Investigating the Effect of Sumac Capsule Consumption on the Severity of Primary Dysmenorrhea and Quality of Life Among Female Students at the Asadabad School of Medical Sciences
Determining the Effect of Sumac Capsule Consumption on the Severity of Primary Dysmenorrhea
Design
Convenience sampling will be conducted among eligible students. Subsequently, written informed consent will be obtained from students who meet the inclusion criteria and are willing to participate, following an explanation of the research objectives. After the students are randomly assigned to the two study groups, a checklist regarding individual and obstetric demographic characteristics will be completed. The severity of primary dysmenorrhea and quality of life will be assessed at baseline (prior to the intervention) and again one and two months post-intervention, using the Visual Analog Scale (VAS) and a quality-of-life questionnaire.
Settings and conduct
After obtaining the necessary approvals from the Ethics Committee of the Asadabad Faculty of Medical Sciences, the researcher will visit the female dormitory. A convenience sampling method will be used to select eligible students.
Participants/Inclusion and exclusion criteria
Study inclusion criteria were: being single; residing in the Asadabad University of Medical Sciences dormitory; age 15–45 years; having a regular menstrual cycle (interval of 21–35 days and bleeding duration of less than 7 days)
Study exclusion criteria included: marriage; adverse reactions or allergy to sumac; occurrence of an untoward event; onset of illness; use of any herbal, chemical, or traditional medicine treatments during the intervention;
Intervention groups
Individuals take the capsules every 8 hours from day 1 to day 7 across two consecutive menstrual cycles.
Main outcome variables
Menstrual pain severity، quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150424021915N2
Registration date:2026-10-14, 1405/07/22
Registration timing:prospective
Last update:2026-10-14, 1405/07/22
Update count:0
Registration date
2026-10-14, 1405/07/22
Registrant information
Name
Azin Niazi
Name of organization / entity
Mashhad Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3340 9914
Email address
azin_niazi65@yahoo.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-11-22, 1405/09/01
Expected recruitment end date
2027-11-22, 1406/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Sumac Capsule Consumption on the Severity of Primary Dysmenorrhea and Quality of Life Among Female Students at the Asadabad School of Medical Sciences
Public title
Investigating the Effect of Sumac Capsule Consumption on the Severity of Primary Dysmenorrhea and Quality of Life Among Female Students at the Asadabad School of Medical Sciences
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single; residing in the Asadabad University of Medical Sciences dormitory; aged 15–45 years; having a regular menstrual cycle (intervals of 21–35 days and bleeding duration of less than 7 days); free from chronic diseases; not taking any medication affecting pain or the menstrual cycle; Body Mass Index (BMI) <30 kg/m²; self-reported absence of sumac allergy; no consumption of alcohol, cigarettes, or illicit drugs; self-reported absence of psychiatric disorders; and experiencing moderate to severe dysmenorrhea (VAS ≥4) for at least two days per menstrual cycle.
Exclusion criteria:
Marriage; an adverse reaction or sensitivity to sumac; occurrence of an untoward event; onset of illness; use of any herbal, chemical, or traditional medicine treatments during the intervention; failure to complete or incomplete completion of the VAS form; irregular medication use; and unwillingness to continue participation.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using balanced randomization blocks. The principal investigator generates a random sequence of blocks of two and four using the website www.Sealedenvelope.com. Based on this, participants are assigned to either the sumac group or the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The medications for both groups are packaged in vials of identical shape and size and then coded using a pre-generated table of random numbers; the researcher is unaware of the specific medication type.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Office of the Vice-Chancellor for Research, Asadabad Faculty of Medical Sciences
Street address
Asadabad, 22 Bahman Boulevard, former Amir-al-Mo'menin Hospital building, Department of Education.
City
asadabad
Province
Hamadan
Postal code
6541914438
Approval date
2026-01-01, 1404/10/11
Ethics committee reference number
IR.ASAUMS.REC.1405.012
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
N94.4
2
Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
N94.4
Primary outcomes
1
Description
Moderate to severe dysmenorrhea (VAS ≥ 4)
Timepoint
One and two months after the intervention, using the Visual Analog Scale (VAS) for pain.
Method of measurement
Visual analogue scale (VAS)
2
Description
Quality of Life
Timepoint
One and two months after the intervention
Method of measurement
SF-36 Quality of Life Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, 500 mg oral capsules containing dry sumac extract with a 30% yield (equivalent to 1 g of sumac) will be used. Students will be asked to take the capsules every 8 hours from the first to the seventh day across two consecutive menstrual cycles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Asadabad School of Medical Sciences
Full name of responsible person
azin niazi
Street address
Asadabad, 22 Bahman Boulevard, former Amir-ol-Momenin Hospital building.
City
asadabad
Province
Hamadan
Postal code
6541914438
Phone
+98 81 3313 2015
Email
azin_niazi65@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Asadabad University of Medical Sciences
Full name of responsible person
azin niazi
Street address
Asadabad, 22 Bahman Boulevard, former Amir-ol-Momenin Hospital building.
City
asadabad
Province
Hamadan
Postal code
6541914438
Phone
+98 81 3313 2015
Email
azin_niazi65@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Asadabad 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
Asadabad University of Medical Sciences
Full name of responsible person
azin niazi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Asadabad, 22 Bahman Boulevard, former Amir-al-Mu'minin Hospital building.
City
asadabad
Province
Hamadan
Postal code
6541914438
Phone
+98 81 3313 2015
Email
azin_niazi65@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Asadabad University of Medical Sciences
Full name of responsible person
azin niazi
Position
مربی
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Asadabad, 22 Bahman Boulevard, former Amir-al-Mu'minin Hospital building
City
asadabad
Province
Hamadan
Postal code
6541914438
Phone
+98 81 3313 2015
Email
azin_niazi65@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Asadabad University of Medical Sciences
Full name of responsible person
azin niazi
Position
مربی
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Asadabad, 22 Bahman Boulevard, former Amir-al-Mu'minin Hospital building.
City
asadabad
Province
Hamadan
Postal code
6541914438
Phone
+98 81 3313 2015
Email
azin_niazi65@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data are available upon contact with the corresponding author.
When the data will become available and for how long
One year after the article was published
To whom data/document is available
All faculty members of medical universities
Under which criteria data/document could be used
If they wish to conduct a more precise statistical analysis of the data, they should employ newer diagnostic methods to assess the study outcome.
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document