Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402605784366 Date of Registration: 02/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Amitriptyline versus nutraceuticals in vestibular migraine managment
Official scientific title Amitriptyline versus nutraceuticals in the prophylaxis of vestibular migraine: randomized controlled study
Brief summary describing the background and objectives of the trial The mechanisms underlying VM are not fully understood so different types of drugs are utilized in the prophylaxis of VM including calcium channel blockers , β-blockers ,antiepileptic and antidepressants (3) It's crucial to compare between different drugs used in the prophylaxis of VM to find out the most effective drugs with the fewest adverse effects. The use of effective prophylactic medications for anxiety will be of great value in the management of VM as VM symptoms interfere with daily living activities due to the lack of balance confidence with limiting functional abilities which may cause anxiety also anxiety can precipitate VM symptoms (4).Nutraceuticals ( Magnesium, riboflavin, coenzyme Q10 )have been used in management of VM(5) . However, no randomized clinical trials for their effectiveness exist so this study aims to compare the efficiency of medications used for VM prophylaxes which are amitriptyline and nutraceuticals.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/06/2023
Actual trial start date 15/06/2023
Anticipated date of last follow up 15/03/2024
Actual Last follow-up date 15/04/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Patients managed only by dietary and life style modifications 3 months Dietary modifications and restrictions of some foods e.g Caffeine Chocolates, artificial sweeteners, processed meats and aged cheese were suggested to all subjects participating in the current study in addition to sleep regulation , walking activities (for at least 30 min per day) 20 Active-Treatment of Control Group
Experimental Group Patients treated with amitriptyline 10 mg PO daily once at noonvand the dose will be increased to 25 mg per day after 2 weeks if the drug is tolerated . 3 months 10 mg PO daily at noon and before bedtime (twelve hours before the time of getting up) and the dose will be increased to 25 mg per day after 2 weeks if the drug is tolerated by the patients and side effects like drowsiness and dry mouth were not reported. 20
Experimental Group Nutraceuticals riboflavin 400 mg daily, coenzyme-Q10 150 mg daily, magnesium 400–600 mg daily 3 months riboflavin 400 mg daily, coenzyme-Q10 150 mg daily and magnesium 400–600 mg daily are given for 3 months 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients diagnosed with vestibular migraine according to the diagnostic criteria of the International Classification of Headache Disorders (ICHD diagnostic criteria, 2018). -patients in the age range of 18 to 60 years either males or females. - Available method of communication like email ,cell phone or whatsaap. 1-Patients with a known history of allergic reaction to amitriptyline ,co enzyme 10 .riboflavin and magnusuim 2-Patients with a significant illness or medical condition such as cancer, cardiac diseases,neuropychiatric disorders ,liver, or kidney failure. 3-Patients with history of gastrointestinal distrbances that affect absorption and metabolism of drugs. 4- Pregnant or lactating females. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/06/2023 Menoufia University Faculty of Medicine reserch Ethics Committtee
Ethics Committee Address
Street address City Postal code Country
Gamal Abdel naser street Shebin EL kom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual Analog Scale (VAS) prior to prophylactic treatment and after 3 months from the intervention
Secondary Outcome The number and duration (hours) of vestibular symptoms / migraine attacks will be evaluated. prior to prophylactic treatment and after 3 months from the intervention
Secondary Outcome Arabic version of Dizziness handicap inventory prior to prophylactic treatment and after 3 months from the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Audiovestibular medicine unit faculty of medicine Menoufia university Gamal Abdel Naser street Shebin Elkom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufia university hospital Gamal Abd Elnaser Shebin el Kom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of mediicne Menoufia university hospitals Gamal Abdel Naser street Shebin EL kom 32511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asmaa Moaty asmaa82@yahoo.com +2001002056491 Gamal Abdel Naser street
City Postal code Country Position/Affiliation
Shebin EL kom 32511 Egypt Associate professor
Role Name Email Phone Street address
Public Enquiries Asmaa Moaty asmaa82@yahoo.com +2001002056491 Gamal Abdel Naser street
City Postal code Country Position/Affiliation
Shebin EL kom 32511 Egypt Associate professor
Role Name Email Phone Street address
Scientific Enquiries Asmaa Moaty asmaa82@yahoo.com +2001002056491 Gamal Abdel Naser street
City Postal code Country Position/Affiliation
Shebin EL kom 32511 Egypt Associate professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participants data that underlie the results reported in this article after de identification(text,tables,figures andappendices) Statistical Analysis Plan,Study Protocol Beginning 9 months and ending 36 months following article publication -For researchers who provide a methodologically sound proposal -To achieve aims in the approved proposal -proposals should be directed to asmaa82@yahoo.com.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information