Protocol summary

Summary
The aim of this triple-blind randomized controlled trial with two parallel arms is to determine the effect of ethanol extract of Iranian borage (Echium amoenum) on pain intensity and quality of life enjoyment and satisfaction (primary outcomes) and menstrual bleeding (secondary outcome). Visual analogue scale, quality of life enjoyment and satisfaction questionnaire and Higham chart will be used to assess the outcomes, respectively. After signing an informed consent, all selected eligible students with moderate to severe primary dysmenorrhea living in Tabriz student dormitories will be asked to take identical analgesic (gelofen capsules) for menstrual pain relief, if needed. They will be asked to record their menstrual pain, number of analgesics used, the quality of life and menstrual blood loss in the following cycle (running period). 70 of them, who had good cooperation, will be allocated into two groups using block randomization with block size of 4 and 6 and allocation ratio of 1:1, stratified by dormitory. Consecutive numbered packs, each containing 18 identical capsules of 500 mg Echium amoenum or placebo will be used for the blinding. Each participant will get one of the packs in their recruitment rank, to use the capsules every 12 hours since onset of menstrual pain for 72 hours or until the pain relief, for three following cycles. They will be asked to record the capsule use and any side effects on a diary, in addition to recording menstrual pain, number of the gelofen used, the quality of life and menstrual blood loss, in the three cycles.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201601143706N28
Registration date: 2016-02-29, 1394/12/10
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-02-29, 1394/12/10
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-03-07, 1394/12/17
Expected recruitment end date
2016-05-15, 1395/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ethanol extract of Iranian borage (Echium amoenum) on pain intensity and quality of life enjoyment and satisfaction of students with primary dysmenorrhea: a randomized controlled trial
Public title
The effect of ethanol extract of Iranian borage on menstrual pain intensity and quality of life enjoyment and satisfaction of students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) single; 2) age between 18 and 30 years; 3) regular menstrual periods with interval of 21 to 35 days; 4) moderate to severe menstrual pain (above 4.4 mm in 10 cm VAS) over the past 6 months; 5) lack of heavy menstrual bleeding Exclusion criteria: 1) any sensitivity to herbal medicines; 2) smoking or alcohol drinking; 3) any known chronic diseases; 4) no easy access to telephone line for the follow-ups
Age
From 18 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research Deputy, 3rd Floor, Centeral Building No 2 , Tabriz University of Medical Sciences, Golgasht st., Tabriz
City
Tabriz
Postal code
Approval date
2016-01-04, 1394/10/14
Ethics committee reference number
TBZMED.REC.1394.881

Health conditions studied

1

Description of health condition studied
primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
primary dysmenorrhea

Primary outcomes

1

Description
Quality of Life Enjoyment and Satisfaction
Timepoint
1) one cycle before intervention 2) The third cycle after intervention
Method of measurement
Quality of Life Enjoyment and Satisfaction questionnaire

2

Description
Number of Gelofen used
Timepoint
1) one cycle before intervention 2) The first , second and third cycles after intervention
Method of measurement
Visual analogue scale (VAS) for pain

3

Description
Menstural pain intensity
Timepoint
1) one cycle before intervention 2) The first, second and third cycles after intervention
Method of measurement
Visual Analog scale ((VAS٬0-10)

Secondary outcomes

1

Description
Menstural Symptom Severity
Timepoint
1) one cycle before intervention 2) The first cycle, the second and third after intervention
Method of measurement
Symptom Severity Scale

2

Description
Menstrual blood loss
Timepoint
1) one cycle before intervention 2) The first cycle, second and third cycles after intervention
Method of measurement
Chart Higham

3

Description
Side effects
Timepoint
The first cycle, the second and third after intervention
Method of measurement
Self report on a diary

4

Description
Satisfaction with treatment
Timepoint
The first cycle, the second and third after intervention
Method of measurement
self report- one likert question

Intervention groups

1

Description
Intervention group: taking capsules containing 500 mg Iranian borage (Echium amoenum) every 12 hours, from onset of menstrual pain for 72 hours or until the pain relief for three consecutive cycles
Category
Treatment - Drugs

2

Description
Control group: taking placebo capsules every 12 hours, from onset of menstrual pain for 72 hours or until the pain relief for three consecutive cycles
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Student dormitories at Tabriz
Full name of responsible person
Farideh quick
Street address
South Shariati, Kosar dormitory
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad-Reza Rashidi
Street address
Research Deputy, 3rd floor, Centeral building No 2, Tabriz University of Medical Sciences, Golgasht st., Tabriz
City
Tabriz
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, Tabriz 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
Midwifery Department, Nursing & Midwifery Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Farideh Quick
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
City
Tabriz
Postal code
Phone
+98 87 3552 2646
Fax
Email
Faridequick@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
PhD in Reproductive Health, Associate Professor
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street, Tabriz, Postal Code 5138947977, PO Box 347-51745
City
Tabriz
Postal code
5138947977
Phone
+98 41 3477 2699
Fax
Email
alizades@tbzmed.ac.ir; mhammadalizadehs@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Midwifery Department, Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street, Tabriz
City
Tabriz
Postal code
5138947977
Phone
+98 41 3477 2699
Fax
+98 41 1479 6969
Email
alizades@tbzmed.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
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