Protocol summary

Summary
This study aimed to compare the effectiveness of ginger and frankincense on menstrual bleeding volume. This study is a randomized, double blind, multi-center clinical trial with placebo control. Inclusion criteria: Outpatient women at the age of 18-45 years with regular 22 to 35-day menstrual cycles suffering from heavy or prolonged menstrual bleeding; normal endometrial thickness in ultrasound; normal gynecologic examination; normal Pap smear; absence of moderate or severe anemia; not using hormonal drugs or any medication affecting menstrual bleeding (oral contraceptive pills and aspirin, warfarin). Exclusion criteria: severe bleeding which requires emergency measures; extreme skin sensitivity to frankincense or ginger. Intervention group 1: Frankincense capsule and ibuprofen tablet will be prescribed for the patients, three times a day, from first to the last day of menstrual period. This order will be followed in two consecutive cycles. Intervention group 2: Ginger capsule and ibuprofen tablet will be prescribed for the patients, three times a day, from first to the last day of menstrual period. This order will be followed in two consecutive cycles. Control group: Placebo capsule and ibuprofen tablet will be prescribed for the patients, three times a day, from first to the last day of menstrual period. This order will be followed in two consecutive cycles. Primary outcomes: the duration and severity of bleeding of menstrual periods.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062228579N1
Registration date: 2017-02-03, 1395/11/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-02-03, 1395/11/15
Registrant information
Name
Razieh Eshaghian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2512
Email address
r_eshaghian@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison between frankincense (Boswellia serrata) capsule and ginger (Zingiber officinale) capsule on reducing heavy menstrual bleeding among women at the age of 18-45 years
Public title
Ginger capsule and frankincense effect on uterine hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Outpatient women at the age of 18-45years; Regular 22- 35 day menstrual cycles; presence of menorrhagia based on Higham bleeding assessment chart (bleeding more than 80 ml per cycle, or more than 7 days); absence of moderate or severe anemia (hemoglobin greater than 10.5 milligrams per deciliter); The absence of uterine fibroma or being smaller than 5 cm; The absence of ovarian cysts; Not using hormonal drugs or any medication affecting menstrual bleeding (oral contraceptive pills and aspirin, warfarin); normal endometrial thickness in abdominal or trans vaginal ultrasound; The patient is not pregnant or during lactation. Exclusion criteria: pregnancy; breast feeding; taking hormonal drugs or mefenamic acid during their menstruation period; being allergic to ginger or frankincense; severe bleeding during menstruation period requiring emergency measures.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study is a randomized, double-blind clinical trial (randomized block design permutations with blocks on volume 3)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Isfahan University of Medical Sciencesl
Street address
Isfahan University of Medical Sciences, Hezar jarib street, Azadi square
City
Isfahan
Postal code
Approval date
2016-08-17, 1395/05/27
Ethics committee reference number
IR.MUI.REC.1395.30414

Health conditions studied

1

Description of health condition studied
Heavy menstrual bleeding
ICD-10 code
N92.0
ICD-10 code description
Excessive and frequent menstruation with regular cycle

Primary outcomes

1

Description
Menstrual blood volume
Timepoint
The end of each menstrual cycle
Method of measurement
Pictorial Blood Loss Assessment (PBAC)

2

Description
Time period (days) of menstrual bleeding
Timepoint
The end of each menstrual cycle
Method of measurement
Pictorial Blood Loss Assessment (PBAC)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Frankincense capsule and ibuprofen tablet will be prescribed for the patients, three times a day, from first to the last day of menstrual period. This order will be followed in two consecutive cycles.
Category
Treatment - Drugs

2

Description
Intervention group 2: Ginger capsule and ibuprofen tablet will be prescribed for the patients, three times a day, from first to the last day of menstrual period. This order will be followed in two consecutive cycles.
Category
Treatment - Drugs

3

Description
Control group: Placebo capsule and ibuprofen tablet will be prescribed for the patients, three times a day, from first to the last day of menstrual period. This order will be followed in two consecutive cycles.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al Zahra Hospital's gynecology clinic
Full name of responsible person
Razieh Eshaghian
Street address
Soffeh Boulevard
City
Isfahan

2

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital's gynecology clinic
Full name of responsible person
Razieh Eshaghian
Street address
Felezzi bridge, Shahid Motahari street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chacellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Mazaheri
Street address
Traditional Medicine Department, Isfahan University of Medical Sciencesedical Science, Hezarjarib street
City
Isfahan
Grant name
Grant code / Reference number
395414
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chacellor for research, Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Razieh Eshaghian
Position
PHD student of TraditionalL Medicine
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jarib street, Azadi square
City
Isfahan
Postal code
Phone
+98 31 3376 7525
Fax
Email
r_eshaghian@resident.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Mazaheri
Position
PhD, Assistance professor of Traditional Medicine
Other areas of specialty/work
Street address
Traditional Medicine Department, Isfahan University of Medical Sciencesedical Science
City
Isfahan
Postal code
Phone
+98 31 3792 8108
Fax
Email
mazaherimohammad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Razieh Eshaghian
Position
PhD student of Traditional Medicine
Other areas of specialty/work
Street address
Traditional medicine group, Isfahan University of Medical Science,Hezarjarib street
City
Isfahan
Postal code
Phone
+98 31 3792 8108
Fax
Email
r_eshaghian@resident.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...