The effect of plantago major suppository on the volume of menstrual bleeding in patients with uterine lyomium
Design
A randomized clinical trial study was conducted in a control group with parallel and bilingual blind groups. The sample size was 60. They were divided into two groups A and B, using the Randomization Block method, which were divided into Group A is given a drug and Group B is given a placeb.
Settings and conduct
In this method a group of patients Mefenamic acid capsule every 8 hours, one_ hour plus vaginal suppository, every 8 hours, one day and another group of mefenamic acid, every
8 hours one day plus placebo suppository, every 8 hours, one
vaginal number in the first three days of menstruation that
have a large amounts of bleeding, receives them .
Research location: Obstetrics and Gynecology, Supra clinic
touba, Sari City.
Participants/Inclusion and exclusion criteria
-Inclusion criteria:
-Being 18 to 50 years old
-Having ultrasonography of submucosal uterine lyomium with uterine bleeding
Exite criteria:
- Women with Surgical indication
-Fast increase in mass size after menopause
-positive pregnancy test
-Known severe coagulation disease
-Hb under 9/5
Intervention groups
Intervention group: Vaginal suppositories of plantago leaf extract is prescribed in the first three days of menstruation in two consecutive months
Control group:All the components of the intervention group suppository except plantago leaf extract
Main outcome variables
Blood volume
General information
Reason for update
Acronym
اثر بارهنگ بر خونریزی قاعدگی
IRCT registration information
IRCT registration number:IRCT20181001041191N1
Registration date:2019-02-22, 1397/12/03
Registration timing:registered_while_recruiting
Last update:2019-02-22, 1397/12/03
Update count:0
Registration date
2019-02-22, 1397/12/03
Registrant information
Name
fatemeh navaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 4893
Email address
f.navaei@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of suppository plantago leaf extract on quantity of menstural bleeding in patients with uterine leiomyoma
Public title
Effect of plantago major in menstrual bleeding in patients with uterine leiomyoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having an age 18- 50 BMI 18/5- 29/9
Regular menstrual cycle
Being married
submucosal leiomyoma in ultrasonography with menstrual bleeding
Unwillingness Or contraindication to taking hormone
Exclusion criteria:
Surgical indication
Unusal bleeding
Anemia resistant to usual treatments
Dysmenorrhea or severe dyspnea
Acute pain Symptoms of severe urination or hydronephrosis
Fast increase in mass size
Start of tumor growth after menopause
Patients with gastrointestinal complications Patients treated with progesterone Patients treated with acetylsalicylic acid Patient treated with anti - coagulan Patient treated with tranexamic Acid AND Ocp Taking miphe priston ' aganists NSAID' Gnrh
Woman have positive pregnancy test
Known hemoglobinopathy Known severe coagulation disease anti-fibrinolytic or systemic glucocorticoids
Hb under 9/5
Pap smear due to displasticity disorders
Having IUD
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients referring to women's clinic that are based on examinations criteria
They will be admitted to the study and the diagnosis of their uterine leiomyoma will be included in the study. 60 samples will be assigned by blocking method to two groups. The sample allocation method will be performed using the software, and the samples will be assigned in four blocks,
Random numbers are for blocks through the software.
Patients will be placed in two groups A and B using the Randomization Block.
Group A is given drug and given to Group B placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
For double - blind blonding, medications are prepared in
special envelops with the installation of two - digit codes
until the final evaluator who is a gynecologist is not aware
of the type of medication received. also, for lack of information to the patient The drug received by preparing
a placebo in Sari Pharmacy School that It looks be looks
like a plantago major suppository that for the control group will be considered and the patients will not be aware of the
type of drug they receive.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Teacher Street, Teacher's Square
City
Sari
Province
Mazandaran
Postal code
48168-95474
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.MAZUMS.REC.1397.157
Health conditions studied
1
Description of health condition studied
Submucous leiomyoma of uterus
ICD-10 code
D25.0
ICD-10 code description
Submucous leiomyoma of uterus
Primary outcomes
1
Description
volume of bleeding menstruation
Timepoint
The first three days of menstruation in two consecutive months
Method of measurement
Standard Bleeding Reporting Form PBAC
Secondary outcomes
1
Description
Blood volum
Timepoint
The first three days of the menstrual cycle
Method of measurement
PBAC questionnaire
Intervention groups
1
Description
Intervention group: A total of 30 patients were treated with vaginal suppository of plantago leaf extract in two consecutive months during the first three days of menstruation
Category
Treatment - Drugs
2
Description
Control group: 30 patients with hemorrhagic fibroma receiving the suppository containing all the components of the intervention group formulation, except for plantago leaf extract.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Touba clinic
Full name of responsible person
Syedeh Sedigheh Yousefi
Street address
Touba Clinic; Khazar Boulevard; Khazar Square
City
sary
Province
Mazandaran
Postal code
48168-95474
Phone
+98 11 3324 4893
Fax
+98 11 3324 4893
Email
f.navaei@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Teacher Street, Teacher's Square
City
Sari
Province
Mazandaran
Postal code
48168-95474
Phone
+98 11 3325 7230
Email
m.saeedi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Syedeh Sedigheh Yousefi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari
City
sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Fax
+98 11 3324 4894
Email
s.yousefi@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Syedeh Sedigheh Yousefi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Fax
+98 11 3324 4894
Email
s.yousefi@mazums.ac.i
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Navaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Fax
+98 11 3324 4894
Email
F.navaei@mazums.ac.ir
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