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Compare the effects of Teucrium Polium L and Ginger capsules in reducing menstrual pain in the students of Malayer Nursing College

Protocol summary

Study aim
Comparing the effects of Teucrium Polium L and Ginger capsules in reducing menstrual pain in Malayer Nursing School students
Design
A clinical trial with two intervention groups with Teucrium Polium and ginger capsules will be conducted randomly on 70 people
Settings and conduct
This study will be conducted on students of Malayer School of Medical Sciences.
Participants/Inclusion and exclusion criteria
Entry requirements: Single, age 18- 25 years, regular menstrual cycle 21-35 days, moderate to severe pain according to McGill's scale, no history of abdominal and pelvic surgery, no symptoms such as burning, itching, and abnormal discharge, no heart, kidney, or liver disease, pyloric stenosis, diabetes, high blood lipids, and no stress factors such as death of first-degree relatives, separation from parents, or others within the last 6 months. Exclusion criteria: Allergy to Ginger, allergy to Teucrium Polium L, unwillingness to continue cooperation
Intervention groups
The intervention group consists of two groups of 35 people (total 70) who consume Teucrium Polium and ginger capsules during two consecutive cycles. The samples of both groups should consume one capsule every 6 hours during the first three days of their cycle.
Main outcome variables
Improvement of menstrual pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250311065045N1
Registration date: 2025-04-18, 1404/01/29
Registration timing: prospective

Last update: 2025-04-18, 1404/01/29
Update count: 0
Registration date
2025-04-18, 1404/01/29
Registrant information
Name
Mahsa Fadakar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3224 1307
Email address
mahsa.fadakar94@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-04-21, 1404/02/01
Expected recruitment end date
2025-06-25, 1404/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effects of Teucrium Polium L and Ginger capsules in reducing menstrual pain in the students of Malayer Nursing College
Public title
ompare the effects of Teucrium Polium L and Ginger capsules in reducing menstrual pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
single Age 18-25 Regular menstrual cycle 21-35 days Moderate and severe pain intensity experience according to the McGill scale No history of abdominal and pelvic surgery No symptoms such as burning, itching, or abnormal discharge No heart, kidney, liver disease, pyloric stenosis, diabetes, or high blood lipids no stressful factors such as death of first-degree relatives, separation from parents, etc. within the last 6 months.
Exclusion criteria:
Allergy to Ginger Allergy to Teucrium Polium L Unwillingness to continue cooperation
Age
From 18 years old to 25 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
First, purposive sampling is carried out in a larger number than the desired sample size among the eligible girls residing in the dormitory. After introducing himself, the researcher will explain the objectives and method of conducting the research to the participants. Then, 70 students with the study entry criteria who have primary dysmenorrihea are placed in separate blocks (moderate and severe dysmenorrihea). In the next stage, people with moderate and severe pain intensity are divided into two groups of "Ginger and Teurium Polium L" capsules in equal numbers and randomly assigned using Excel software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Hamadan University of Medical Scieneces
Street address
Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2025-03-01, 1403/12/11
Ethics committee reference number
IR.UMSHA.REC.1403.893

Health conditions studied

1

Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.6
ICD-10 code description
Dysmenorrhea, unspecified

Primary outcomes

1

Description
Percentage of people with dysmenorrhea
Timepoint
Measuring the amount of menstrual pain at the beginning of the menstrual cycle and its continuation for three days and in two consecutive cycles
Method of measurement
McGill Pain Ruler

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The group receiving 250 mg of Teucrium Polium during the first three days of each cycle (every 6 hours) and receiving this capsule for 2 consecutive cycles
Category
Treatment - Drugs

2

Description
Intervention group: The group receiving 250 mg ginger capsules during the first three days of each cycle (every 6 hours) and receiving these capsules for 2 consecutive cycles
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Malayer University of Medical science
Full name of responsible person
Mahsa Fadakar
Street address
Malayer University of Medical science, Nabovat Blvd
City
Malayer
Province
Hamadan
Postal code
6571864953
Phone
+98 81 3335 2226
Email
mahsa.fadakar94@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Vice President for Research and Technology, Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
mahsa fadakar
Position
Faculty of Malayer Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Malayer University of Medical Science, Nabovat Blvd
City
Malayer
Province
Hamadan
Postal code
6571864953
Phone
+98 81 3335 2226
Email
mahsa.fadakar94@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahsa Fadakar
Position
Faculty of Malayer Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
malayer university of medical science, Nabovat Blvd
City
Malayer
Province
Hamadan
Postal code
6571864953
Phone
+98 81 3335 2226
Email
mahsa.fadakar94@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahsa Fadakar
Position
Faculty of Malayer Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
malayer university of medical science, Nabovat Blvd
City
Malayer
Province
Hamadan
Postal code
6571864953
Phone
+98 81 3335 2226
Email
mahsa.fadakar94@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
I will share all demographic and obstetric information of participants.
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
Researchers working in scientific and academic institutions
Under which criteria data/document could be used
Conducting similar research Using study results for future prevention and treatment studies
From where data/document is obtainable
Receive documents via email
What processes are involved for a request to access data/document
The applicant should first send an email to the first author. The author will respond via email within 1-2 weeks.
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