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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [romalpadsumbiya1999@gmail.com].

  6. 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.

  7. 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 Likes”(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.

 

 
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