| CTRI Number |
CTRI/2025/08/093493 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Homoeopathic Medicines in the treatment of migraine and a comparative analysis of it using different scales assessed by Midas score : Placebo Controlled Trial |
|
Scientific Title of Study
|
Efficacy of Homoeopathic Medicines in the treatment of migraine and a comparative analysis of it using centesimal scale and 50 millesimal scale assessed by Midas score : Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASHWINI PATIL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
|
| Address |
Department of Organon of Medicine,
Hon R R PATIL COLLEGE OF HOMOEOPATHY AND HOSPITAL BY PASS ROAD SANGLI
Sangli
MAHARASHTRA
416416
India |
| Phone |
9766060502 |
| Fax |
|
| Email |
dr.ashwinipatil24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhas L Patil |
| Designation |
Professor and Guide |
| Affiliation |
SJPES Homoeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine
Ground Floor SJPES Homoeopathic Medical College and Hospital, 200 E, Tararani Chowk, Kolhapur
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9421288470 |
| Fax |
|
| Email |
suhas_20august@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
ASHWINI PATIL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Hon R R PATIL COLLEGE OF HOMOEOPATHY AND HOSPITAL |
| Address |
Department of Organon of Medicine
Hon R R PATIL COLLEGE OF HOMOEOPATHY AND HOSPITAL
BY PASS ROAD SANGLI
Sangli
MAHARASHTRA
416416
India |
| Phone |
9766060502 |
| Fax |
|
| Email |
dr.ashwinipatil24@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ASHWINI PATIL |
| Address |
Department of Organon of Medicine,
Hon R R PATIL COLLEGE OF HOMOEOPATHY AND HOSPITAL BY PASS ROAD SANGLI |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suhas Laxman Patil |
SJPES Homoeopathic Medical College and Hospital |
Department of Organon of Medicine, Ground Floor, 200 E, Tararani Chowk, Kawala Naka, Kolhapur
Kolhapur
MAHARASHTRA |
9421288470
suhas_20august@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Report |
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 |
Indicated Homoeopathic Medicine |
Indicated Homoepathic Medicine - orally 4 pills two times a day for 15 days |
| Comparator Agent |
Indicated Homoepathic medicines given in either centesimal scale or 50 millesimal scale |
Indicated Homoepathic Medicine - orally 4 pills two times a day for 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 18 to 70 yr
2. Patients of all the sexes.
3. Patients presenting clinical features of Migraine
4. All Socio-economical strata will be considerd |
|
| ExclusionCriteria |
| Details |
1. Patient suffering from Hyperacidity or Gastritis.
2. Patients with complications of Migraine.
3. Patient suffering from life threatenging or chronic conditions or immunocompromised.
4. Patient taken another prior medication for Migraine of same episode.
5. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be based on the reduction in the number of Symptom Severity Score Scale. |
Base line thereafter end of every three months for one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
03/09/2025 |
| 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="3"
Months="0"
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
|
This study aims to assess the efficacy of Homoeopathic medicines in the tratment of migraine using different scales. Migraine is a common neurological disorder disabling primary headache.
In this randomazed controlled trial, 80 patients between age 18 to 70, dignose with migraine were divided into two groups. First group A received centesimal scale individulized Homoeopathic medicines and another group B received 50 millesimal scale individulized Homoepathic medicines. Patients monitor over period of time using both the scales to evaluate the reduction in the number of symptoms severity score scale.
The study seeks to expolore wether Homoepathic medicines are effective in the treatment of migraine using different scales. |