| CTRI Number |
CTRI/2024/05/067219 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicine in migraine |
|
Scientific Title of Study
|
SIGNIFICANCE OF MODALITIES FOR SELECTION OF HOMOEOPATHIC SIMILIMUM USING O.E.BOERICKES REPERTORY IN THE TREATMENT OF MIGRAINE-A PROSPECTIVE INTERVENTIONAL STUDY |
| 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 Pallavi Gupta |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital,1-Virajkhand ,Gomtinagar,Lucknow |
| Address |
Department of Case Taking and Repertory, State National Homoeopathic Medical College And Hospital, 1-Virajkhand, Gomtinagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
08931883661 |
| Fax |
|
| Email |
pallavi.gupta1114@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nutan Sharma |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College And Hospital,1-Virajkhand,Gomtinagar,Lucknow |
| Address |
Department of Practice of Medicine,State National Homoeopathic Medical College And Hospital,1-Virajkhand, Gomtinagar,Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
08178562292 |
| Fax |
|
| Email |
drnutansharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Gupta |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital,1-Virajkhand,Gomtinagar,Lucknow |
| Address |
Department of Case Taking and Repertory, State National Homoeopathic Medical College And Hospital, 1-Virajkhand, Gomtinagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
08931883661 |
| Fax |
|
| Email |
pallavi.gupta1114@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College And Hospital, 1-Virajkhand,Gomtinagar Lucknow-226010 |
|
|
Primary Sponsor
|
| Name |
Dr Pallavi Gupta |
| Address |
Department of Case Taking and Repertory,State National Homoeopathic Medical College And Hospital,1-Virajkhand, Gomtinagar,Lucknow, Uttar Pradesh-226010 |
| 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 Pallavi Gupta |
State National Homoeopathic Medical College And Hospital |
Opd Number 10,State National Homoeopathic Medical College And Hospital,1-Virajkhand, Gomtinagar,Lucknow, Uttar Pradesh-226010
Lucknow
UTTAR PRADESH |
08931883661
pallavi.gupta1114@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of State National Homoeopathic Medical College And Hospital |
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 |
Individualized homeopathic medicine |
Intervention is planned as
administering via oral route individualized
homoeopathic medicines to a group of 30 patients suffering from migraine
selected with the help of O.E.Boerickes Repertory, in varying potencies of
centesimal scale, as per the
requirement and direction of Dr.Hahnemann.Each dose shall consist of 4-5 globules of cane sugar medicated with single medicine(preserved in 90%v/v ethanol) to be taken orally on an empty stomach.Dosage and
repetition will be done according
to the case maintaining
homoeopathic principles.The patient will be called
for follow up after every 15 days
and the final assessment will be
done after 6 months.At every
follow up after reexamining the
case it will be decided whether
the patient will receive a dose of
individualized homoeopathic
medicine or placebo. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient giving consent to participate.
2)Having migraine for at least 1 year before treatment OR at least 5 prior attacks.
3)Cases which fulfill the international headache society criteria for migraine. |
|
| ExclusionCriteria |
| Details |
1) Patients with other primary headaches(cluster headache, tension headache)
2) Patients with secondary headache(Trauma, Hypertension)
3) Patients unwilling for inclusion in the study and those who are not able to come for follow up.
4) Patients with systemic illness such as malignancy, neurological, cardiovascular and metabolic condition.
5) Lactating and pregnant mother.
6) Persons with cognitive impairment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome measurement will be done by assessing the changes in MIDAS and HIT-6 score by considering severity of headache after each follow up in interval of one month gap
upto 6 month. |
4 weeks,24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
24/05/2024 |
| 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 an episodic neurological disorder that presents as a throbbing unilateral headache with nausea, phonophobia and photophobia, lasting for 4-72 hours.Migraine is a highly prevalent disorder,affecting 12% of the population, attacking up to 17% of women and 6% of men yearly.It is the third most prevalent disorder and seventh specific cause for disability worldwide.This is an open label ,single arm,prospective, interventional study which aims to assess the significance of modalities for selection of homoeopathic similimum using O.E.Boericke’s Repertory in the treatment of migraine.Individualized homoeopathic medicine will be prescribed in centesimal scale after detailed case taking and repertorization with the help of O.E.Boericke’s repertory.MIDAS Score and HIT-6 Score will be calculated every month upto 6 months.The difference between MIDAS score and HIT-6 score before and after treatment will be compared and analyzed. This study is undertaken to throw light into the significance of modalities for selection of homoeopathic similimum in treating the cases of migraine using O.E.Boericke’s Repertory.If the results will be positive, a certain group of remedies can be observed which are frequently indicated in cases of Migraine.There will be also improvement of mental health & behavior of the patient, with overall enhancement in the susceptibility & vitality of the patient. |