| CTRI Number |
CTRI/2023/06/053801 [Registered on: 13/06/2023] Trial Registered Prospectively |
| Last Modified On: |
11/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Homoeopathy in migraine |
|
Scientific Title of Study
|
A Comparative Study To Assess the Effectiveness of INDIVIDUALIZED HOMOEOPATHIC MEDICINES VIS A VIS PATHOLOGICAL SIMILE in Cases of Migraine using MIDAS TOOL |
| 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 Aayushi Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Dr MPK Homoeopathic Medical College Hospital and Research Centre a constitute College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9450418185 |
| Fax |
|
| Email |
aayushigupta3648@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Singh |
| Designation |
Professor |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Dr MPK Homoeopathic Medical College Hospital and Research Centre a constitute College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
08875320707 |
| Fax |
|
| Email |
dr.ruchisingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aayushi Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy Dr MPK Homoeopathic Medical College Hospital and Research Centre a constitute College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9450418185 |
| Fax |
|
| Email |
aayushigupta3648@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Girendra Pal Homoeopathic Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Saipura Sanganer Jaipur 302029 |
| 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 Aayushi Gupta |
Dr Girendra Pal Homoeopathic Hospital and Research Centre |
Department Of Organon of Medicine and Homoeopathic Philosophy, Room No. 2, Unit 1 Dr MPK Homoeopathic Medical College Hospital and Research Centre, Homoeopathy University, 10, 11, 12, Hahnemann Marg, Diggi Malpura Road, Saipura Sanganer Jaipur Pin Code 302029
Jaipur
RAJASTHAN |
9450418185
aayushigupta3648@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Homoeopathy University Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G43||Migraine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine |
Medicine is selected on the basis of individualized homoeopathic approach |
| Comparator Agent |
Homoeopathic medicine |
Medicine is selected on the basis of pathological simile |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both sexes
2.Patients giving volunatary consent for the study
3.Cases of Migraine diagnosed according to ICHD criteria
|
|
| ExclusionCriteria |
| Details |
1.Cases who refuse to give informed consent for the study
2.Cases with any other severe systemic disorder with advanced pathological conditions
3.Co-morbidities other than migraine
4.Pregnant and lactating women
5.Patients suffering from autoimmune diseases, HIV, etc
6.Patient pursuing other treatment and are not willing to leave it
7.Complications of migraine (according to ICHD)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
According to the scores obtained (pre
and post treatment) from the MIDAS (Migraine Disability Assessment Test) |
Pre scores will be taken at baseline of treatment and
post scores will be assessed at the end of 12 weeks using
MIDAS (Migraine Disability Assessment Test) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the treatment response in cases of Migraine treated with ‘Individualized Homoeopathic medicines selected on basis of Totality of symptoms’ vis a vis ‘Pathological simile selected on basis of specific similarity by Richard Hughes’ using MIDAS tool
|
12 Months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/06/2023 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is prospective, randomized, parallel arm, interventional study to evaluate the role of homoeopathic medicines in cases of migraine.The primary outcome measures will be According to the scores obtained (pre and post treatment) from the (MIDAS) Migraine Disability Assessment Test. The Secondary outcome is to assess the effectiveness of ’Individualized Homoeopathic Medicines’ vis a vis ’Pathological Simile’ in cases of Migraine using (MIDAS)Migraine Disability Assessment test. Null Hypothesis (H0) – There is no significant difference in improvement in cases of Migraine treated with homoeopathic medicines selected on basis of totality of symptoms vis a vis pathological simile selected on basis of Hughes concept of specific similarity AlternateHypothesis (H1) –There is a significant difference in improvement in cases of Migraine treated with homoeopathic medicines selected on basis of totality of symptoms vis a vis pathological simile selected on basis of Hughes concept of specific similarity
|