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IRCT20220606055085N1 IRCT 2023-09-09 Babol University of Medical Sciences The impact of dietary recommendations from Persian medicine on alleviating headaches caused by dyspepsia. Investigating the effect of Persian medicine's dietary recommendations on improving headaches in patients with both headaches and functional dyspepsia. 2023-10-23 anticipated 160 Complete https://irct.ir/trial/72426 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are randomly block-assigned to two groups, intervention and control. After assessing the severity of headaches and functional dyspepsia in the pre-intervention phase and placing them in quartiles based on headache severity, they are then assigned to two groups (A and B) within each quartile using a random sequence of 40 quartet blocks, Blinding description: Both groups receive separate instructions, and individuals are unaware of the educational content delivered to the other group, creating a form of single-blind study design. N/A Condition 1: Headache caused by indigestion. Condition 2: Headache caused by indigestion. Intervention 1: Intervention Group: This group comprises 80 patients with headache caused by dyspepsia. These individuals undergo a 30-minute in-person training session conducted by a researcher. The educational content in Persian medicine includes dietary and beverage practices drawn from rich Persian medical sources. This material is presented in text and video formats for the participants' convenience. Additionally, individuals in this group continue their standard treatments and also receive conventional medical instructions for reducing dyspepsia. Follow-up assessments involve monitoring the severity of both headaches and dyspepsia. Intervention 2: Control Group: This group consists of 80 patients with headache caused by dyspepsia. These individuals receive a 30-minute, in-person training session with a researcher. The educational content for this group includes conventional medical instructions for reducing dyspepsia. The instructional materials are provided to patients in text and video formats. Participants in this group also continue to receive their standard treatments. Follow-up assessments involve monitoring the severity of both dyspepsia and headaches. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information available.
public Morteza Mojahedi
Sargord Ghasemi Avenue
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 4730 mortazamojahedy@gmail.com Babol University of Medical Sciences scientific Morteza Mojahedi
Sargord Ghasemi Avenue
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 4730 mortazamojahedy@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) The presence of functional dyspepsia, determined by the use of diagnostic tools and the assessment of a gastroenterologist, including endoscopy. At least 3 months of gastrointestinal symptoms have elapsed. Age should be between 18 and 60 years old. The presence of primary headaches, including tension-type headaches and migraines, based on the ICHD3 criteria, confirmed by a physician. The presence of a minimum of 3 headache attacks per month. The patient should have had headaches for at least 3 months. 18 years 60 years Both The patient should have been using medications regularly or daily, either currently or during the past 3 months, that can lead to gastrointestinal damage, such as aspirin and non-steroidal anti-inflammatory drugs (NSAIDs). The regular and daily use of medications that can potentially trigger headaches, such as nitroglycerin, type 5 phosphodiesterase inhibitors (such as sildenafil), and others. The presence of other gastrointestinal conditions such as gastric ulcers, inflammatory gastrointestinal diseases, or malignant gastrointestinal diseases confirmed through endoscopy. The presence of secondary headaches confirmed by a specialist. (Secondary headaches are one of the symptoms of another underlying primary condition that the patient has, such as malignancies, cerebral aneurysms, hypertension, meningitis, etc.). The presence of progressive or malignant diseases related to the central nervous system. The presence of other chronic conditions such as diabetes, uncontrolled and advanced hypertension, chronic obstructive pulmonary disease (COPD), etc. G44.2 G43 Tension-type headache Migraine Treatment - Other Treatment - Other Intervention Group: This group comprises 80 patients with headache caused by dyspepsia. These individuals undergo a 30-minute in-person training session conducted by a researcher. The educational content in Persian medicine includes dietary and beverage practices drawn from rich Persian medical sources. This material is presented in text and video formats for the participants' convenience. Additionally, individuals in this group continue their standard treatments and also receive conventional medical instructions for reducing dyspepsia. Follow-up assessments involve monitoring the severity of both headaches and dyspepsia. Control Group: This group consists of 80 patients with headache caused by dyspepsia. These individuals receive a 30-minute, in-person training session with a researcher. The educational content for this group includes conventional medical instructions for reducing dyspepsia. The instructional materials are provided to patients in text and video formats. Participants in this group also continue to receive their standard treatments. Follow-up assessments involve monitoring the severity of both dyspepsia and headaches. Headache Improvement Due to Dyspepsia. Timepoint: At the study's outset and then every two weeks until the eighth week. Method of measurement: 1. Headache Severity Assessment Checklist 2. Visual Analog Scale (VAS). Improve functional dyspepsia. Timepoint: At the study's initiation, and subsequently every 2 weeks up to the 8th week. Method of measurement: Dyspepsia Severity and Frequency Questionnaire. Babol University of Medical Sciences Approved 2023-08-06 Ethics committee of Babol University of Medical Science Sargord Ghasemi Avenue Babol Mazandaran Iran (Islamic Republic of)