| CTRI Number |
CTRI/2024/04/064972 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
A study on Efficacy of individualized Homoeopathic medicines vs conventional medicine in treatment of Chronic Migraine |
|
Scientific Title of Study
|
A randomised comparative study to evaluate the efficacy of individualized Homoeopathic medicines vs conventional medicine in treatment of Chronic 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 |
Divya Verma |
| Designation |
Research Officer |
| Affiliation |
Central Research Institute (Homoeopathy) Lucknow |
| Address |
Researcher area, second floor, Central Research Institute (Homoeopathy), sector-2, Jankipuram extension, Lucknow
Lucknow
UTTAR PRADESH
226031
India |
| Phone |
9871332597 |
| Fax |
|
| Email |
vdivya1526@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Verma |
| Designation |
Research Officer |
| Affiliation |
Central Research Institute (Homoeopathy) Lucknow |
| Address |
Researcher area, second floor, Central Research Institute (Homoeopathy), sector-2, Jankipuram extension, Lucknow
Lucknow
UTTAR PRADESH
226031
India |
| Phone |
9871332597 |
| Fax |
|
| Email |
vdivya1526@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Verma |
| Designation |
Research Officer |
| Affiliation |
Central Research Institute (Homoeopathy) Lucknow |
| Address |
Researcher area, second floor, Central Research Institute (Homoeopathy), sector-2, Jankipuram extension, Lucknow
Lucknow
UTTAR PRADESH
226031
India |
| Phone |
9871332597 |
| Fax |
|
| Email |
vdivya1526@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65, Institutional area, Opposite D- Block, Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
CCRH |
| Address |
61-65, Institutional Area, Opp. D Block, JanakPuri, New Delhi – 110058, India. |
| Type of Sponsor |
Research institution |
|
|
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 |
| Divya Verma |
Central Research Institute (Homoeopathy) |
Doctors Room no 3, second floor, researcher area, CRI(H), sector-2, Jankipuram extension.
Lucknow
UTTAR PRADESH |
9871332597
vdivya1526@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Central Research Institute (Homoeopathy), Lucknow |
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 |
Conventional medicine |
Conventional medicine will be administered for acute attack of migraine in the patients as and when required on the advise of specialized allopathic physician. Dose will be as per the need of the case. In this group Placebo will be given in case there is no acute attack. Route of administration will be oral. Total duration of intervention will be 6 months. |
| Intervention |
Homoeopathic medicine |
Homoeopathic medicine will be given in Centesimal or LM potency. Dose and potency will be given as per the need of the case. Route of administration is oral. Total duration of intervention will be 6 months. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age group between 15- 50 years.
2.Patients of both genders and all religion.
3.Patients willing to provide written informed consent.
4.Patients who is willing to complete all the scheduled study visits.
5.Patient falling in Grade I and II of MIDAS score.
6.Patients having chronic migraine fulfilling the criteria of ICHD-3 for Chronic migraine(The International Classification of Headache Disorders 3rd edition).
|
|
| ExclusionCriteria |
| Details |
1.Any headache other than migraine (i.e. those not meeting ICHD-3 criteria).
2.Patients unwilling to participate in the study.
3.Patient who are pregnant or lactating mother.
4.Patients with other co-morbidities such as uncontrolled diabetes and/or hypertension, thyroid disorders, autoimmune diseases, end stage kidney disease or end stage liver disease or any malignancy etc.
5.Patient undergoing any form of treatment for chronic disease within last 15 days.
6.Patient falling in grades III and IV of MIDAS score.
7.Patients with any infarction or seizure or any other cerebral condition associated with migraine.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Average Number of Migraine attack/month |
baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Migraine attack intensity |
Baseline and 6 months |
| Disability due to migraine |
baseline, 3 months, 6 months |
| Number of Pain killers taken |
baseline and 6 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 2 |
|
Date of First Enrollment (India)
|
16/04/2024 |
| 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
|
This study is a comparative study to see the efficacy of individualized Homoeopathic medicine in treatment of Migraine against conventional medicine. As we all know Migraine is one of the most common disease from which patients are suffering globally and it requires attention of medical science to treat it efficiently. The purpose of this study is to treat Migraine with the help of Individualized Homoeopathic medicines and develop an evidenced based research in treatment of migraine by reducing its attack frequency, duration, intensity and disability caused due to migraine. |