| CTRI Number |
CTRI/2026/03/105503 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic Treatment for Chronic Migraine Related to Digital Screen Exposure. |
|
Scientific Title of Study
|
Evaluating the Efficacy of Individualized Homeopathic Treatment in Chronic Migraine Associated with Digital Screen Exposure : A Double-Blind, Randomized, Placebo-Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1336-2138 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEHA HAITE |
| Designation |
UnderGraduate Student (B.H.M.S) |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, OPD NO. 17 and 21 The Calcutta Homoeopathic Medical College and Hospital
265-266, Acharya Prafulla Chandra road, Kolkata-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
7044906632 |
| Fax |
|
| Email |
haiteneha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RUPALI BHADURI |
| Designation |
Associate Professor and HOD, Department of Practice of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
The Calcutta Homoeopathic Medical College and Hospital,
Department of Practice of Medicine, OPD N0. 17
265-266, Acharya Prafulla Chandra Road, Kolkata-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9571806989 |
| Fax |
|
| Email |
drrupalibhaduri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RUPALI BHADURI |
| Designation |
Associate Professor and HOD, Department of Practice of Medicine |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
The Calcutta Homoeopathic Medical College and Hospital,
Department of Practice of Medicine, OPD N0. 17
265-266, Acharya Prafulla Chandra Road, Kolkata-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9571806989 |
| Fax |
|
| Email |
drrupalibhaduri@gmail.com |
|
|
Source of Monetary or Material Support
|
| THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265-266, Acharya Prafulla Chandra Road, Kolkata-700009 |
| Type of Sponsor |
Government 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 RUPALI BHADURI |
The Calcutta Homoeopathic Medical College and Hospital |
Department of Practice of Medicine, OPD NO. 17 and 21,
265-266, Acharya Prafulla Chandra Road, Kolkata-700009
Kolkata
WEST BENGAL |
9571806989
drrupalibhaduri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of The Calcutta Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G437||Chronic migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical looking Placebo |
Placebo: A placebo that is identical in appearance and dosage regimen to the individualized remedy, along with general managements.
Dosing: Same regimen as the verum arm for 12 weeks.
Follow-up: Weekly follow-up calls will be conducted to monitor the patient’s progress, adherence to the treatment and to track any side effects.
Dosing: The remedy will be administered as per need of the case for 12 weeks.
Duration of Study:12 weeks. |
| Intervention |
Individualised Homoeopathic Intervention
|
Individualized constitutional Homoeopathic Medicines will be given after proper case taking including the patient’s physical, emotional, and mental symptoms after repertorization with consultation to standard Homoeopathic Materia Medica along with general management.
Follow-up: Weekly follow-up calls will be conducted to monitor the patient’s progress, adherence to the treatment and to track any side effects.
Dosing: The remedy will be administered as per need of the case for 12 weeks.
Duration of Study:12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Adults aged 18-65 years individuals who report using digital screens (computers, phones, or tablets) for a minimum of 4-6 hours per day, on average, for at least 3 months prior to enrolment.
2. Diagnosed with chronic migraine (more than 15 days per month for at least 3 months).
3. Migraine attacks that are moderate or severe (pain intensity greater than 4 on the Visual Analog Scale).
4. Ability to comply with study procedures and attend follow-up visits.
5. Informed consent provided. |
|
| ExclusionCriteria |
| Details |
1.Other types of primary headache disorders (e.g., tension headaches, cluster headaches).
2.Severe systemic diseases (e.g., uncontrolled diabetes, hypertension).
3.Previous treatment with homoeopathic remedies in the last 6 months.
4.History of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder).
5.Pregnancy or lactation.
6.Use of abortive or preventive migraine treatments within 1 week of starting the trial.
7.Participation in other clinical trials or use of experimental treatments. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Migraine Days: The number of days during which the patient experiences a migraine within the 28 days period (or 4 weeks). This will be assessed weekly using patient diaries.
|
Baseline from week 0 to week 12 will be the primary endpoint.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Migraine Disability Assessment (MIDAS)-The change in MIDAS score will be used to measure the impact of treatment on functional disability due to migraines. |
Baseline at 4 weeks, 8 weeks,12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="0"
Months="6"
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
|
Migraine is a common and disabling disorder affecting over 1 billion people worldwide and ranks as the second leading cause of disability in the Global Burden of Disease Study. Chronic migraine severely impacts quality of life and productivity, with digital screen exposure emerging as a trigger. Conventional treatments often have side effects and limited long-term compliance. Individualized homoeopathic treatment has shown promising results in reducing migraine frequency and severity, offering a potential complementary approach. |