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Comparison the effectiveness of Plantain seeds and Tranexamic acid in the hemorrhage control of women with Menorrhagia

Protocol summary

Study aim
Determining the effectiveness of Plantain seeds and Tranexamic acid in the hemorrhage control of women with Menorrhagia
Design
In this research, 48 eligible patients with Menorrhagia referring to Ziaeian Hospital were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
After the explanation of the study for people referring to Ziaeian Hospital who have Inclusion criteria, all participants are given consent. At the start of these tests are taken: transvaginal ultrasonography, pap smear, CBC, hormonal tests include TSH, LH, FSH, as well as PT, PTT, INR, BUN, Cr, AST, ALT, and ALP. At the end of the study, CBC, PT, PTT, INR, BUN, Cr, AST, ALT, ALP are repeated for measurement of Hb changes and possible adverse drug reactions. The Pictorial Blood Loss Assessment Chart (PBAC) is used to measure bleeding in two cycles of treatment by the patient. Menorrhagia questionnaire (MQ) is used to measure the quality of life of patients. The pain assessment form is based on the VAS criteria in the two treatment cycles will be completed by the patient. Patients are randomly assigned to one of the groups. Medications are used in both groups for one week from menstruation and two menstruations.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of at least 18 years; Normal geneology examination; Normal pap smear; Endometrial thickness less than 12mm; Severe menstrual bleeding based on PBAC questionnaire Non-Inclusion criteria: significant medical problems; impairment of FSH and LH
Intervention groups
Boiled Plantain seeds 10 grams three times a day and half an hour after each meal in a glass of water; Tranexamic acid capsule 500 mg three times daily and half hour after each meal
Main outcome variables
The score of menstrual bleeding severity with Pictorial Bleeding Assessment Chart (PBAC)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160402027170N3
Registration date: 2017-12-31, 1396/10/10
Registration timing: registered_while_recruiting

Last update: 2017-12-31, 1396/10/10
Update count: 0
Registration date
2017-12-31, 1396/10/10
Registrant information
Name
Fatemeh Nejatbakhsh
Name of organization / entity
medical University Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 6675 4151
Email address
nejatbakhsh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tehran university School of Traditional Medicine
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness of Plantain seeds and Tranexamic acid in the hemorrhage control of women with Menorrhagia
Public title
Effectiveness of Plantain seeds in the Menorrhagia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of at least 18 years Normal gynecology examination Normal Pap Smear Endometrial thickness less than 12mm Severe menstrual bleeding based on PBAC questionnaire
Exclusion criteria:
Significant medical problems Impairment of FSH and LH
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation to treatment groups was conducted by an independent researcher using a random number sequence, generated with a computer-generated randomization scheme, according to a randomized block design. The block size was six. The randomization list was concealed from the primary researcher who enrolled and assessed participants in sequentially numbered, sealed, opaque envelopes
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, near Quds St., Keshavarz Ave. Tehran
City
Tehran
Province
Tehran
Postal code
1417733161
Approval date
2016-10-09, 1395/07/18
Ethics committee reference number
IR.TUMS.VCR.REC.1395.760

Health conditions studied

1

Description of health condition studied
Menorrhagia
ICD-10 code
N93
ICD-10 code description
Abnormal uterine and vaginal bleeding

Primary outcomes

1

Description
The score of menstrual bleeding severity with Pictorial Bleeding Assessment Chart (PBAC)
Timepoint
Before intervention, One month after the intervention began, two months after the intervention began
Method of measurement
Pictorial Bleeding Assessment Chart (PBAC)

Secondary outcomes

1

Description
The duration of menstrual bleeding
Timepoint
Before intervention, One month after the intervention began, two months after the intervention began
Method of measurement
Pictorial Bleeding Assessment Chart (PBAC)

Intervention groups

1

Description
Control group: Tranexamic acid capsule manufacturing of Razak company, 500 mg three times daily and half hour after each meal
Category
Treatment - Drugs

2

Description
Intervention group: boiled Plantain seeds 10 grams three times a day and half an hour after each meal in a glass of water
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Nejatbakhsh Fatemeh
Street address
Ziaeian Hospital, Abouzar St, District 17
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5573 8004
Email
Nejatbakhsh@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rahimi Roja
Street address
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8899 0837
Email
Rojarahimi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nejatbakhsh Fatemeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 0837
Fax
Email
Nejatbakhsh@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nejatbakhsh Fatemeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 0837
Fax
Email
Nejatbakhsh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nejatbakhsh Fatemeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 0837
Email
Nejatbakhsh@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Information about the main outcome after unidentifiable people can be shared
When the data will become available and for how long
Since print results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be used by Iranian and non-Iranian researchers in the field of medical sciences in order to perform IPD Meta-analysis and mentioning the name of the corresponding author of the original article in the colleagues of the secondary article. Other analyzes (other statistical models) are not acceptable and researchers are not allowed to use data to write initial studies
From where data/document is obtainable
Email the corresponding author of the article Nejatbakhsh@tums.ac.ir
What processes are involved for a request to access data/document
The requester sends a letter to the corresponding author of the article and sends a valid certificate of employment in academic and scientific institutions. The author responds within a maximum of 3 weeks and sends the data file
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