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CTRI Number  CTRI/2022/07/044049 [Registered on: 15/07/2022] Trial Registered Prospectively
Last Modified On: 12/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homoeopathic treatment of Migraine 
Scientific Title of Study   Efficacy of Individualized Homoeopathic Medicines for Migraine among adults; Double blind, Randomized, Placebo controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1280-0725  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hanuman Ram 
Designation  PhD Scholar 
Affiliation  Homoeopathy University, Jaipur, Rajasthan 
Address  Dr M.P.K. Homoeopathic Medical College, Hospital and Research Center, Homoeopathy University, Saipura, Sanganer, Jaipur, Rajasthan.

Jaipur
RAJASTHAN
302029
India 
Phone  9462279933  
Fax    
Email  drhrchoudhary@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonia Tuteja 
Designation  Professor, Dept. of Homoeopathic Materia Medica 
Affiliation  Homoeopathy University, Jaipur, Rajasthan 
Address  Dr M.P.K. Homoeopathic Medical College, Hospital and Research Center, Homoeopathy University, Saipura, Sanganer, Jaipur, Rajasthan.

Jaipur
RAJASTHAN
302029
India 
Phone  9530454132  
Fax    
Email  drsoniatuteja@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Hanuman Ram 
Designation  PhD Scholar 
Affiliation  Homoeopathy University, Jaipur, Rajasthan 
Address  Dr M.P.K. Homoeopathic Medical College, Hospital and Research Center, Homoeopathy University, Saipura, Sanganer, Jaipur, Rajasthan.


RAJASTHAN
302029
India 
Phone  9462279933  
Fax    
Email  drhrchoudhary@gmail.com  
 
Source of Monetary or Material Support  
Madhav Homoeopathic Medical College and Hospital, Abu Road, Rajasthan. 
 
Primary Sponsor  
Name  None  
Address  Nil 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
None  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 Hanuman Ram  Madhav Homoeopathic Medical College and Hospital  Department of Homoeopathic Materia Medica, Madhav Homoeopathic Medical College and Hospital, Madhav Hills, Opp. Banas River Bridge Toll N.H. 27, P.O. Bharja, Abu Road, Rajasthan 307026.
Sirohi
RAJASTHAN 
9462279933

drhrchoudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Homoeopathy University, Jaipur, Rajasthan  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 
Intervention  Individualized Homoeopathic Medicines  Administration of indicated homoeopathic medicines in centesimal potencies as per the need of the patient and as decided appropriate by the investigator. Each dose of centesimal scale consisted of 4 cane sugar globules no. 30 medicated with the indicated medicine (preserved in 90% v/v ethanol), orally on a clean tongue. The dosage and repetition depending upon the individual requirement of the case. The duration of treatment for each subject will be 06 months. All medicines will be procured from a Good Manufacturing Practice-certified firm. Final selection of the single individualized medicine and dosage will be in accordance with standard homoeopathic guidelines. The prescriptions on follow-up visits will be generated as per relevant homoeopathic principles and recorded in follow-up sheets. Homoeopathic prescriptions may be changed during the study as and when required in adherence with homoeopathic principles. Each patient will be given general advices on lifestyle management by controlling trigger factors, like maintaining regularity of regimen with regard to meals, psychological counseling for reduction of stress, depression and anxiety, regular physical exercise and wake-sleep habits, and maintenance of headache diary to enhance awareness of events that bring on headache. 
Comparator Agent  Placebo  Placebo will be identical in appearance with and indistinguishable from the medicine. Each dose of placebo shall consist of 4 cane sugar globules no. 30 moistened with rectified spirit, to be taken orally on clean tongue. The dosage and repetition depending upon the individual requirement of the case. The duration of treatment for each subject will be 06 months. Each patient will be given general advices on lifestyle management by controlling trigger factors, like maintaining regularity of regimen with regard to meals, psychological counseling for reduction of stress, depression and anxiety, regular physical exercise and wake-sleep habits, and maintenance of headache diary to enhance awareness of events that bring on headache. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Subjects who has diagnosed as per the International classification of Headache disorders diagnostic criteria - 3 for Migraine.
2. Subjects will be selected irrespective of their sex, socio-economic status and occupation.
3. Age between 18 to 50 years.
4. If the subject is illiterate then the relatives or family members will be assessed to fill the headache diary.
5. Subjects who are willing to participate and sign the written informed consent form.
 
 
ExclusionCriteria 
Details  1. Subjects suffering from the complications of migraine.
2. Suspected secondary headache (trauma, headache attributed to vascular or non vascular intracranial disorders, medication overuse headache, hypertension).
3. Subjects are undergoing treatment with non-steroidal anti inflammatory drugs (NSAIDS), antiemetic, triptans, ergot alkaloids and oestrogen during 2 weeks prior to enrollment in the study.
4. Subjects suffering from uncontrolled systemic illness or psychiatric diseases and/or life-threatening infections.
5. Substance abuse and/or dependence.
6. Pregnant or lactating women.
7. Subjects already undergoing homoeopathic treatment elsewhere for any chronic disease within last 02 months.
8. Non-compliance to the study treatment/ protocol.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Diagnostic Headache Diary (DHD)  Baseline, every month, up to 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Migraine Disability Assessment Questionnaire (MIDAS)  Baseline, 3 months, 6 months 
EQ-5D-5L and EQ-VAS Questionnaire  Baseline, 3 month, 6 months 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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/ Phase 3 
Date of First Enrollment (India)   18/07/2022 
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   None yet; to be published  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Migraine is a common disabling primary headache disorder. Previous epidemiological studies have documented its high prevalence and socio-economic and personal impact in quality of life of an individual. It affects ~15% of the population, during the formative and most productive periods of their lives between the ages of 22 and 55 years. In the Global Burden of Diseases (GBD) 2010, it was ranked as the third most prevalent disorder in the world. In GBD 2015, it was ranked the third-highest cause of disability worldwide in both males and females under the age of 50 years. Patient suffering as well as recommendations to start conventional medication early have resulted in headaches from medication overuse, which is a major health problem (not in the least from the side-effects) with a prevalence of about 1%. However, the conventional treatment are not always fully effective and some have marked adverse effects. Because of this, many patients suffering from migraine may try alternative therapies such as homeopathy. Homeopathy may hold promise in successful treatment of migraine, but has remained under/poor researched. In this double-blind, randomized, placebo-controlled, clinical trial at Madhav Homoeopathic medical college and hospital, Abu road, Rajasthan 86 patients will be randomized to either individualized homoeopathic medicines or placebo to examine whether individualized homoeopathic medicines have any different effect from placebo in treatment of migraine. The frequency, duration and intensity of migraine attack will be assessed at baseline, every month and up to the 06 month by Diagnostic Headache Diary (DHD). The Migraine disability and quality of life of patients will be assessed at baseline, 03 months and after 06 months by Migraine Disability Assessment Questionnaire (MIDAS), EQ-5D-5L and EQ-VAS Questionnaire scores. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.

 
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