| CTRI Number |
CTRI/2024/03/064764 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic medicine in the management of Migraine headache. |
|
Scientific Title of Study
|
A clinical study to evaluate the utility of Homoeopathic Medical Repertory by Robin Murphy in the treatment of Common and Classical Migraine. |
| 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 Shilpa Prasad |
| Designation |
Ph.D. Scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Medicine III OPD
Department of Repertory
Vinayaka Missions Homoeopathic Medical College and Hospital
Chinna Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
8281292904 |
| Fax |
|
| Email |
shilpaprasad007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr E. Rathnasabapathy |
| Designation |
Ph.D. Guide |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Medicine III OPD
Department of Repertory
Vinayaka Missions Homoeopathic Medical College and Hospital
Chinna Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9842765594 |
| Fax |
|
| Email |
drersaba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E. Rathnasabapathy |
| Designation |
Ph.D. Guide |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Medicine III OPD
Department of Repertory
Vinayaka Missions Homoeopathic Medical College and Hospital
Chinna Seeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9842765594 |
| Fax |
|
| Email |
drersaba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital, Chinnaseeragapadi, Salem 636308 TAMIL NADU |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Chinnaseeragapadi
Salem 636308
Tamil Nadu |
| 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 |
| Dr Shilpa Prasad |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Medicine III OPD
Department of Repertory
Vinayaka Missions Homoeopathic Medical College and Hospital
Chinnaseeragapadi
Salem
TAMIL NADU |
8281292904
shilpaprasad007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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, (2) ICD-10 Condition: G431||Migraine with aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines (similimum), selected based on Murphys Repertory. |
Homoeopathic remedies are selected from Murphys Repertory based on individualization of the patient. Homoeopathic similimum is administered in centesimal potency. 3 medicated globules of 30 size will be prescribed to the patients three times a day before food via oral route. Follow up is taken once a month. Maximum treatment period per patient is 18 months. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Sample of 95 patients with Common and Classical Migraine, of both sexes with the age group of 18 years to 70 years.
2. Patients suffering from Common and Classical Migraine, screened using Migraine Screen Questionnaire and diagnosed based on International Classification of Headache Disorders-2 (ICHD-2) diagnostic criteria.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Patients with psychiatric complaints
4. Pediatric Cases
3. Patients suffering from headache with other systemic diseases. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of score in MIDAS, HIT-6 and MSQoL questionnaire. |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MIDAS score, MSQoL score, HIT 6 score will be reduced at the end of study period. |
At baseline and at the end of the study |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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 4 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="2"
Months="0"
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 the third most prevalent disease and sixth leading cause of disability world wide. 12% of the population including children suffers from Migraine and most suffers experience Migraine attacks once or twice a month. More than 90% of the sufferers are unable to work or function normally during their Migraine as it affects their day to day life. In its extremely severe form, it poses a great therapeutic challenge to the treating physician.
Homoeopathy plays a great role in the treatment of Migraine. Homoeopathic medicines not only annihilate the disease in its whole extent in the shortest, most reliable and most harmless way, but also prevent the complications associated with it. The treatment of Migraine with Homoeopathic medicines has proved to cure the cases miraculously by treating the root cause of the disease and giving the patient a long term relief from the suffering by treating the vital force at a dynamic level hence preventing the further recurrence of the disease.
The Homoeopathic Medical Repertory by Robin Murphy is a modern alphabetical repertory. A separate chapter on Headache has been added in the second and third edition of this book. The chapter on Headache has very useful rubrics related to Migraine and can be used for systemic Repertorization. All types of cases can be repertorized using this Repertory. |