| CTRI Number |
CTRI/2025/10/095611 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of medicine selected from Repertory of Homoeopathic Materia Medica by Dr. J T Kent for treatment of Migraine |
|
Scientific Title of Study
|
Randomized study on the impact of Homoeopathic Materia Medica by J T Kent based prescribing for the treatment of 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 |
Dr Harshit Kumar |
| Designation |
PG( Scholar) |
| Affiliation |
Sri Ganganagar Homeopathic Medical College Hospital And Research Institute |
| Address |
Repertory department Sri Ganganagar Homeopathic Medical College Hospital And Research Institute
Near RIICO Bus Stand Hanumangarh Rd , Sri Ganganagar, Rajasthan
Ganganagar
RAJASTHAN
335002
India |
| Phone |
7983017630 |
| Fax |
|
| Email |
kumarhomoeopaths@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dushant Trigotra |
| Designation |
Assiciate Professor, guide |
| Affiliation |
Sri Ganganagar Homeopathic Medical College Hospital And Research Institute |
| Address |
Sri Ganganagar Homeopathic Medical College Hospital And Research Institute
Near RIICO Bus Stand Hanumangarh Rd , Sri Ganganagar, Rajasthan
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9876995003 |
| Fax |
|
| Email |
dushant.trigotra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshit Kumar |
| Designation |
PG( Scholar) |
| Affiliation |
Sri Ganganagar Homeopathic Medical College Hospital And Research Institute |
| Address |
Repertory department Sri Ganganagar Homeopathic Medical College Hospital And Research Institute
Near RIICO Bus Stand Hanumangarh Rd , Sri Ganganagar, Rajasthan
Ganganagar
RAJASTHAN
335002
India |
| Phone |
7983017630 |
| Fax |
|
| Email |
kumarhomoeopaths@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tantia University sri ganganagar district hanumangarh state rajasthan 335001 India |
|
|
Primary Sponsor
|
| Name |
Tantia University |
| Address |
Principal Office Ground Floor Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute |
| 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 Harshit Kumar |
OPD of Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute |
Repertory Department of Homoeopathic Medical College Hospital And Research Institute Near RIICO Bus Stand Hanumangarh Rd , Sri Ganganagar, Rajasthan,335001
Ganganagar
RAJASTHAN |
7983017630
kumarhomoeopaths@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Homoeopathic |
Placebo |
| Intervention |
Homoeopathic medicine |
Pills from oral route administration First dose at the time of case taking Subsequent doses according to the follow ups |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with Migraine either with or without aura.
2. Willing to pareticipate with informed concent |
|
| ExclusionCriteria |
| Details |
1. Patient on long term allopathic treatment for any of the disease
2. Other types of headache (tension , cluster, secondary)
3.Patient with psychiatric or neurological disorder
4. Patient undergoing any surgery
5. Patient with severe neuro-systemic disease, pregnant ladies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes will be observed on Migraine Disability Assessment Scale (MIDAS) measuring pain intensity
changes can be positive , negative or no change |
12 months study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Health related quantity of life |
12 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
27/11/2025 |
| 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 Applicable |
| 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
|
This study is to assess the impact of medicine selected from Repertory of homoeopathic materia medica by J T Kent for the treatment of migraine
sample size 96
12 months study
scale used - Migraine Disablity Assesment Scale (MIDAS)
It is expected to give positive changes |