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IRCT20170317033107N3 IRCT 2020-01-11 Mashhad University of Medical Sciences Effectiveness of Persian herbal formulation on migraine associated with functional dyspepsia no Investigating migraine from the perspective of Persian traditional medicine and the effectiveness of Persian herbal formulation on migraine associated with functional dyspepsia 2017-05-22 anticipated 90 Complete https://irct.ir/trial/25626 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individualized randomization with statistical software, Blinding description: This study was a double-blind clinical trial in which patients and researchers were not informed of the treatment group and when entered into the Persian traditional pharmacy of Imam Reza Hospital and apothecary after viewing the number and referring to the numbers table and determining treatment group the medication was given 3 months each 15 days separately. 3 migraine associated with functional dyspepsia. Intervention 1: Intervention group 1": Three capsules of 750 mg of Persian Traditional Medicine Product (Contains Ginger, Amelah, Rose, Coriander) three times a day plus Depakin (Sanofi pharmaceutical company) two tablets of 200 mg each day and amitriptyline ( Iran daroo pharmaceutical company) 1 tablet 10 mg once a day all of them for three months. Intervention 2: "Intervention group 2": Three capsules of 750 mg of Persian Traditional Medicine Product (Contains Ginger, Amelah, Rose, Coriander) three times a day plus Depakin placebo tablet twice a day. Intervention 3: "Control group": Three placebo capsules of 750 mg as like as Traditional Medicine Product capsules three times a day plus Depakin tablets 200 mg twice a day and amitriptyline tablet 10 mg once a day. Yes - There is a plan to make this available What will be shared: The spss file contains the following information from the participants: demographic information HIT-6 questionnaire and parkman criteria scores When: 6 month after publication of results To whom: The data is only accessible to researchers working in academic centers Conditions: New research on the data of this study is allowed with the written permission of the corresponding author Where to obtain: Contact corresponding author of the published article, Dr. Majid Anushiravani via following email address: dr.anushiravani@gmail.com How to obtain: 1. send a request to corrsponding author via an academic email address 2. Check the request by corresponding author 3. If applicable, send the data file by email Comments:
public Ali Gholampour
Emam Reza hospital
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3884 8930 Gholampoura1@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Majid Anushirvani
East door of Ferdowsi University, School of Persian and complementary medicine
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3884 8930 dr.Anushiravani@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Migraine headache concurrently with functional dyspepsia Migraine headache criteria based on the latest version and presentation of dyspepsia 17 years 55 years Both Headache with non diagnosis of migraine Stomach disorder with non diagnosis of functional dyspepsia G43, G43.1 Migraine without aura [common migraine], Migraine with aura [classical migraine] Migraine: aura without headache basilar equivalents familial hemiplegic with: acute-onset aura prolonge Treatment - Drugs Treatment - Drugs Placebo Intervention group 1": Three capsules of 750 mg of Persian Traditional Medicine Product (Contains Ginger, Amelah, Rose, Coriander) three times a day plus Depakin (Sanofi pharmaceutical company) two tablets of 200 mg each day and amitriptyline ( Iran daroo pharmaceutical company) 1 tablet 10 mg once a day all of them for three months. "Intervention group 2": Three capsules of 750 mg of Persian Traditional Medicine Product (Contains Ginger, Amelah, Rose, Coriander) three times a day plus Depakin placebo tablet twice a day. "Control group": Three placebo capsules of 750 mg as like as Traditional Medicine Product capsules three times a day plus Depakin tablets 200 mg twice a day and amitriptyline tablet 10 mg once a day. Headache frequency. Timepoint: Baseline and after 4, 8 and12 weeks of intervention. Method of measurement: Number of episodes in month. Headache duration. Timepoint: Baseline and after 4, 8 and12 weeks of intervention. Method of measurement: Duration of each episode (in hour). Headache severity. Timepoint: Baseline and after 4, 8 and12 weeks of intervention. Method of measurement: Visual Analog Scale. Severity of functional dyspepsia. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Parkman's criteria. Effect of headache on quality of life. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: HIT-6 questionaire. Mashhad University of Medical Sciences Approved 2017-02-25 Ethics committee of Mashhad University of Medical Sciences Central Organization of Mashhad University of Medical Sciences, Daneshgah St. Mashhad Razavi Khorasan Iran (Islamic Republic of)