| CTRI Number |
CTRI/2025/12/099762 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of migraine in women |
|
Scientific Title of Study
|
Effectiveness of Individualised Homoeopathic Medicines in the Management of Migraine Among Women and Improvement of Quality of Life using Kent's Repertory: A Pre-Post Interventional 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 Nishat Parveen |
| Designation |
Post graduate Trainee( Department of Homoeopathic Repertory and Case Taking) |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Repertory and Case Taking, 1st Floor, Mahesh Bhattacharyya Homoeopathic Medical College and Hopsital,Sailen Manna Sarani,Dumurjola, Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
8001282882 |
| Fax |
|
| Email |
nishatparveen185@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purnendu Ash |
| Designation |
Reader, Department of Homoeopathic Repertory and Case Taking |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Repertory and Case Taking, 1st Floor, Mahesh Bhattacharyya Homoeopathic Medical College and Hopsital,Sailen Manna Sarani,Dumurjola, Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
9051420436 |
| Fax |
|
| Email |
purnendubhms29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purnendu Ash |
| Designation |
Reader, Department of Homoeopathic Repertory and Case Taking |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Department of Homoeopathic Repertory and Case Taking, 1st Floor, Mahesh Bhattacharyya Homoeopathic Medical College and Hopsital,Sailen Manna Sarani,Dumurjola, Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
9051420436 |
| Fax |
|
| Email |
purnendubhms29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Sailen Manna Sarani, Dumurjola, Howrah-711104 |
| 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 Nishat Parveen |
Mahesh Bhattacharyya Homoeopathic College and Hospital |
Deoartment of Homoeopathic Repertory and Case Taking,OPD Room no. 1,2,3,4,5,9,11 of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital,Sailen Manna Sarani, Dumurjola, Howrah-711104
Haora
WEST BENGAL |
8001282882
nishatparveen185@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
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 |
Individualised Homoeopathic Medicine |
This intervention is planned for administering indicated Homoeopathic medicine in centesimal and 50-millesimal potencies, appropriate to the case to be taken orally on clean tongue in empty stomach. Doses and repetition depending upon the individual. For centesimal scale, each dose shall consist of 4-5 globules(no.20) of cane sugar medicated with the indicated homoeopathic medicine(preserved in 90% v/v ethanol). For 50- millesimal potency, the indicated medicine will be dispensed with 1 globules no. 10 in 100 ml of distilled water, with a 5 drops of rectified spirit. The vial will be marked with 14 doses. The doses and repetition shall depend upon the individual requirement of the patient. The patients will be adviced to refrain from handling the globules or from eating, drinking, smoking or brushing the teeth within 1 hour of taking the medicine. The medicines will be procured from a good manufacturing practice (GMP) certified firm. The follow up for intervention group will be continued for every month till six months for each case. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Self reporting patients suffering at least five attacks of migraine lasting for four to seventy two hours.
Female patients of reproductive age group fifteen to forty nine years.
Patients who are not under any homoeopathic treatment for last four weeks.
Patients willing to give written informed consent to participate in the trial. |
|
| ExclusionCriteria |
| Details |
Patients having any substance abuse like caffeine or alcohol as they act as triggering factors.
Pregnancy and lactating mother.
Person using OCP regularly as it may induce migraine itself.
Patients using any other medicine for migraine for past two weeks.
Patients pursuing treatment for any major systemic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effectiveness of individualized homoeopathic
medicines in reducing the severity of pain in the patients suffering from
migraine using the Visual Analogue Scale for Pain. |
The score will be assessed at the baseline and after 6 months of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the improvement in overall Quality of Life using Migraine
Specific Quality of Life Questionnaire (MSQ) Version 2.1 |
The score will be assessed at the baseline and after 6 months of treatment. |
To determine the most frequently indicated homoeopathic medicines and
their indication in the treatment of migraine. |
At the end of the study. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/12/2025 |
| 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
|
The study titled “Effectiveness of Individualized Homoeopathic
Medicines in the Management of Migraine Among Women and Improvement of Quality
of Life Using Kent’s Repertory: A Pre-Post Interventional Study”. The research
aims to evaluate the effectiveness of individualized homeopathic medicines in
managing migraine and improving the quality of life in women among 15-49 years
age group. The primary objective of the study is to determine the effectiveness
of individualized homeopathic medicines in migraine using the Visual Analogue Scale
(VAS) for pain assessment at the baseline and after six months of treatment.
The secondary objective is to assess the improvement in Quality of Life using
the Migraine Specific Quality of Life Questionnaire (MSQ) version 2.1 to be
assessed at the baseline and after six months of treatment. Another secondary objective
is to determine the frequently used homoeopathic medicines in the treatment of
migraine, to be established after six months of treatment. The study follows a
prospective pre-post intervention design with a total of 40 participants. The
study maintains strict adherence to ethical principles, with prior approval
obtained from the Institutional Ethics Committee (IEC) of the college.
Participants’ confidentiality, informed consent, and freedom to withdraw from
the study at any stage are ensured throughout. Overall, this research endeavors
to provide an evidence-based evaluation of the role of individualized
homoeopathic treatment in improving the quality of life and reducing pain in
patients with migraine. |