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CTRI Number  CTRI/2024/12/078628 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Homoeopathic medicine in migraine 
Scientific Title of Study   To compare the effectiveness of individualised homoeopathic medicine versus Chionanthus virginica mother tincture in management of migraine-A single Blind Randomised controlled trial. 
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 Aiswarya Mohan 
Designation  JUNIOR RESIDENT 
Affiliation  Nehru Homoeopathic Medical College And Hospital 
Address  Department of Materia Medica, Nehru homoeopathic medical College and Hospital, B block Defence colony, New Delhi

South
DELHI
110024
India 
Phone  8921403589  
Fax    
Email  aiswaryaala@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr George Mathew 
Designation  Professor 
Affiliation  Nehru Homoeopathic Medical College And Hospital  
Address  Department of Materia Medica, Nehru Homoeopathic Medical College And Hospital, B block Defence colony, New Delhi

South
DELHI
110024
India 
Phone  7982783132  
Fax    
Email  drgeorgem@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aiswarya Mohan 
Designation  JUNIOR RESIDENT 
Affiliation  Nehru Homoeopathic Medical College And Hospital 
Address  Department of Materia Medica, Nehru Homoeopathic Medical College And Hospital, B block Defence colony, New Delhi

South
DELHI
110024
India 
Phone  8921403589  
Fax    
Email  aiswaryaala@gmail.com  
 
Source of Monetary or Material Support  
Room no.11, outpatient Department of Nehru Homoeopathic Medical College and Hospital, B-block, Defence colony, New Delhi, 110024. 
 
Primary Sponsor  
Name  Dr Aiswarya Mohan 
Address  Nehru Homoeopathic Medical College And Hospital, B block Defence Colony, New Delhi, 110024 
Type of Sponsor  Other [[SELF]] 
 
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 Aiswarya Mohan  Nehru Homoeopathic Medical College and Hospital  Out patient department, room no.11, Nehru Homoeopathic Medical College and Hospital, B block Defence Colony, 110024
South
DELHI 		 8921403589

aiswaryaala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nehru Homoeopathic Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G439||Migraine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chionanthus Virginica mother tincture  A complete detailed case taking and repertorisation will be done according to the homoeopathic principles . As allocation of patients will be done by appropriate randomised procedure in 1:1 ratio, patient falling under this category will be receiving chionanthus virginica mother tincture. Route of administration is oral. Frequency of repetition will be done according to the improvement of symptoms.followup of the cases depending upon the severity of symptoms and as per the need and the necessity of the cases preferably fortnightly or once in a month. Duration of study is one year. 
Intervention  Individualised Homoeopathic Medicine  A compelete detailed case taking and repertorisation will be done according to homoeopathic principles and patient will recieve individualised homoepathic medicine as an intervention based on analysis, evaluation, and individualiastion of case. Dose will depend on severity of symptoms ranging from 30c, 200c and higher dose. Mode of administration is oral route, repetition will be done according to the improvement of symptoms take place. Followup of the cases depending upon the severity of symptoms and as per the need and the necessity of the cases preferably fortnightly or once in a month. Follow up of cases and study up to a period of one year. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients giving informed consent.
2.Have a history of migraine as defined by the International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2006) of at least 1 year prior to enrollment, migraine onset prior to age 50, and a moderate frequency of migraine headaches
3.Have clinical laboratory test results within normal reference ranges or, if outside the normal range, judged not clinically significant by the Investigator
4.Must not be on any migraine prevention therapy, including botulinum toxin (Botox)
5.Agree not to post any personal medical data related to the study or information related to the study on any website or social media site (for example, Facebook, Twitter, et cetera) until the trial has completed.
 
 
ExclusionCriteria 
Details  1.Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device, or concurrent enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study.
2.History of chronic migraine or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine.
3.History of headache (for example, cluster headache or Medication Overuse Headache [MOH]) other than migraine or tension type headache as defined by IHS ICHD-II within 12 months prior to randomization.
4.Diagnosed cases of psychiatric illness.
5.Pregnant women and lactating mothers.
6.Excessive alcohol, opiate, or barbiturate use; history of drug abuse or dependence.
7.Patients who are terminally ill, under immunosuppressive treatment or self-reported immunocompromised state.
8.Unwilling to take part and not giving consent to join the study or unable to read patient information sheet.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate which is more effective i.e., individualized homoeopathic medicine or Chionanthus virginica mother tincture in management of migraine.
2.To assess the improvement of patient in terms of frequency of attack and severity of symptoms of migraine.
 		 Initially at baseline and then fortnightly or monthly preferably up to one year.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the improvement in quality of life by using MIDAS SCALE.  Intially at baseline and then once in three months upto one year. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   05/01/2025 
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 is a disabling primary headache disorder characterized by attacks of unilateral throbbing headache, associated with photophobia, phonophobia, nausea, vomiting, or movement sensitivity, which may last for 4 to 72 hrs.
HYPOTHESIS:
• NULL HYPOTHESIS : There is no significant difference between the two comparable groups i.e. individualized HOMOEOPATHIC MEDICINE group and CHIONANTHUS VIRGINICA mother tincture group in management of migraine.
• ALTERNATIVE HYPOTHESIS : There is significant difference between two comparable groups i.e., individualized HOMOEOPATHIC MEDICINE group VERSUS CHIONANTHUS VIRGINICA mother tincture group in management of migraine.

1. PRIMARY OBJECTIVE
 To evaluate which is more effective i.e., individualized homoeopathic medicine or Chionanthus virginica mother tincture in management of migraine.
 To assess the improvement of patient in terms of frequency of attack and severity of symptoms of migraine.
2. SECONDARY OBJECTIVE
 To assess the improvement in quality of life by using MIDAS SCALE.
This study will be a prospective, parallel group, single blind, randomized controlled trial. simple random sampling will be used where patient will be randomly allocated in 1:1 ratio into 2 groups.individualized homoeopathic medicine treatment group or chionanthus virginica mother tincture treatment group. Patient recruitment will be done from OPD  of NHMC&H . 60 clinical cases of migraine will be taken as sample size of this study. Duration of study is of 1 year. Basis of prescription is a complete case taking and repertorisation will be done according to the homoeopathic principles. In case of individualized homoeopathic medicine , prescription will be based on analysis , evaluation and individualization of case. selection of potency and dosage will be based upon the severity of symptoms, susceptibilty of patient. Mode of administration will be oral. frequency of repetition depend upon the severity of symptoms, and as per the need and necessity of case preferably fortnight or monthly. final evaluation of results will be based on the basis of improvement in symptoms as well as by using Midas scale.

 
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