor, Organon of medicine |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
4,Shakti park soc.
Opp catholic chruch
Karamsad 388325
Anand
B/H Jainath Petrol Pump Gondal Road Rajkot-360002
Rajkot
GUJARAT
388325
India |
| Phone |
9898930311 |
| Fax |
|
| Email |
drshroff3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Santoki Bhavik Lavjibhai |
| Designation |
MD Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
To: Badanpar Ta:Jodiya Dist: Jamnagar
B/H Jainath Petrol Pump Gondal Road Rajkot-360002
Rajkot
GUJARAT
361250
India |
| Phone |
9512294128 |
| Fax |
|
| Email |
bhaviksantoki1525@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College |
|
|
Primary Sponsor
|
| Name |
Sainath Hospital |
| Address |
B/H jainath petrol pump gondal road rajkot-360002 |
| 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 |
| Santoki Bhavik Lavjibhai |
Sainath Homoeopathic Hospital |
101 Medicine Department B/H Jainath Petrol Pump Gondal Road Rajkot 360002
Rajkot
GUJARAT |
9512294128
bhaviksantoki1525@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee For Human Research Rajkot Homoeopathic Medical College Parul university |
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 |
A comparative experimental study to assess the efficacy of
administration of individualised homoeopathic medicine in solid
globule form and liquid dilution form in treatment
of migraine. |
The study compares the efficacy of individualized Homoeopathic medicines administered in two dosage forms – solid globules and liquid dilutions – for the treatment of migraine. The investigation aims to determine differences in symptom relief, patient compliance, and overall treatment outcomes between the two forms. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of migraine based on International Classification of Headache Disorders
(ICHD-3).
Willing to give written informed consent.
Able to comply with research and follow ups. |
|
| ExclusionCriteria |
| Details |
Patients with other types of headache (tension-type, cluster, etc.).
Any Known psychiatric disorders
Pregnant or lactating women.
Participation in other study within the last 3 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in migraine-related disability or pain measured by MIDAS score. |
Baseline(Day 0)
Follow up every 15 days up to 12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in frequency and intensity of migraine attacks during the study period.
Patient compliance with prescribed mode of medicine administration (globule vs. liquid).
Patient satisfaction with treatment form assessed through feedback.
Recurrence rate of migraine episodes during the 12-month follow-up. |
Baseline (Day 0)
Follow-up every 15 days up to 12 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 2 |
|
Date of First Enrollment (India)
|
12/10/2025 |
| 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="0"
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 and disabling neurological disorder, often managed with Homoeopathy. Traditionally, medicines are given in solid globule form, but liquid dilution form is also widely used. This study aims to compare the effectiveness of individualized Homoeopathic medicines administered in solid globule versus liquid dilution forms in patients with migraine. A total of 50 patients (25 in each group) will be enrolled and randomized. Diagnosis will be based on ICHD-3 criteria. The primary outcome will be reduction in disability as measured by the Migraine Disability Assessment (MIDAS) score. Secondary outcomes will include frequency and intensity of attacks, patient compliance, satisfaction, and recurrence rates. The study duration is 12 months, with follow-ups every 15 days. The trial is expected to provide clinical evidence on whether the dosage form (globules or liquid dilution) influences therapeutic outcomes in migraine. |