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Effect of willow bark on primary dysmenorrhea in female students

Protocol summary

Study aim
compare the Effect of Mefenamic Acid and willow bark in the of Dysmenorrhea among students.
Design
The study was Randominization, double-blind, active control, cross-over trial. Study was 2-sequence crossover design over consecutive menstrual cycles (two treatment periods) .
Settings and conduct
This study was a double-blind cross-over randomized clinical trial that was performed on 275 Students In the nearest dormitory of the Shahrekord University of Medical Sciences over 6 months .
Participants/Inclusion and exclusion criteria
Inclusion criteria :being single, suffering from level two or three primary dysmenorrhea , absence of any genital organs diseases , having no systemic diseases ,surgery during the past 8 weeks; ,hormonal therapy during the last 6 months and hypersensitivity to aspirin , having regular menstrual cycles, using no contraceptives. ٍٍExclusion criteria: non-responsive menstrual pain to NSAID in the past, history of hypersensitivity to NSAIDs
Intervention groups
During the first two cycles, the severity of dysmenorrhea was measured Students were randomly allocated into either treatment using randomized block design in the two next consecutive cycles. In cycle 3, group A received willow bark capsule as the intervention and group B received mefenamic acid capsule as the active control. In cycle 4, patients in group A received mefenamic acid capsule and group B patients received willow bark capsule
Main outcome variables
The pain level experienced by the students was assessed by visual analog scale . The secondary outcome measures are the menstrual symptom scale. Pictorial blood assessment chart, The bleeding amount was measured using chart

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180123038486N1
Registration date: 2018-11-01, 1397/08/10
Registration timing: retrospective

Last update: 2018-11-01, 1397/08/10
Update count: 0
Registration date
2018-11-01, 1397/08/10
Registrant information
Name
Ziba Raisi Dehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3224 0556
Email address
ziba758@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-01-10, 1393/10/20
Expected recruitment end date
2016-01-30, 1394/11/10
Actual recruitment start date
2015-05-10, 1394/02/20
Actual recruitment end date
2016-02-09, 1394/11/20
Trial completion date
2017-12-10, 1396/09/19
Scientific title
Effect of willow bark on primary dysmenorrhea in female students
Public title
willow bark and dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
suffering from level two or three primary dysmenorrhea according to the Andersch and Milsom’s verbal multi-dimensional scoring system aged 18 to 28 years old regular menstrual cycles without history of allergy to willow bark single students
Exclusion criteria:
absence of any genital organs diseases history of hypersensitivity to NSAIDs systemic diseases neurologic or psychiatric disease surgery during the past eight weeks hormonal therapy during the last six months used contraceptives
Age
From 18 years old to 28 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 110
Actual sample size reached: 98
Randomization (investigator's opinion)
Randomized
Randomization description
Students were randomly allocated into either treatment using randomized block design in the two next consecutive cycles
Blinding (investigator's opinion)
Triple blinded
Blinding description
The capsules of Willow bark extract were produced with the same appearance, color and odor as Mefenamic acid capsules.
Placebo
Used
Assignment
Crossover
Other design features
No

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Shahrekord University of Medical Sciences
Street address
Deputy for Research, second Floor, the central structure of shahrekord University of Medical Sciences
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817846935
Approval date
2013-01-08, 1391/10/19
Ethics committee reference number
91-10-23

Health conditions studied

1

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

Primary outcomes

1

Description
pain level
Timepoint
Before intervention and After Intervention
Method of measurement
visual analog scale (VAS).

2

Description
menstrual symptoms
Timepoint
Before intervention and After Intervention
Method of measurement
COX menstrual symptom scale

3

Description
bleeding amount
Timepoint
Before intervention and After Intervention
Method of measurement
Pictorial blood assessment chart

Secondary outcomes

1

Description
Safety and adverse event
Timepoint
After intervention
Method of measurement
case-report form.

Intervention groups

1

Description
Intervention group:received willow bark extract capsule (240 mg salicin ) with Placebo three times daily, produced by Medical Plants Research Center, Basic Health Sciences Institute, Shahrekord University of Medical Sciences, Shahrekord, Iran. The treatments were administered to the students for 1 h after experiencing dysmenorrhea until pain relief, for 4 cycles.
Category
Treatment - Drugs

2

Description
Control group: control group: received Mefenamic acid capsule 250mg, three times daily,produced by Razak pharmaceutical company of Iran , 1 h after experiencing dysmenorrhea until pain relief, for 4 cycles.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
dormitory of the Shahrekord University of Medical Sciences
Full name of responsible person
Ziba Raisi Dehkordi
Street address
Rahmateye.dormitory of the Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817846935
Phone
+98 38 3224 0556
Email
ziba758@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ziba Raisi Dehkordi
Street address
Number 4, Melat Avenue, Shahrekord Univercity of Medical Sciences
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817846935
Phone
+98 38 3224 0556
Email
ziba758@gmail.com
Grant name
12
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Ziba Raisi Dehkordi
Position
Master of Science in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Number 4, Kashani Avenue, Shahrekord Univercity of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817846935
Phone
+98 38 3224 0556
Email
ziba758@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ziba Raisi Dehkordi
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Number 4, kashani Avenue, Shahrekord Univercity of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817846935
Phone
+98 38 3224 0556
Email
ziba758@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ziba Raisi Dehkordi
Position
Master of nursing
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Number 4, Melat Avenue, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817846935
Phone
+98 38 3224 0556
Email
ziba758@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
Not applicable
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