| CTRI Number |
CTRI/2023/05/052590 [Registered on: 12/05/2023] Trial Registered Prospectively |
| Last Modified On: |
12/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Migraine treatment in homoeopathy |
|
Scientific Title of Study
|
"A prospective randomised double arm parallel Clinical study "
To compare the effectiveness of constitutional versus therapeutic remedies in the management of migraine. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Sharma |
| Designation |
Junior Resident doctor |
| Affiliation |
NHMC DELHI |
| Address |
Nehru homoeopathic medical College and hospital defence colony block b New Delhi
South
DELHI
110024
India |
| Phone |
7982808632 |
| Fax |
|
| Email |
priya96cbg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bipin jethani |
| Designation |
Professor at NHMC DELHI |
| Affiliation |
NHMC University of Delhi |
| Address |
A-9 Lajpat Nagar -2 New Delhi
South
DELHI
110024
India |
| Phone |
9810146343 |
| Fax |
|
| Email |
drbipin.jethani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Sharma |
| Designation |
Junior Resident doctor |
| Affiliation |
NHMC DELHI |
| Address |
Nehru homoeopathic medical College and hospital defence colony block b New Delhi
South
DELHI
110024
India |
| Phone |
7982808632 |
| Fax |
|
| Email |
priya96cbg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out patients and in patients department of Nehru homoeopathic medical College and hospital defence colony block b New Delhi |
|
|
Primary Sponsor
|
| Name |
Priyanka Sharma |
| Address |
Nehru homoeopathic medical College and hospital defence colony block b New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Priyanka Sharma |
Nehru homoeopathic medical College and hospital defence colony block b |
Nehru homoeopathic medical College and hospital defence colony block b New Delhi
South
DELHI |
7982808632
priya96cbg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of individualized homoeopathic medicine |
After obtaining consent and
asked all questions in case
performa medicine precribed
according to indivisualization,.dose- 4-5 globules will be given orally and repetition and frequency will depend upon susceptibility of the patients.
along with proper diet as well as
General Management. all
medicines procured from Good
Manufacturing Practice. (GMP) |
| Comparator Agent |
Therapeutic homeopathic medicines |
After obtaining consent and
asked all questions in case
performa medicine precribed
according to the disease condition most suitable therapeutic homeopathic medicine will be given.
Medicine taken on Oral route,
Dose4-5 globules of selected therapeutic medicine and Repetition and frequency depends
upon susceptibility of the patients
along with proper diet as well as
General Management. all
medicines procured from Good
Manufacturing Practice. (GMP) |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Have a history of migraine as defined by the International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2006) of at least 1 year prior to enrollment, migraine onset prior to age 50, and a moderate frequency of migraine headaches
Have clinical laboratory test results within normal reference ranges or, if outside the normal range, judged not clinically significant by the Investigator
Must not be on any migraine prevention therapy, including botulinum toxin (Botox)
Agree not to post any personal medical data related to the study or information related to the study on any website or social media site (for example, Facebook, Twitter, et cetera) until the trial has completed. |
|
| ExclusionCriteria |
| Details |
Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device, or concurrent enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study.
History of chronic migraine or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine
History of headache (for example, cluster headache or Medication Overuse Headache [MOH]) other than migraine or tension type headache as defined by IHS ICHD-II within 12 months prior to randomization
Evidence of significant active psychiatric disease including, but not limited to, manic depressive illness, schizophrenia, generalized anxiety disorder, obsessive compulsive disorder, personality disorders, or other serious mood, anxiety, depression, or substance use disorders
Women who are pregnant or nursing
Excessive alcohol, opiate, or barbiturate use; history of drug abuse or dependence
Patients who are terminally ill, under immunosuppressive treatment or self-reported immunocompromised state.
Unwilling to take part and not giving consent to join the study or unable to read patient information sheet.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done using MIDAS SCALE |
One at the baseline and other at the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depending upon the severity of the symptoms and as per the need and necessity of the case |
Every 2 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/05/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
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 prospective randomised double arm parallel Clinical study" To compare the effectiveness of constitutional versus therapeutic homeopathic remedies in the management of migraine. Research question is - is there any significant difference between the two comparable groups ie. constitutional remedies and therapeutic remedies in the management of migraine. Objectives are to assess the treatment outcome by using MIDAS scale. Study duration is one year, 60 patients are included in the study, patients are followed every month upto 1 year. Outcome will be measured one at baseline and other at the end of the study. |