| CTRI Number |
CTRI/2025/02/080237 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic Management of Chronic Migraine in Adolescent Girls |
|
Scientific Title of Study
|
A Clinical Study On The Homoeopathic Management Of Chronic Migraine in Adolescent Girls |
| 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 Gokul S |
| Designation |
PG Scholar |
| Affiliation |
White Memorial Homoeo Medical College Hospital |
| Address |
Department of Paediatrics White Memorial Homoeo Medical College and Hospital Chevarcode Attoor Veeyanoor Kanniyakumari District
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9345637616 |
| Fax |
|
| Email |
gokulsuresh.ntp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T K NAGENDRAN |
| Designation |
Professor and Head Of the Department |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Paediatrics White Memorial Homoeo Medical College and Hospital Chevarcode Attoor Veeyanoor Kanniyakumari District
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9345637616 |
| Fax |
|
| Email |
drtkn1996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gokul S |
| Designation |
PG SCHOLAR |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Paediatrics White Memorial Homoeo Medical College and Hospital Chevarcode Attoor Veeyanoor Kanniyakumari District
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9345637616 |
| Fax |
|
| Email |
gokulsuresh.ntp@gmail.com |
|
|
Source of Monetary or Material Support
|
| White Memorial Homoeo Medical College and Hospital Chevarcode Attoor Kanniyakumari 629177 |
|
|
Primary Sponsor
|
| Name |
White Memorial Homoeo Medical College and Hospital |
| Address |
White Memorial Homoeo Medical College and Hospital Chevarcode Attoor Veeyanoor Kanniyakumari District 629177 |
| 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 Gokul S |
White Memorial Homoeo Medical College and Hospital |
White Memorial Homoeo Medical College and Hospital
OPD IPD of Department of Paediatrics, Peripheral centres and School camp Chevarcode Attoor Veeyanoor Kanniyakumari 629177
Kanniyakumari
TAMIL NADU |
9345637616
gokulsuresh.ntp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G437||Chronic migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
homoeopathic similimum |
dose once in 15 days
placebo daily dose |
| Comparator Agent |
nil |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Female |
| Details |
children of age group twelve to eighteen years are included
adolescent female who already diagnosed with chronic migraine are graded using migraine disability assessment scale
patient with complaints of migraine more than three months included |
|
| ExclusionCriteria |
| Details |
patient whose midas score above twenty is excluded
patients who had history of any psychological disorders
patients associated with any other systemic disorders
patients who are taking other pain relief medication are excluded
patients suffering from other disease such as sle renal failure diabetes mellitus secondary hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pre and post assessment of change in MIDAS score in adolescent girls |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in clinical symptoms |
1 year |
|
|
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 4 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - all the data will be provided through email gokulsuresh.ntp@gmail.com
- For how long will this data be available start date provided 08-03-2027 and end date provided 08-03-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
A CLINICAL STUDY ON THE HOMOEOPATHIC MANGEMENT OF CHRONIC MIGRAINE IN ADOLESCENT GIRLS Migraine is a neurological disorder that affects million of children and adolescent world wide chronic migraine is subtype of migraine in which patient experience headache for more days that not each month with accompanying symptoms of phonophobia photophobia nausea or vomiting children of age group 12 to 18 years included a sample total of 60 cases satisfying the inclusion and exclusion criteria will be taken for the study patient with complaints of migraine more than 3 months are included midas questionnaire used as tool for intervention cases will be taken in detail and recorded in the standardized case record of white memorial homoeo medical college and hospital prescription will be selected based on the totality of particular case potency selection repetition will adhere to the principles outlined in the organon of medicine pre and post treatment analysis will be done using midas questionnaire score |