Protocol summary

Study aim
Determining and comparing the average of primary dysmenorrhea pain intensity in women receiving bromelain and placebo, before and after the intervention.
Design
A clinical trial with a control group, with parallel groups, triple-blind, randomized block
Settings and conduct
In this study, patients are randomly divided into two groups. The first group receives Anaheal GDU500 capsules (containing 200 mg bromelain GDU/g 2500), (GDU= Gelatin Digesting Unit) and the second group receives placebo. In order not to identify, both groups are prepared in uniform packaging and a unique code will be used on each. The reception of drug and placebo will be checked in two cycles and in these two cycles, they will receive every 8 hours for 3 days in the first three days of the menstrual cycle. The first month, non of the groups receive any medication, just answer questionnaires for baseline information. Medicines will be received for 2 months. Finally, the data will be collected at the end of each drug receiving day, with two questionnaires, Visual analogue Scale and Moos Menstrual Questionnaire, and will be analyzed with descriptive and analytical statistical methods by SPSS software.
Participants/Inclusion and exclusion criteria
Entry requirements: having a certain age range with a certain weight and regular and painful menstrual cycles Conditions of non-entry: having underlying and chronic diseases and sensitivity to herbal compounds, menstrual and abdominal-pelvic problems, using contraceptive pills, and having stress and mental problems
Intervention groups
The intervention group is 45 patients who take the Anaheal capsule three times a day for three days in two menstrual cycles. The control group is 45 patients who take the placebo capsule three times a day for three days in two menstrual cycles.
Main outcome variables
Investigating the effectiveness of bromelain extract on primary dysmenorrhea pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160813029327N23
Registration date: 2024-07-01, 1403/04/11
Registration timing: prospective

Last update: 2024-07-01, 1403/04/11
Update count: 0
Registration date
2024-07-01, 1403/04/11
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of bromelain and placebo on primary dysmenorrhea pain on female students
Public title
Investigating the effect of bromelain on primary dysmenorrhea pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being diagnosed with primary dysmenorrhea Age between 18-25 years old BMI between 19-25 Having the score of 5-8 in VAS Having regular menstrual cycles
Exclusion criteria:
Being diagnosed with secondary dysmenorrhea Using medications that might interact with NSAIDs Being on oral contraceptive pills Having allergy or sensitive reaction to herbal products of pineapple, carrot, celery and anise History of abdomen or pelvic surgery Contraindication of herbal drugs and NSAIDs (like having renal, hepatic or GI problems) Suffering from chronic illnesses such as diabetes, CKD, hepatic failure) Having sign and symptoms of itching, burning sensations and unnormal vaginal discharge Having pelvic inflammatory diseases Having tumor or fibrosis Having stress in the past 6 months Having endometriosis Patients with IUD Patients who started a specific regimen or vegetarian diet throughout the study Events happened that caused acute stress
Age
From 18 years old to 25 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly, a block of size six (with the help of CREATE A RANDOMISATION LIST computer program online tool) will be divided into two equal groups. In fact, 15 blocks of 6 people will be formed, and in each block, three people will be randomly assigned to the first group (bromelain) and three people to the second group (placebo).
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this three-blind randomized clinical trial study, patients receiving Anaheal or placebo are unaware of what drug they will receive. Also, the person (researcher) evaluating the severity and duration of the patients' pain will be unaware of what medicine each patient receives. The person analyzing the statistical data of the study will also be unaware of which group each patient belongs to.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad university of pharmaceutical sciences
Street address
No. 99, Yakhchal Ave., Gholhak, Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
19356466
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.IAU.PS.REC.1403.131

Health conditions studied

1

Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea

Primary outcomes

1

Description
Pain score of patients with primary dysmenorrhea
Timepoint
Before starting the intervention in the first cycle, then the second and third cycles each in the first 3 days
Method of measurement
VAS (Visual Analogue Scale)

Secondary outcomes

1

Description
Investigating various distressing states in patients with primary dysmenorrhea
Timepoint
Before starting the intervention in the first cycle, then the second and third cycles each in the first 3 days
Method of measurement
MMDQ= Moos Menstrual Distress Questionnaire

Intervention groups

1

Description
Intervention group: Receives Anaheal capsules GDU500 (containing 200 mg bromelain GDU/g 2500) producted by Salamat Parmoon Amin pharmaceutical company. Capsules will be given to patients to be used 3 times a day for the first 3 days of menstrual cycle, in 2 menstrual cycles.
Category
Treatment - Drugs

2

Description
Control group: Receives a placebo containing lactose producted by Salamat Parmoon Amin pharmaceutical company. Placebo capsules will be given to patients to be used 3 times a day for the first 3 days of menstrual cycle, in 2 menstrual cycles.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University of Pharmaceutical Sciences
Full name of responsible person
Parmida Sorahi
Street address
Yakhchal Ave., Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
parmidasorahi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Salamat Parmoon Amin pharmaceutical company
Full name of responsible person
Bayan Manoochehri
Street address
Number 10, West Nafisi street, South Sarrafha street, Darya Blv., Saadat Abad, Tehran
City
Tehran
Province
Tehran
Postal code
1998863174
Phone
+98 21 8837 7220
Email
dr.bayan@spameda.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Salamat Parmoon Amin pharmaceutical company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Afsaneh Ekhtiari
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Buali hospital, First of Damavand st., Imam Hussein square, Tehran
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
Afsanehekhtiari@gmail.com
Web page address
https://tms.iau.ir/bouali/fa/page/841/%D8%AF%DA%A9%D8%AA%D8%B1-%D8%A7%D9%81%D8%B3%D8%A7%D9%86%D9%87-%D8%A7%D8%AE%D8%AA%DB%8C%D8%A7%D8%B1%DB%8C

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Yakhchal Ave., Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
r_abrishami@iaups.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Parmida Sorahi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Yakhchal Ave., Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
parmidasorahi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this 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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