]>
IRCT20231009059670N1 IRCT 2024-02-19 Kashan University of Medical Sciences Comparison effect of migroherb herbal drug( Tanacetum parthenium, Matricaria chamomilla and magnesium) and Venlafaxine in migraine Comparison effect of migroherb herbal drug( Tanacetum parthenium, Matricaria chamomilla and magnesium) and Venlafaxine on the severity and frequency of headache and the quality of life of migraine sufferers 2023-12-06 anticipated 70 Complete https://irct.ir/trial/73621 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by block method (Permuted block randomization) so that first all 4 blocks containing two codes A and B are prepared (4 blocks) then random blocks are selected by placement using a table of random numbers. 26 blocks) These blocks form a sequence of 104 A and B codes, each code is randomly assigned to one of the groups, Blinding description: Medicines are made and prepared in Barij Essan Pharmaceutical Company in the same packaging, appearance and size. Then they are coded based on the codes that have been previously prepared using a table of random numbers. The doctor prescribes the coded drug for each group without knowing the type of each code. The data collector and the data analyzer also Based on the type of code, two groups will be monitored until the study is completed. 3 migraine. Intervention 1: Intervention group: The recipient of venlafaxine capsules 37.5 mg daily along with sodium valproate 200 mg daily. The duration of this intervention is three months. Intervention 2: Intervention group: Recipient of miÙ„roherb capsules (containing 50 mg of magnesium, 100 mg of feverfew, 150 mg of Matricaria chamomilla) produced by Barij Essence Company, which should be taken every 12 hours with plenty of water, and 200 mg sodium valproate tablets daily. The duration of this intervention is three months. Yes - There is a plan to make this available What will be shared: Data file of participants (except personal information including age and phone number) When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: For use in research to improve the treatment process of migraine sufferers on the condition of mentioning the source of the received information and preserving the principle of trustworthiness Where to obtain: Hodasadat Homayouni mobile :09132283085 email : hoda.homayoni91@gmail.com How to obtain: A clear explanation of the reason and purpose of needing to access information Comments:
public Hodasadat Homayouni
plate 13;Aftab dead end; alley 13;1st Apadana street; Isfahan
Kashan Iran (Islamic Republic of) 8165886741 +98 31 3661 7507 hoda.homahoni91@gmail.com Kashan University of Medical Sciences scientific Hodasadat Homayouni
plate 13;Aftab dead end; alley 13;1st Apadana street; Isfahan
Kashan Iran (Islamic Republic of) 8165886741 +98 31 3661 7507 Hoda.homayoni91@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Ages 18-65 years Confirmation of episodic migraine by a neurologist according to the latest ICHD definition 18 years 65 years Both Use of corticosteroids Use of vitamin D, calcium and riboflavin supplements Using other anti-migraine drugs (including beta-blockers, anti-seizures, calcium blockers, tricyclic antidepressants, nerve block or stimulation) except sodium valproate 200 mg daily Presence of tension headache Diagnosis of chronic migraine Having a history of liver, kidney and hyper parathyroid diseases Pregnancy and breastfeeding People with trigeminal autonomic cephalalgia and neuralgia People with secondary headaches Patients using OCP and undergoing HRT treatment Migraine headache onset age after 50 years Excessive consumption of alcohol and drugs Known cases of psychosis, major depression, bipolar disorder G43 Migraine Treatment - Drugs Treatment - Drugs Intervention group: The recipient of venlafaxine capsules 37.5 mg daily along with sodium valproate 200 mg daily. The duration of this intervention is three months. Intervention group: Recipient of miÙ„roherb capsules (containing 50 mg of magnesium, 100 mg of feverfew, 150 mg of Matricaria chamomilla) produced by Barij Essence Company, which should be taken every 12 hours with plenty of water, and 200 mg sodium valproate tablets daily. The duration of this intervention is three months. Impact on quality of life. Timepoint: At the beginning of the study (before the start of the intervention) and one month, two months and three months after the start of Migroherb or Venlafaxine. Method of measurement: HIT6 (Headache Impact Test) questionnaire. Headache attacks frequency. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of migroherb or venlafaxine. Method of measurement: MIDAS (Migraine Disability Assessment) questioner. Severity of headache attacks. Timepoint: At the beginning of the study (before the start of the intervention) and three months after the start of migroherb or venlafaxine. Method of measurement: MIDAS (Migraine Disability Assessment) questioner. Barijessence Pharmaceutical company Approved 2023-11-12 Ethics committee of Kashan University of Medical Sciences Ravandi street;Shahid beheshti hospital Kashan Isfehan Iran (Islamic Republic of)