| CTRI Number |
CTRI/2024/05/067106 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy Preventive Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Utility of Homoeopathy in Migraine |
|
Scientific Title of Study
|
A Prospective Interventional Study To Ascertain The Effectiveness Of Homoeopathic Medicines In Cases Of Migraine Assessed By Midas Scale |
| 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 Romal Padsumbiya |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homeoeopathic Medical College |
| Address |
Department of Materia Medica, Rajkot Homeoeopathic Medical College, Behind Jaynath complex, Makkam Chowk, Gondal Road, Rajkot, Gujarat, India
Rajkot GUJARAT 360002 India |
| Phone |
9574582972 |
| Fax |
|
| Email |
romalpadsumbiya1999@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajesh Sanja |
| Designation |
HOD / Professor |
| Affiliation |
Rajkot Homeoeopathic Medical College |
| Address |
Department of Materia Medica, Rajkot Homeoeopathic Medical College, Behind Jaynath complex, Makkam Chowk, Gondal Road, Rajkot, Gujarat, India
Rajkot GUJARAT 360002 India |
| Phone |
9825885350 |
| Fax |
|
| Email |
rajesh.sanjarhmc@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Romal Padsumbiya |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homeoeopathic Medical College |
| Address |
Department of Materia Medica, Rajkot Homeoeopathic Medical College, Behind Jaynath complex, Makkam Chowk, Gondal Road, Rajkot, Gujarat, India
Rajkot GUJARAT 360002 India |
| Phone |
9574582972 |
| Fax |
|
| Email |
romalpadsumbiya1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College |
| Address |
Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot |
| 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 Romal Padsumbiya |
Rajkot Homeopathic Medical College |
Department of Materia Medica, Rajkot Homeoeopathic Medical College, Behind Jaynath complex, Makkam Chowk, Gondal Road, Rajkot, Gujarat, India Rajkot GUJARAT |
9574582972
romalpadsumbiya1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College (RHMC), Parul University, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G431||Migraine with aura, (2) ICD-10 Condition: G430||Migraine without aura, (3) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized homoeopathic
medicine.
Mode of Administration: Oral
(sublingual) Selection of
potency, dose and repetition :
individualized medicine will be
prescribed in 30, 200, 1 M
potency. selection of dosage,
potency and repetition will be
according to susceptibility of
patient and principles of
organon of medicine and will be done every week after follow up till 6 months |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18 to 60 years.
2. Sex: Both male and female and from all socio-economy will be included.
3. Pre diagnostic cases of migraine or new cases fulfilling the ICDH-3 criteria
for migraine.
4. Patient who are willing to take homoeopathic medicine.
|
|
| ExclusionCriteria |
| Details |
1. Age: Less than 18 years and more than 60 year.
2. Patient with migraine who are on other therapeutic measures
3. Secondary headache, other chronic illness and psychiatric illness
4. Pregnancy and lactating mother.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To ascertain the effectiveness of homoeopathic medicines in cases of migraine.
To ascertain the effectiveness of homoeopathic medicine in case migraine with the help of Midas Scale.
To evaluate the reduction in intensity and frequency of migraine in patient who will undergoing homoeopathic treatment |
There will be some improvement after
prescribing Homoeopathic Medicines which will be assessed at every 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Response will be analyze into 4 criteria
1. Marked improvement: Decrease in intensity / frequency of complaints
More than 76% according to MIDAS score.
2. Moderate improvement: Decrease in intensity / frequency of complaints
between 51 to 75% according to MIDAS score.
3. Mild improvement: Decrease in intensity / frequency of complaints
between 26 to 50% according to MIDAS score.
4. No improvement: Decrease in intensity / frequency of complaints less than
25% according to MIDAS score.
|
there will be some improvement after prescribing
homoeopathic medicines after 9 months |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
27/05/2024 |
| 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="0" Months="9" 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 - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 - Proposals should be directed to [romalpadsumbiya1999@gmail.com].
- For how long will this data be available start date provided 01-06-2024 and end date provided 31-05-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NO ANY
|
|
Brief Summary
|
| NEED FOR THE STUDY Migraine is a genetically influenced complex disorder characterized by episodes of moderate-to-severe headache, most often unilateral. The word migraine is derived from the greek word ‘’hemikrania,’’ which later was converted into latin as ‘’hemigranea.’’ The French translation of such a term is ‘’migraine.’’ The most common type of migraine is without aura(75% of cases).(1) Migraine is the second most common causes of headache, and the most common headache realted & indeed neurological causes of disability in the word, afflicts 15% of women and 6% of men over a 1 year period.(2) migraine is the first among the cause of disability in women under 50 years of age.(3) Incidence increases and peaks during the 3rd decade of life and then decrease.(4) According to global burden of disease(GBD) 2019 study, the estimated global prevalance of Migraine increased from 721.9 million in 1990 to 1.1 billion in 2019.(5) In India, The age Standardized 1 year prevalence of migraine was 25.2% prevalence was higher among female than males & among those from rural areas than urban.(6) Migraine is usually an episodic and occur due to increase sensitivity to certain things like sound, light, movement and also triggers by mental or physical stimuli such as stress, anxiety, hormonal changes, visual stimuli(bright light, glare), auditory stimuli (music, loud noise), olfactory stimuli(perfumes, strong smell), sleep disturbance, and hunger. In conventional mode of treatment is to avoidance of identified triggers or exacerbating factors or gives analgesic & anti-inflammatory agents.(7) But this treatment is mainly concerned with the acute suffering but it is not enough for recurrence and repeated attack and only give a temporary relief in complaints. Homoeopathy is mode of treatment based on the principle and universal law-“Like Cure Likesâ€(Similia Similibus Curenter) and a simillimum prescribed on the basis of individuality and ‘Totality of Symptoms’ that is the symptoms similarity. So homeopathic medicine not just treats the disease but it treats the patient as whole. So In case of migraine homoeopathic treatment may prove better because it is not only relieves the pain but it aslo decrease the sensitivity to triggering factors. It reduce the frequency of migraine attack and prevent the recurrence by eliminating it’s roots and help to lead a happy and pain free life. Homoeopathic treatment for migraine does not just treat migraine but also improve the overall health, quality of life and well being of patient. So I want to study the effect of homoeopathic medicine in case of migraine selected on basis of symptoms similarity. | |