| CTRI Number |
CTRI/2026/02/103315 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on how personalized Homoeopathic treatment affects Quality of life of people suffering from Migraine. |
|
Scientific Title of Study
|
Exploring the Role of indicated Homoeopathic Medicine on Quality of life assessed by Migraine-specific quality of life questionnaire version 2.1 (MSQ) scale among Migraine patients – an Uncontrolled 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 Shalini Mukhdeo Prasad Sharma |
| Designation |
PhD Scholar |
| Affiliation |
Dr. M. L. Dhawale Memorial Homoeopathic Institute |
| Address |
Department of Practice of Medicine, 2nd floor, Dr.M.L.Dhawale Memorial Homoeopathic Institute, Opposite ST Workshop, Boisar Road, Palghar
Palghar
MAHARASHTRA
401404
India |
| Phone |
9325116836 |
| Fax |
|
| Email |
dr.shalinisharma2111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shama Manoj Rao |
| Designation |
Professor, Department of Practice of Medicine |
| Affiliation |
Dr. M.L. Dhawale Memorial Homoeopathic Institute |
| Address |
Department of Practice of Medicine, 2nd floor, Dr.M.L.Dhawale Memorial Homoeopathic Institute, Opposite ST Workshop, Boisar Road, Palghar
Palghar
MAHARASHTRA
401404
India |
| Phone |
9892212843 |
| Fax |
|
| Email |
rao.shama@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalini Mukhdeo Prasad Sharma |
| Designation |
PhD Scholar |
| Affiliation |
Dr. M.L. Dhawale Memorial Homoeopathic Institute |
| Address |
Department of Practice of Medicine, 2nd floor, Dr.M.L.Dhawale Memorial Homoeopathic Institute, Opposite ST Workshop, Boisar Road, Palghar
Palghar
MAHARASHTRA
401404
India |
| Phone |
9325116836 |
| Fax |
|
| Email |
dr.shalinisharma2111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt. K B HMC and Shri R P Chordiya Hospital, Chandwad, Nashik, 423101,Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Smt. K B Abad Homoeopathic Medical College |
| Address |
Smt. K B Abad Homoeopathic Medical College, Chandwad, Dist- Nashik, Maharashtra 423101 |
| 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 |
| Dr Shalini Mukhdeo Prasad Sharma |
Smt K B Abad HMC Shri R P Chordiya Hospital |
OPD NO.1 ,General Medicine OPD, Ground floor Smt. K B Abad HMC Shri R P Chordiya Hospital Chandwad 423101
Nashik
MAHARASHTRA |
9325116836
dr.shalinisharma2111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, MLDMHI, Palghar |
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 |
Individualized homoeopathic medicines |
Dose of Individualized homoeopathic medicine would be chosen based on totality of symptoms, on the basis of individual susceptibility, dose and the repetition of the medicine will be decided, can be daily dose, or twice or thrice a day,or weekly dose, route of administration of medicine would be oral route, total duration of medicine would be for 12 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients diagnosed with migraine as per ICHD -3
diagnostic criteria
b. Patients suffering from migraine with and without aura.
c. Patients with migraine in all the sexes
d. Patients with minor ailments will be included in
the study
|
|
| ExclusionCriteria |
| Details |
a.Pregnant women
b. Patients suffering from any major comorbidities.
c. Patients with known Psychiatric illnesses
d. Patients using allopathic medicines or painkillers for migraine pain.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Migraine Specific Quality of life Questionnaire (MSQ) version 2.1 will be used to assess the Quality Of life in Migraine Patients |
At 0 month and 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diagnostic Net tool will be used to assess various biological-psychological and social causative factors which influence the quality of life in migraine patients |
At 0 month and 12 month |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
20/02/2026 |
| 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="3"
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
|
This PhD Study is an uncontrolled experimental clinical trial evaluating role of individualized homoeopathic treatment on quality of life of patients suffering from migraine. The primary purpose of this study is to explore the role of homoeopathic medicine on quality of life in patients of migraine. Migraine is a neurological disorder which can have impact on person’s quality of life and productivity. Thus, it is important to measure disability and health-related quality of life in clinical practice and in clinical trials. So MSQ scale (migraine specific quality of life) will be asked at the beginning and conclusion of treatment. |