Comparison of the effect of commiphora mukul capsule with mefenamic acid on abnormal menstrual bleeding (menorrhagia)
Design
triple-blind clinical trial, randomized with R software, on 60 patients (two groups of 30)
Settings and conduct
Patients referred to the gynecological clinic of Afzalipour Hospital and health centers in Kerman, Iran, after confirmation of idiopathic menorrhagia by a gynecologist and performing the necessary tests, enter the study with informed consent. The capsules are in the same package and the doctor and the patient are not aware of its contents.
Participants/Inclusion and exclusion criteria
Login Criteria:
18 to 55 years old
idiopathic menorrhagia
Normal coagulation tests
Normal thyroid hormones
Normal Prolactin test
Normal ultrasound (absence of fibroma larger than 5 mm and other anatomical problems)
Negative pregnancy test
Signature informed consent
Exit Criteria:
Sensitivity to study drugs
Failure to follow the treatment method of the study
Reluctance to continue participating in the study
Intervention groups
Women aged 18 to 55 years with idiopathic menorrhagia living in Kerman, Iran
Main outcome variables
-Volume and number of bleeding days in women with idiopathic menorrhagia
-Hemoglobin levels in patients with menorrhagia
-Quality of life of patients with menorrhagia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211125053177N1
Registration date:2022-05-05, 1401/02/15
Registration timing:prospective
Last update:2022-05-05, 1401/02/15
Update count:0
Registration date
2022-05-05, 1401/02/15
Registrant information
Name
Asma Ahmadzadeh Heshmati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3253 2275
Email address
a.ahmadzade1388@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-11, 1401/04/20
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Commiphora mukul capsule and mefenamic acid on menorrhagia: A-triple-blind randomized clinical trial
Public title
Comparison of the effect of Commiphora mukul and mefenamic acid on abnormal mensural bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Menorrhagia
no history of known systemic or inflammatory pelvic diseases
not pregnant
Do not take certain medications
not having a Pap smear and abnormal ultrasound
not having a history of allergies to herbs
Exclusion criteria:
Age
From 15 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients to the two groups is done using the randomized block method in 4 blocks.
Random random block table for two groups using R software is prepared as follows:
B A
A A
A B
A A
B B
A A
B B
B B
B A
A B
B A
A A
B B
A B
B A
B B
A A
B B
A B
A B
A A
B A
A B
B A
A A
B B
B B
A B
A A
B A
Blinding (investigator's opinion)
Triple blinded
Blinding description
The capsule containing the Commiphora mukul extract will be very similar in appearance to the mefenamic acid capsule, the packaging of the drugs is the same and coded, and the way both drugs are used is the same. The patient, physician, and statistician do not know which drug each code belongs to
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
1355576169
Approval date
2022-03-08, 1400/12/17
Ethics committee reference number
IR.KMU.REC.1400.666
Health conditions studied
1
Description of health condition studied
menorrhagia
ICD-10 code
N92.0
ICD-10 code description
Excessive and frequent menstruation with regular cycle
Primary outcomes
1
Description
Menstrual bleeding volume and number of bleeding days based on Pictorial blood loss assessment chart (PBLAC)Hemoglobin level in CBC (Complete Blood Count) test
Timepoint
The seventh day of each cycle and if bleeding continues, the evaluation is done every week for up to three cycles
Method of measurement
Pictorial blood loss assessment chart (PBLAC), CBC (Complete Blood Count) laboratory test
Secondary outcomes
1
Description
Quality of Life
Timepoint
Beginning and end of the study (after the end of the third menstrual cycle)
Method of measurement
MQ Questionnaire
Intervention groups
1
Description
The first intervention group receives a 250 g capsule containing commiphora mukul powder every 8 hours every month from the first to the fifth day of menstrual bleeding for 3 consecutive months.
Category
Treatment - Drugs
2
Description
The second intervention group receives a 250 g capsule of mefenamic acid every 8 hours every month from the first to the fifth day of menstrual bleeding for 3 consecutive months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital clinic
Full name of responsible person
Asma Ahmadzadeh Heshmati
Street address
Unit One, Second Apartment on the left (Golshan Apartment), NO.8, Neshat Park
City
Kerman
Province
Kerman
Postal code
7613648443
Phone
+98 34 3253 2275
Email
a.ahmadzade1388@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Deputy of Research and Technology, Somayeh Crossroads (Tahmasb Abad) at the beginning of Ibn Sina Street
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Fax
+98 34 3226 3857
Email
VCR@KMU.AC.IR
Web page address
https://vresearch.kmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Asma Ahmadzadeh Heshmati
Position
PhD student in Iranian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Unit One, Second Apartment on the left (Golshan Apartment), NO.8, Neshat Park
City
Kerman
Province
Kerman
Postal code
7613648443
Phone
+98 34 3253 2275
Email
a.ahmadzade1388@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Asma Ahmadzadeh Heshmati
Position
PhD student in Iranian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Unit One, Second Apartment on the left (Golshan Apartment), NO.8, Neshat Park
City
Kerman
Province
Kerman
Postal code
7613648443
Phone
+98 34 3253 2275
Email
a.ahmadzade1388@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Asma Ahmadzadeh Heshmati
Position
PhD student in Iranian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Unit One, Second Apartment on the left (Golshan Apartment), NO.8, Neshat Park
City
Kerman
Province
Kerman
Postal code
7613648443
Phone
0098 34 2532275
Email
a.ahmadzade1388@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
Study data is published with confidentiality.
When the data will become available and for how long
After publishing the article
To whom data/document is available
The data is accessible to all researchers.
Under which criteria data/document could be used
The analyzed data can be used only by mentioning the source.
From where data/document is obtainable
scientific respondent of the study
What processes are involved for a request to access data/document
The study data can be received through the e-mail of the scientific respondent of the study