Protocol summary

Study aim
Determining the Effect of Dietary Recommendations in Persian Medicine on the Improvement of Headaches in Patients with Headache and Functional Dyspepsia.
Design
This clinical trial uses a parallel-group control design with single-blind methodology, involving 160 eligible patients. After assessing headache severity and functional dyspepsia in the pre-intervention phase, participants are categorized into four quartiles based on similar headache scores. They are then randomly assigned to two groups using a 40-block sequence, each marked with the letters A or B.
Settings and conduct
We will use convenience sampling from individuals referred to government hospitals affiliated with Babol University of Medical Sciences who have undergone endoscopy. In the intervention group, we'll provide training in both Iranian traditional medicine and conventional medicine to improve dyspepsia and associated headaches, while the control group will receive training in conventional medicine for the same purpose. Both groups will also receive their standard treatments. This approach creates a form of single-blind study design, as participants won't be aware of each other's training content.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Presence of functional dyspepsia 2. Age between 18 and 60 years 3. Presence of primary headaches Exclusion criteria: 4. Use of medications causing headaches or gastrointestinal damage 5. Presence of gastrointestinal diseases 6. Presence of secondary headaches
Intervention groups
1. In the intervention group, dietary and beverage practices will be instructed based on the fundamentals of Persian medicine in conjunction with conventional medicine. 2. In the control group, dietary and beverage practices will be instructed based on conventional medicine principles.
Main outcome variables
Treating Dyspepsia-Related Headaches in Patients with Functional Dyspepsia.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220606055085N1
Registration date: 2023-09-09, 1402/06/18
Registration timing: prospective

Last update: 2023-09-09, 1402/06/18
Update count: 0
Registration date
2023-09-09, 1402/06/18
Registrant information
Name
Morteza Mojahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 4730
Email address
mortazamojahedy@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Persian medicine's dietary recommendations on improving headaches in patients with both headaches and functional dyspepsia.
Public title
The impact of dietary recommendations from Persian medicine on alleviating headaches caused by dyspepsia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Science
Street address
Sargord Ghasemi Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2023-08-06, 1402/05/15
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.062

Health conditions studied

1

Description of health condition studied
Headache caused by indigestion
ICD-10 code
G44.2
ICD-10 code description
Tension-type headache

2

Description of health condition studied
Headache caused by indigestion
ICD-10 code
G43
ICD-10 code description
Migraine

Primary outcomes

1

Description
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)

Secondary outcomes

1

Description
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.

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rouhani Hospital
Full name of responsible person
Morteza mojahedi
Street address
Sargord Ghasemi Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8284
Email
mortazamojahedy@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Morteza Mojahedi
Street address
Sargerd Ghasemi St. - Keshavarz Blvd
City
Bbol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8284
Email
mortazamojahedy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Morteza Mojahedi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sargord Ghasemi Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4730
Email
mortazamojahedy@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Morteza Mojahedi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sargord Ghasemi Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4730
Email
mortazamojahedy@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Morteza Mojahedi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sargord Ghasemi Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4730
Email
mortazamojahedy@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information available.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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