| CTRI Number |
CTRI/2024/10/075323 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study of Diet and regimen along with homoeopathic management of migraine |
|
Scientific Title of Study
|
A single blind non randomised control trial to study the role of diet and regimen with homoeopathic management of migraine in the age group of 18-50 years |
| 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 Divya Misra |
| Designation |
Doctor, PG Scholar |
| Affiliation |
BVDU Homoeopathic medical college and hospital,Pune,Maharashtra |
| Address |
Bharati Vidyapeeth(Deemed to be university) Homoeopathic medical
college and hospital, Dept of post graduate and research Centre,
Pune-Bangalore highway, Pune,411043 Maharashtra, India.
Pune
MAHARASHTRA
411043
India |
| Phone |
6394798227 |
| Fax |
|
| Email |
divyamisra417@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AssProfDrPoonam Ganesh Kakandikar |
| Designation |
MD(HOM), Ass. Prof. Dept. of Organon of Medicine |
| Affiliation |
BVDU Homoeopathic medical college and hospital |
| Address |
Bharati Vidyapeeth(Deemed to be university) Homoeopathic medical
college and hospital, Dept of post graduate and research Centre,
Pune-Bangalore highway, Pune,411043 Maharashtra, India.
Pune
MAHARASHTRA
411043
India |
| Phone |
8623889128 |
| Fax |
|
| Email |
poonam.kakandikar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
AssProfDrPoonam Ganesh Kakandikar |
| Designation |
MD(HOM), Ass. Prof. Dept. of Organon of Medicine |
| Affiliation |
BVDU Homoeopathic medical college and hospital |
| Address |
Bharati Vidyapeeth(Deemed to be university) Homoeopathic medical
college and hospital, Dept of post graduate and research Centre,
Pune-Bangalore highway, Pune,411043 Maharashtra, India.
Pune
MAHARASHTRA
411043
India |
| Phone |
8623889128 |
| Fax |
|
| Email |
poonam.kakandikar@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth(deemed to be university) Homoeopathic Hospital and research centre,Pune-Satara Road,Dhankawadi,Katraj,Pune-411043,Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr.Divya Misra |
| Address |
Bharati vidyapeeth(deemed to be university)Homoeopathic Medical
college and hospital, Dept of post graduation and research centre
Pune Bangalore highway, Pune, 411043 |
| 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 |
| Dr Poonam Ganesh Kakandikar |
Bharati Vidyapeeth Homoeopathic Hospital and Research Centre |
Room no.3 ,Department of Organon of Medicine,Bharati Vidyapeeth homoeopathic hospital OPD
Pune
MAHARASHTRA |
8623889128
poonam.kakandikar@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bharati Vidyapeeth (DTU) HMC, Pune |
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 |
Diet Advice |
15 patients-study group
Individual diet chart
18 months
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria
Patients opting for homoeopathic treatment for their illness
Patients complying for regular follow up
Patients in the age group 18-50 years
Patients willing to give voluntary informed consent for the study |
|
| ExclusionCriteria |
| Details |
Patients who require emergency medical treatment
Patients undertaking any other mode of treatment along with homoeopathic mode of treatment
Pregnant and lactating women would not be included in the study
Patients who are suffering from any systemic illness other than migraine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the role of diet and regimen in management of cases of migraine |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of homoeopathic medicines in the treatment of migraine |
18 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/10/2024 |
| 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="1"
Months="6"
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
|
Migraine is characterized by recurrent attacks of disabling headaches,often accompanied by sensory and motor disturbances.Clinical manifestations of migraine are influenced by dietary behaviors and dietary elements.Several dietary triggers for migraine have been identified,leading to the definition of strategies such as elimination diets,ketogenic diets and comprehensive diets,mainly to help prevent migraine.
|