| CTRI Number |
CTRI/2024/12/078315 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of Headache in adults |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial of individualized homeopathic medicines to treat migraine in adults utilizing Boenninghausen’s hexameter for using Boenninghausen’s Characteristics and Repertory by C.M. Boger |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1315-9205 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Sen |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Repertory, OPD room no. PG3, PG5 and 7 (ENT), 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
08259024415 |
| Fax |
|
| Email |
priyankasen072@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajat Kumar Pal |
| Designation |
Professor and Head |
| Affiliation |
D n De Homoeopathic Medical College and Hospital |
| Address |
Dept of Repertory, OPD room no. PG3, PG5 and 7 (ENT), 12, Gobinda Khatick Road
12 Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
09433130996 |
| Fax |
|
| Email |
drrajatkumarpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Kumar Pal |
| Designation |
Professor and Head |
| Affiliation |
D n De Homoeopathic Medical College and Hospital |
| Address |
Dept of Repertory, OPD room no. PG3, PG5 and 7 (ENT), 12, Gobinda Khatick Road
12 Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
09433130996 |
| Fax |
|
| Email |
drrajatkumarpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital 12 Gobinda Khatick road Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khatick road Kolkata 700046 |
| 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 Priyanka Sen |
D N De Homoeopathic Medical College and Hospital |
Dept of Repertory OPD no PG 3 and Medicine OPD no PG 5 and ENT OPD no 7, 12, Gobinda Khatick Road, Kolkata 700046
Kolkata
WEST BENGAL |
8259024415
priyankasen072@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D. N. De 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 |
| Comparator Agent |
Identical-looking placebo and concomitant care |
A placebo that looks identical to the verum will be administered to this arm. Each dose of placebo will consist of 4 cane sugar globules (no. 40), moistened with rectified spirit, to be consumed orally on clean tongue and in empty stomach; dosage 11
and repetition
will be given depending upon the individual case requirement. Similar to the experimental arm, management directions will be provided. Concomitant care measures include lifestyle changes, yoga, dietary management. Route of administration: per oral. Duration of therapy: 3 months. |
| Intervention |
Individualized homoeopathic medicines in individualized dosage and concomitant care |
The enrolled patients of migraine will be treated with IHMs selected using Boenninghausen’s hexameter while using BCR to determine the most appropriate remedy. The indicated homoeopathic medication will be administered in centesimal potencies as part of the proposed intervention, as decided appropriate to the case or condition. Each dose, measured in centesimal scale, must contain 4 cane sugar globules (no. 40) medicated with the indicated drug (kept in 90% v/v ethanol) to be consumed orally on clean tongue and in empty stomach; dosage and repetition will be given depending upon the individual case requirement. It will be advised to patients not to handle the globules and not to consume any food, liquids, smoke or brush their teeth within 30 minutes of taking the globules and will be asked to suck the globules instead of simply swallowing them. Every time, a single, individualized medication will be prescribed taking into account presenting totality of symptom, clinical history details, constitutional features, miasmatic expressions, repertorization using BCR with the aid of HOMPATH software in each case with due consultation of Materia Medica and due consensus among three homoeopaths. A firm accredited by Good Manufacturing Practices (GMP) will supply all medications and other items. Based on the principles of classical homoeopathy, provisions will be made for changing the medications or potencies and alter the dosage in subsequent visits as needed and such instances will be compared between groups. Concomitant care measures include lifestyle changes, yoga, dietary management. Route of administration: per oral. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 18-50 years.
2. Either sex or transgender.
3. Patients having migraine (ICD 10 code G43) as per the criteria of International Classification of Headache Disorders (ICHD-3) for migraine.
I. Migraine with aura
a. Headache attacks lasting 4 to 72 hours (untreated or unsuccessfully treated)
b. Headache has at least 2 of the following characteristics:
i. Unilateral location
ii. Pulsating quality
iii. Moderate-to-severe pain intensity
iv. Aggravation by or causing avoidance of routine physical activity (walking or climbing stairs)
c. During a headache, at least 1 of the following:
i. Nausea and/or vomiting
ii. Photophobia and phonophobia
II. Migraine with aura
a. 1 or more of the fully reversible aura symptoms mentioned below:
i. Visual
ii. Sensory
iii. Speech and language
iv. Motor
v. Brainstem
vi. Retinal
b. At least 2 of the characteristics mentioned below:
i. At least 1 aura symptom spreads gradually over 5 or more minutes
ii. 2 or more aura symptoms occur in succession
iii. Each aura symptom lasts 5 to 60 minutes
iv. At least 1 aura symptom is unilateral
v. At least 1 aura symptom is positive
vi. The aura is accompanied, or followed within 60 minutes, by the headache
III. On 8 days or more per month for more than 3 months, fulfilling any of the below mentioned criteria: 9
a. Criteria Ib and Ic: For migraine without aura
b. Criteria IIa and IIb: For migraine with aura
c. Believed by the patient to be migraine headaches at onset and relieved by triptan or ergot derivative
4. Patients with ability to understand English/ Hindi/ Bengali. |
|
| ExclusionCriteria |
| Details |
1. Denying informed consent.
2. Patient suffering from little or no disability (MIDAS Score less than or equal to 20) and severe disability (MIDAS Score more than or equal to 20) from migraine.
3. An acute, severe headache, particularly if it is the first or worst episode and there has been a noticeable shift in the frequency or pattern of headaches.
4. Abnormal neurologic examination, particularly in cases when there are unidentified indications or symptoms (e.g., stiff neck, confusion, papilledema, epilepsy).
5. New episodes in immunocompromised or elderly patients (more than 50 years of age)..
6. Signs or symptoms that are meningeal or systemic e.g. fever, weight loss, exhaustion.
7. Pain that lasts longer than 72 hours.
8. Pregnancy, nursing mothers, and puerperal women.
9. Chewing tobacco, smoking, alcoholism, substance misuse in any form, and/or dependence (TAPS tool).
10. Receiving homoeopathic treatment for a chronic illness all through the previous three months.
11. Simultaneously taking part in any other clinical trial. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Migraine Disability Assessment questionnaire (MIDAS) |
Baseline and after 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 36-Item Short Form Health Survey questionnaire (SF-36) |
Baseline and every month up to 3 months |
| Measures Yourself Medical Outcome Profile version 2 questionnaire (MYMOP-2) |
Baseline and every month up to 3 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="99"
Sample Size from India="99"
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)
|
01/01/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [priyankasen072@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Migraine episodes last 4-72 hours, often with moderate to severe one-sided, pulsating headaches, worsened by physical activity, and accompanied by phonophobia, photophobia, nausea, or vomiting. Global migraine prevalence has risen significantly over the past three decades, from 721.9 million in 1990 to 1.1 billion in 2019, and is now the second leading cause of neurological disability-adjusted life-years. Homeopathy is frequently used therapy to treat migraine , however the research evidence is limited. . The systematic approach to analysis, evaluation, and totality framing using Boenninghausen’s Characteristics and Repertory (BCR) is not clearly outlined in the available literature. Within the chapter choosing the remedy, Dr Boger “shows how the final differentiation depends upon the individualistic or peculiar symptoms. A truly scientific procedureâ€. He outlines seven key points for remedy selection, which are also explained in Boenninghausen’s Lesser Writings under the hexameter. In this study, these hexameter points will consistently be used to frame totality during repertorization for all cases treated with BCR. This 3 months, double-blind, randomized, placebo-controlled is aimed at evaluating the efficacy of homeopathic medicines in the treatment of migraine in 99 adults. The primary outcome measure is MIDAS, measured at baseline and after 3rd month; the secondary outcomes are SF-36, MYMOP-2 questionnaires, all measured at baseline, and every month, up to 3 months. Comparative analysis will be measured to detect group differences. Results will be published in scientific journals. |