The aim of this study is the effectiveness sumac capsule on blood loss in women with menorrhagia. This study is randomized controlled clinical trial (block) in hospitals Hazrat Zeinab (SA) and martyr Faghihi. A total of 100 women with menorrhagia will be randomly divided into two groups. The risk of menorrhagia of diagram (PBAC) Pictorial Blood Loss Assessment Chart used to be participants receive a score of 100 and above. 50 patients will take Tranxamic acid capsules, 500 mg 3 times a day from the first day until the seventh day and 50 patients will take sumac capsule daily (1gram) in addition to the amount of acid Tranxamic acid capsules. At the beginning of the patient to the study of the CBC, PT, PTT and fibrinogen level and serum iron deficiency anemia measured to monitor. At the end of the cycle ,the patients will referre for PBAC chart delivery, testing and delivery of the drug for three cycles until the impact of sumac capsule on the amount of bleeding patients to be monitored. With Using PBAC charts scores of the two groups will be calculated and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041033352N1
Registration date:2017-06-08, 1396/03/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-08, 1396/03/18
Registrant information
Name
Nasrin Borazjanizadeh
Name of organization / entity
Shiraz University Of Medical Sciences, School Of Nursing And Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 71 3834 9889
Email address
stud1819664139@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research Shiraz University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Rhus Coriaria Capsul On Abnormal Uterin Bleeding (Menorrhagia) Referring To Selected Hospital
Public title
The Effect Of Rhus Coriaria On Abnormal Utrine Bleeding(Menorrhagia)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) willingness to cooperate 2) having 20-45 years of age, 3) getting to the doctor menorrhagia 4) lack of hemoglobin less than 10 5) no history of gastrointestinal and liver diseases, renal and cerebral thrombosis and history coagulopathies 6) lack of sensitivity to the metal and acid Tranksmyk 7) view of Bdny29-19 8) absence of polyps and fibroids 9) lack of uterine malignancies 10) using non-hormonal contraceptive IUD Wow 11) score of 100 the PBAC exclusion criteria: 1) lack of desire to continue participating in the study, 2) reduction of hemoglobin below 10 3) complications associated with treatment for the patient
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shiraz University of Medical Sciences
Street address
Department Of Research and Information Technology,shiraz university of medical science, Zand Bolvard.shiraz,iran
City
shiraz
Postal code
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.SUMS.REC.1395.200
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
Amount OF uterine bleeding
Timepoint
Before the intervention, one month after the intervention (at the end of the first menstrual cycle), second month, third month after menstruation and after menstruation cycle.
Method of measurement
Pictorial Blood Loss Assessment Chart
Secondary outcomes
1
Description
Anemia
Timepoint
Before the intervention, one month after the end of the cycle, the second month after the third month after menstruation and menstrual cycle
Method of measurement
PT.PTT.CBC,Fibrinogen Level،Serum Iron
Intervention groups
1
Description
The intervention group:the women will be received 1 gram of sumac capsules and Tranxamic acid capsule contain 500 mg, 3 times in a day, from the first day until the seventh menstrual cycle for 3 cycles.
Category
Treatment - Drugs
2
Description
Control group: the women in control group will be received Tranxamic acid capsule contain 500 mg, 3 times in a day, from the first day until the seventh cycle period for 3 cycles
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
zeynab hospital
Full name of responsible person
nasrin borazjanizadeh
Street address
Iran, Shiraz, Zand Street, nemazee square, School of Nursing and Midwifery, Shiraz
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research,shiraz university of medical science
Full name of responsible person
Dr.Seyed Basir Hashemi
Street address
vice chancellor for research, shiraz university of medical science,Zand Boulevard,Shiraz, Iran
City
shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research,shiraz university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery,Shiraz University of Medical Sciences,
Full name of responsible person
Masoumeh Kaviani
Position
Master of Science Midwifery
Other areas of specialty/work
Street address
Midwifrey Department,School of Nursing and Midwifery,Nemazee Square , Zand Blvd.Shiraz,Iran.
City
shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
kavianm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery,Shiraz University of Medical Sciences,Namazee Squere,Zand Blvd.Shira
Full name of responsible person
Masoumeh Kaviani
Position
Master of Science Midwifery
Other areas of specialty/work
Street address
Midwifery Department,School of Nursing and Midwifery,Nemazee Square,Zand Blvd.Shiraz,Iran
City
shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
kavianm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Masoumeh Kaviani
Position
Master of Science Midwifery / Midwifery Group Manager
Other areas of specialty/work
Street address
Midwifery Department,School of Nursing and Midwifery,Nemazee Square ,Zand Blvd.Shiraz,Iran
City
Shiraz
Postal code
Phone
+98 71336474254
Fax
Email
kavianm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)