| CTRI Number |
CTRI/2025/03/082213 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate the Effectiveness of the Homeopathic Remedy Prunus Spinosa in Migraine Patients Using the MIDAS Tool |
|
Scientific Title of Study
|
An Interventional Study To Assess The Effectiveness Of
Prunus Spinosa 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 Suraj Bhan Singh Rathore |
| Designation |
PG Student |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia Medica
Dr MPK Homoeopathic Medical College Hospital and Research Centre A constituent college of Homoeopathy
Jaipur
RAJASTHAN
302029
India |
| Phone |
09511583462 |
| Fax |
|
| Email |
Suryabhansinghrathore411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Tuteja |
| Designation |
Professor |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia Medica
Dr MPK Homoeopathic Medical College Hospital and Research Centre A constituent college of Homoeopathy
Jaipur
RAJASTHAN
302029
India |
| Phone |
9530454132 |
| Fax |
|
| Email |
drsoniatuteja@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suraj Bhan Singh Rathore |
| Designation |
PG Student |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia Medica
Dr MPK Homoeopathic Medical College Hospital and Research Centre A constituent college of Homoeopathy
Jaipur
RAJASTHAN
302029
India |
| Phone |
09511583462 |
| Fax |
|
| Email |
Suryabhansinghrathore411@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Materia Medica Dr Girendra Pal Homoeopathic Hospital And Research Centre Collegiate Hospital Of Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Dr MPK Homoeopathic Medical college hospital and research Cetre 10 11 12 Ward no 36 Saipura Sanganer Jaipur Rajasthan 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 Suraj Bhan Singh Rathore |
Dr Girendra Pal Homoeopathic Hospital And Research Centre |
Department of Materia Medica Dr MPK Homoeopathic Medical College Plot no 10 11 12 ward no 36 saipura sanganer
Hospital and Research Centre A constituent college of Homoeopathy
University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN |
09511583462
Suryabhansinghrathore411@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: G437||Chronic migraine without aura, (2) ICD-10 Condition: G431||Migraine with aura, (3) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Prunus Spinosa |
All the eligible patients having the symptoms of Headache will be prescribed Homoeopathic medicine Prunus spinosa. Homoeopathic Medicine shall be given orally in any Potency as per the susceptibility of the patient and the Hahnemannian Guidelines of Organon of Medicine in the form of Globules of 40 number. Dose and repetition as per the need for the case. The reassessment would be done with a minimum of six visits or observations and an interval of 15
& 7 days can be obtained from the last case. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who give consent to study
Previously diagnosed cases of headache, and the patient is ready to stop all other medical
treatment
Patient suffering from signs and symptoms suggestive of headache irrespective of
diagnosis |
|
| ExclusionCriteria |
| Details |
Cases that required emergency treatment
Patients pursuing other treatments and were not willing to leave it
Pregnant women and lactating mothers will not be included in the study
Immune
compromised patients such as those suffering from HIV, Hepatitis B and C, etc
Cases with multi systemic illness will be excluded from the study and cases with advance
pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement obtained from treatment (Pre and Post) using MIDAS tool |
Pre scores will be taken at the baseline of the treatment and post scores will be assessed at the end of 12 weeks using Migraine Disability assessment test(MIDAS) Tool |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effectiveness of Homoeopathic medicine Prunus spinosa in cases of
Migraine.
To assess the effectiveness of Homoeopathic medicine Prunus
Spinosa in cases of Migraine
using NRS score |
12 months |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/03/2025 |
| 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 Yet Recruiting |
| 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
|
Aim: To assess the effectiveness of Homoeopathic medicine Prunus spinosa in cases of
Migraine using the MIDAS tool. Objectives: 1. To assess the effectiveness of Homoeopathic medicine Prunus spinosa in cases of Migraine
using the MIDAS tool. 2.
To assess the effectiveness of Homoeopathic medicine
Prunus
spinosa in cases of Migraine
using NRS score.
Null Hypothesis (H0) – There is no significant improvement in cases of Migraine treated with
homoeopathic medicine Prunus spinosa.
Alternate Hypothesis (H1) –There is a significant improvement in cases of Migraine treated with
homoeopathic medicine Prunus spinosa. |