| CTRI Number |
CTRI/2024/02/063160 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding How Homeopathic Medicine Can Help Ease Migraine Headaches: Using a Special Approach to Improve Quality of Life |
|
Scientific Title of Study
|
Efficacy of Homoeopathic medicine in the management of Migraine without aura using Boger Boenninghausen characteristic repertory with assessing the quality of life |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ISAAC KIRUBAGARAN A |
| Designation |
Post Graduate Scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College And Hospital |
| Address |
Department of Repertory OPD Room No 3C Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main
Road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
7358018716 |
| Fax |
|
| Email |
isaackirubagaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Esther DevaRamya |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory OPD Room No 3C Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main
Road Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
09865191996 |
| Fax |
|
| Email |
estherdevaramya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Esther DevaRamya |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory OPD Room No 3C Vinayaka Missions
Homoeopathic Medical College and Hospital NH 47 Sankari Main
Road Seeragapadi
TAMIL NADU
636308
India |
| Phone |
09865191996 |
| Fax |
|
| Email |
estherdevaramya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road
Seeragapadi PO Salem TAMILNADU 636308 India |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
NH 47 Sankari Main Road Seeragapadi PO Salem TAMIL NADU
636308 India |
| 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 |
| ISAAC KIRUBAGARAN A |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room No 3C-1 PG
Department of
Repertory OPD Medical
Unit III Ground Floor
Hospital Block
Vinayaka Missions
Homoeopathic Medical
College and Hospital
NH 47 Sankari Main
Road Seeragapadi PO
Salem TAMIL NADU
636308 INDIA
Salem
TAMIL NADU |
7358018716
isaackirubagaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Vinayaka Missions Kirupananda Variyar Medical College And Hospital Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Remedy |
Homoeopathic medicines are selected based on the individualization of the patient.
Based on the susceptibility of the patient the doses are selected.
Medicine is administered via the oral route.
Follow-up is taken once every 30 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
All cases that fit into the IHS CLASSIFICATION ICHD- 3 diagnostic criteria, The patients of age 13 to 40, Patients of both sexes are included. |
|
| ExclusionCriteria |
| Details |
Cases that do not fit IHS CLASSIFICATION ICHD – 3
Patients with primary psychiatric disorders (depression, anxiety, psychosis)
Patients with major medical illnesses like renal, hepatic, neurological, and cardiac
diseases, pregnancy, and pure menstrual migraine.
Patients suffering from life-threatening diseases.
Patients who require emergency medical intervention. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
it is expected that the proposed study will be
useful in reducing the recurrence and severity of migraine without aura. |
At baseline and at the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessement of patient with gout is done based
upon the quality of life using Migraine Specific Quality of Life Questionnaire. |
At baseline and at the end of study |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
01/03/2024 |
| 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="3"
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 - NO
|
|
Brief Summary
|
Migraine is characterized by episodic, throbbing hemi cranial headache, beginning in childhood, adolescence or early adult life with a tendency to decrease in intensity and frequency as age advances. Migraine is usually an episodic headache associated with certain features such as sensitivity to light, sound, or movement; nausea and vomiting often accompany the headache. A positive diagnosis can be obtained using symptom-based criteria that include attacks including pain on one side of the head, there would be at least five attacks, each lasting between four and 72 hours and there may be at least one of the following symptoms such as nausea and vomiting or light and sound discomfort. Assessment of the quality of life is aimed at displaying the efficacy of homoeopathic medicine in managing Migraines using the MSQ (Migraine Specific Quality of Life Questionnaire). Homeopathic treatment is based on the totality of symptoms which is obtained after individualizing the case and finding out the cause & characteristics of the person. Since migraine is the most common form of vascular headache and presents with a lot of clinical symptoms, Boger Boenninghausen Characteristic Repertory is selected which fulfills the requirement of ailments from modifying symptoms, concomitants, and clinical symptoms. As the Boger Boenninghausen Characteristic Repertory has maximum rubrics with relation to the symptoms of migraine without aura and to find out the cause of initiation of symptoms, this repertory is taken to complete the study of management of migraine without aura. |