| CTRI Number |
CTRI/2025/09/094487 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Homoeopathy in Migraine |
|
Scientific Title of Study
|
Efficacy of Individualised Homoeopathic Medicine versus Lac Defloratum in Centesimal scale for the Management of Migraine - A Single Blind Randomised 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 |
Dr Mehr Singh |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine , Nehru Homoeopathic Medical College and Hospital
B- BLOCK , Defence colony , New Delhi 110024
South
DELHI
110024
India |
| Phone |
9873296196 |
| Fax |
|
| Email |
drmehrsingh2812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Thakkar |
| Designation |
HOD ( Practice of Medicine) |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine , Nehru Homoeopathic Medical College and Hospital
B-BLOCK , Defence colony , New Delhi 110024
South
DELHI
110024
India |
| Phone |
8851006347 |
| Fax |
|
| Email |
rakeshthakkar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mehr Singh |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine , Nehru Homoeopathic Medical College and Hospital
B-BLOCK , Defence colony , New Delhi 110024
South
DELHI
110024
India |
| Phone |
9873296196 |
| Fax |
|
| Email |
drmehrsingh2812@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out Patient Department of Nehru Homoeopathic Medical College and Hospital , B-Block Defence Colony New Delhi 110024 |
|
|
Primary Sponsor
|
| Name |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Nehru Homoeopathic Medical College and Hospital B Block Defence Colony 110024 |
| 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 Mehr Singh |
Nehru Homoeopathic Medical College and Hospital |
Department of Practice of Medicine , Nehru Homoeopathic Medical College and Hospital
B- BLOCK , Defence colony , New Delhi 110024
South
DELHI |
09873296196
drmehrsingh2812@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nehru Homoeopathic Medical College and Hospital Institutional Ethics Committee |
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 |
Individualised homoeopathic medicines will be prescribed based on detailed case taking, symptom totality formation, and repertorization using appropriate repertories. A single remedy will be selected according to homoeopathic principles and administered in the centesimal scale. Potency and repetition will be individualised depending on the patient’s symptom severity, susceptibility. Each dose will consist of 4 medicated globules administered orally, either as a single or repeated dose according to clinical response. Follow-ups will be scheduled every 2 weeks or as per the need of the case. |
| Comparator Agent |
Lac Defloratum |
In the comparator arm, patients will receive Lac Defloratum in a suitable centesimal potency after detailed case taking and examination. The dose will be administered orally, with repetition as required depending on the patient’s susceptibility and severity of symptoms. Follow-ups will also be conducted every 2 weeks or as per the need of the case. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals aged between 20 and 60 years, of various socioeconomic background, shall be considered eligible for inclusion in the study.
2.Participants of all genders will be enrolled in the trial.
3.Those cases fulfilling the International Headache Society, diagnostic criteria for migraine.
4.Patient giving written consent form.
|
|
| ExclusionCriteria |
| Details |
1.Individuals with a diagnosed psychiatric disorder.
2.Pregnant and lactating individuals.
3.Patients diagnosed with any form of malignancy.
4.Individuals who are immunocompromised.
5.Patients requiring emergency medical intervention at the time of recruitment.
6.Individuals with uncontrolled systemic hypertension.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Migraine Disability Assessment (MIDAS) questionnaire |
At Baseline and after 4 months of Treatment |
|
|
Secondary Outcome
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2025 |
| 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="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
|
Migraine is a common neurological disorder characterized by recurrent episodes of moderate to severe headache, often accompanied by nausea, vomiting, photophobia, and phonophobia. It significantly impairs quality of life and productivity. Homoeopathy, being a holistic and individualised system of medicine, offers a non-invasive approach aimed at reducing both the intensity and frequency of migraine episodes.
This single-blind randomized controlled trial will be conducted at Nehru Homoeopathic Medical College and Hospital, New Delhi, to evaluate the comparative efficacy of Individualised homoeopathic medicines versus Lac Defloratum in migraine management. Sixty participants between 20–60 years of age, fulfilling the International Headache Society (ICHD-3) diagnostic criteria, will be recruited through purposive sampling. After informed consent, participants will be randomly allocated into two arms (30 each):
Experimental arm: Individualised homoeopathic medicines prescribed on the basis of case taking, repertorisation, and totality of symptoms.
Comparator arm: Lac Defloratum prescribed in suitable potency according to case requirement.
Medicines will be administered orally in centesimal potencies. Potency and repetition will be individualised based on susceptibility, severity, and clinical response. Follow-ups will be conducted every 2 weeks or depending upon the need of the case. The primary outcome is to compare the efficacy of individualized homoeopathic medicine and Lac Defloratum in reducing migraine frequency, intensity, and duration. The secondary outcome is to assess improvement in quality of life using the Migraine Disability Assessment Scale (MIDAS) before and after treatment.
All data will be collected using standardized case proformas, and confidentiality will be maintained. Pharmacovigilance will be ensured, with any adverse events documented and managed appropriately. Statistical analysis will be applied to evaluate outcomes. This study aims to generate reliable comparative data on individualised homoeopathic medicines versus Lac Defloratum, thereby addressing existing research gaps and contributing to evidence-based homoeopathic management of migraine.
|