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CTRI Number  CTRI/2024/07/070703 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy
Other (Specify) 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic Management in Cases of Migraine  
Scientific Title of Study   Clinical study in case of migraine with its homoeopathic management  
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 Saniya Parween 
Designation  PG Scholar Dept Practice of Medicine  
Affiliation  RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur  
Address  Room No 203 Department Practice of Medicine PG Building RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur
PG Building RBTS Govt Homoeopathic medical College and Hospital Muzaffarpur
Muzaffarpur
BIHAR
842002
India 
Phone  8444968616  
Fax    
Email  sanirahi1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Haresh Kumar Maharaj 
Designation  Associate Professor dept Practice of Medicine  
Affiliation  RBTS homoeopathic medical College and Hospital Muzaffarpur  
Address  Room no 203 Department Practice of Medicine PG Building RBTS Govt Homoeopathic Medical College and Hospital
Room no 203Department Practice of Medicine PG Building RBTS Govt Homoeopathic Medical College and Hospital
Muzaffarpur
BIHAR
842003
India 
Phone  7903899078  
Fax    
Email  drhareshkumarmaharaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Haresh Kumar Maharaj 
Designation  Associate Professor dept Practice of Medicine  
Affiliation  RBTS homoeopathic medical College and Hospital Muzaffarpur  
Address  Room no 203 Department Practice of Medicine PG Building RBTS Govt Homoeopathic Medical College and Hospital
Room No 203 Department Practice Of medicine PG Building RBTS Govt Homoeopathic Medical College and Hospital
Muzaffarpur
BIHAR
842002
India 
Phone  7903899078  
Fax    
Email  drhareshkumarmaharaj@gmail.com  
 
Source of Monetary or Material Support  
RBTS Govt Homeopathic Medical College and Hospital Muzaffarpur Bihar 842002 India 
 
Primary Sponsor  
Name  RBTS Govt Homoeopathic medical College and Hospital  
Address  Ramdayalu Nagar Muzaffarpur Bihar 842002 India 
Type of Sponsor  Government 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 Haresh Kumar Maharaj  RBTS Government Homoeopathic Medical College and Hospital  OPD No 1 Medicine Department OPD No 4 Surgery Department Hospital Block
Muzaffarpur
BIHAR 		 7903899078

drhareshkumarmaharaj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethical Committee of RBTS Govt Homoeopathic Medical College and Hospital Muzaffarpur Bihar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G892||Chronic pain, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Constitutional Homoeopathic Medicine prescribed after analyzing the totality of symptoms  after analyzing the totality of symptoms,repertorize with homeopathic repertory and prescribe a medicine. The potency and dose of medicine are selected according to the patients susceptibility. the patient was called for follow-up every 15 days or earlier if any new symptoms appeared. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 Symptomatic patient with positive findings of migraine will be included.
2 Patients willing to give consent to take part in the study will be included.

 
 
ExclusionCriteria 
Details  1 Patients below the age of 15 years will be excluded
2 Patients with psychiatric co-morbidities will be excluded
3 Systemic illnesses like hypertension, Diabetes, cardiac disease, Pregnant and Lactating women will be excluded.
4 Any pathological condition of the brain with a headache will be excluded.
5 Patients are not willing to give consent to take part in the study will be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
After the study, I anticipate that the instances of migraine will be classified by their individualized observational study and that we will be able to achieve some noticeable improvement in cases of migraine with the help of homeopathic individualized medicine.

 		 Assessment at baseline with regular intervals 2 weeks till 6 months.
 
 
Secondary Outcome  
Outcome  TimePoints 
To know the importance of individualized remedies indicating symptoms of migraine.
To use a scoring system to assess the quality of life in migraine.
To compare the symptomatic changes of patients before and after Homoeopathic treatment.
 		 1 Year 
 
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   Phase 4 
Date of First Enrollment (India)   26/07/2024 
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="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  

Migraine comes from the Greek word hemicrania, meaning “half of the head”. The synonyms for Migraine are Hemicrania or Megrim. The purpose of this study is to investigate the efficacy of homeopathic treatment for migraine headaches. This is accomplished by examining the patient’s assessment of the treatment in terms of the frequency, severity, and duration of their migraine attacks over time. Migraine can be defined as a benign and recurring syndrome of headache, nausea, vomiting, and or other symptoms of neurological dysfunction in varying admixtures

A careful review of the available Homoeopathic literature, as well as an exhaustive search, found a scarcity of original scientific work on related topics in homeopathy to date. So, there is room for improvement. The purpose of this research is to assess the efficacy of homeopathic individualized medicine in treating migraine, as well as to evaluate the effects on quality of life 
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