Protocol summary

Study aim
The aim of this study was to compare the effect of traditional Anjebar booali daroo medicine and Mefenamic acid on abnormal uterine bleeding in women with high vaginal bleeding and age range of 20 to 45 years.
Design
Clinical trial with drug and control group with parallel and randomized triple blind groups
Settings and conduct
In this study, patients who referred to Izadi hospital due to vaginal bleeding were included. Patients enter the study after entering the study, clinical examination and interview with a specialist physician. In this study, patients will randomly receive a Anjebar booali daroo syrup with placebo capsule, and the other group will receive a mefenamic acid capsule each month with a placebo syrup. Treatment duration is 3 menstrual cycles and severity of bleeding, quality of life and pain will be measured at the end of each cycle.A randomized, controlled, triple-blind clinical trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient satisfaction, bleeding more than 7 days or periods less than 21 days, Married women, Ages 20 -45 years, The Pap smear is normal, Blood tests is normal, Endometrial thickness in ultrasound is normal. Exclusion criteria:Hormone Therapy Pregnancy and lactation, diabetes, kidney disease, coagulants and cancers Hypothyroidism and hyperthyroidism, Sub-mucosal or intramural fibroids larger than 5 cm, Active gastrointestinal bleeding, Hemophilia
Intervention groups
Anjebar booali daroo syrup and placebo syrup. ake 15 ml every eight hour and Placebo capsule 250mg( pharmaceutical company Booali Daroo)Take one capsule every eight hour.Control:Placebo syrup(pharmaceutical company Booali Daroo).Take 15 ml every eight hour and Mefenamic acid capsule 250mg( pharmaceutical company Amin) Take one capsule every eight hour In three consecutive menstrual cycles.
Main outcome variables
severity of bleeding , quality of life and pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200113046110N1
Registration date: 2020-02-15, 1398/11/26
Registration timing: prospective

Last update: 2020-02-15, 1398/11/26
Update count: 0
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
Zahra Yazdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3770 6470
Email address
y313.zahra@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Anjebar Syrup and Mefenamic Acid on Abnormal Uterine Bleeding
Public title
Comparison of Anjebar syrup and Mefenamic Acid on Abnormal Uterine Bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction Bleeding more than 7 days or periods less than 21 days Married women Patients 20 to 45 years Normal pap smear test Normal blood tests Normal endometrial thickness
Exclusion criteria:
Hormone therapy Pregnancy and lactation Diabetes Kidney disease Coagulants and cancers Hypothyroidism and hyperthyroidism Sub-mucosal or intramural fibroids larger than 5 cm, Active gastrointestinal bleeding Hemophilia
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The way to select groups is that they will be assigned to groups based on block randomization. Blocks of size 4 are considered. So we will have six blocks containing AABB, ABAB, BBAA, BABA, ABBA, BAAB. Each block will also be randomly selected using a dice throw. For example, if thrown dice is 3, the BBAA block is considered, and therefore the first two patients are assigned to treatment B and the next two patients to treatment A. The dice will be thrown 20 times to complete the assignment of patients to the treatment groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Anjebar syrup and placebo syrup are introduced into uniform, colorless pets and the color of the two syrups are matched using the authorized pharmaceutical colors. Mefenamic acid capsules and placebo capsules are also packaged in identical shells and packaged in flacons containing 70 capsules. Each drug is then recorded on the same basis as drug name, batch number, proprietary drug use, drug use, and period of use. The two drugs are packaged in the same form.The differentiation of each drug is a number extracted from the randomization list and provided to the executor as codes A and B.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
No. 83, No. 4 Alley, 1/1 Alley, Saffashahr street
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2019-11-05, 1398/08/14
Ethics committee reference number
IR.MUQ.REC.1398.101

Health conditions studied

1

Description of health condition studied
Abnormal Uterine Bleeding
ICD-10 code
N93
ICD-10 code description
Abnormal Uterine and Vaginal Bleeding

Primary outcomes

1

Description
Intensity of menstrual bleeding
Timepoint
At the end of each cycle
Method of measurement
Hygam chart

2

Description
Pain
Timepoint
At the end of each cycle
Method of measurement
Questionnaire visual analog scale

3

Description
Menstrual period duration
Timepoint
At the end of each cycle
Method of measurement
Menorrhagia questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Anjebar booali daroo syrup and placebo syrup ( pharmaceutical company Booali Daroo). Take 15 ml every eight hour and Placebo capsule 250mg( pharmaceutical company Booali Daroo) Take one capsule every eight hour In three consecutive menstrual cycles by 21 days
Category
Treatment - Drugs

2

Description
Control group: Placebo syrup ( pharmaceutical company Booali Daroo). Take 15 ml every eight hour and Mefenamic acid capsule 250mg( pharmaceutical company Amin) Take one capsule every eight hour In three consecutive menstrual cycles by 21 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Izadi hospital
Full name of responsible person
Zahra Yazdi
Street address
Shahid Del Azar street,Izadi hospital
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2058
Email
y313.zahra@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zahra Yazdi
Street address
Medical Sciences University of Qom,Shahid Lavasani St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 6470
Fax
Email
arbageri11@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
BooaliDaroo 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
Ghoum University of Medical Sciences
Full name of responsible person
Zahra Yazdi
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Lavasani St. Medical Sciences University of Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 6470
Fax
Email
y313.zahra@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zahra Yazdi
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Lavasani St. Medical Sciences University of Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 6470
Fax
Email
y313.zahra@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Zahra Yazdi
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Lavasani St. Medical Sciences University of Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 6470
Fax
Email
y313.zahra@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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