Protocol summary

Summary
The aim of this study was to investigate the effect of ginger and passion flower on the pain of patients with primary dysmenorrhea. Design: Randomized, one blind clinical trial, one-stage trial .study population: Girls with primary dysmenorrhea referring to Khomein health centers after examination by The gynecologist . The main criteria for entering the study are those with moderate and severe dysmenorrhea, single girls aged between 18 and 30 years, with regular menstrual cycles. The main outcomes of the study included contraceptive pills, herbal and allergy susceptibility, this study included 120 females with primary dysmenorrhea, selected by simple sampling and randomly assigned into three groups of 40, The randomization was performed in three groups (intervention group 1 and 2, and control group). In the intervention group 1 ginger capsule (500 mg ginger root powder), Golgardo Company manufactured in Iran and under the brand name Zinetuma three times a day at the beginning of the menstrual cycle for three days and in intervention group 2, drop of passion flower Brandy (Pas pp) brand made by Iran Daruk Company (20 drops in the morning, 40 drops in the evening) and in the third group (control group) one of the common treatments for the primary dysmenorrhea, ie mefenamic acid (250mg) The ponstan brand of Razak Company is given 4 times every 6 hours for 2 months (monthly cycle). Intervention Time: Month (Monthly Cycle) Initial Outcome: Dysmenorrhea is the amount of pain at the beginning and end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201707083227N10
Registration date: 2017-08-19, 1396/05/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-19, 1396/05/28
Registrant information
Name
Ashraf Salehi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 5222 7550
Email address
salehi.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor Of Research And Research Of Arak University Of Medical Sciences
Expected recruitment start date
2017-07-18, 1396/04/27
Expected recruitment end date
2018-02-16, 1396/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ginger and passion flower On pain in patients with primary dysmenorrhea
Public title
Effect of ginger and passion flower On pain in patients with primary dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
The main criteria for entering the study are those with moderate and severe dysmenorrhea, single girls aged between 18 and 30 years, with regular menstrual cycles. The main outcomes of the study included the use of contraceptive pills, drug and herbal susceptibility
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Arak University Of Medical Sciences
Street address
University Of Khomein Medical Sciences
City
Khomein
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.ARAKMU.REC.1396.33

Health conditions studied

1

Description of health condition studied
Primary Dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary Dysmenorrhoea

Primary outcomes

1

Description
Intensity Of Pain
Timepoint
Monthly
Method of measurement
Descriptive Criteria For Pain And Pain Ruler

Secondary outcomes

1

Description
Side effects of passion flower
Timepoint
Monthly
Method of measurement
questionnaire

Intervention groups

1

Description
In intervention group 1 ginger capsule (500 milligrams of ginger root powder), Golgardo Company manufactured in Iran and under the brand name Zinetuma three times a day at the beginning of the menstrual cycle, for three days In 2 months (monthly cycle)
Category
Treatment - Drugs

2

Description
In the third group (control group), one of the commonly used treatments for the treatment of the primary dysmenorrhea, ie, mefenamic acid (250 mg), with the ponstan brand name of Razak Company, is given 4 times every 6 hours for 2 months (monthly cycle).
Category
Treatment - Drugs

3

Description
in intervention group 2, Drop of passion flower with a brand name (Pas pp) made by Iran Daruk Company Iran (20 drops in the morning, 40 drops in the evening) 2 times a day for 2 months (monthly cycle)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khomein Health Centers
Full name of responsible person
Azam kerami Faculty Member
Street address
University Of Khomein Medical Sciences
City
Khomein

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University Khomein Medical Sciences
Full name of responsible person
Research Deputy Of Khomein Medical School
Street address
Khomein, College Khomein Medical Sciences
City
khomein
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University Khomein 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
University Khomein Medical Sciences
Full name of responsible person
Azam kerami
Position
Faculty Member
Other areas of specialty/work
Street address
University Khomein Medical Sciences
City
Khomein
Postal code
Phone
+98 86 4622 1533
Fax
Email
Azam_kerami@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University Of Medical Sciences, Khomein
Full name of responsible person
Azam kerami
Position
Faculty Member
Other areas of specialty/work
Street address
University Of Medical Sciences, Khomein
City
Khomein
Postal code
Phone
+98 86 4622 1533
Fax
Email
Azam_kerami@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University Of Medical Sciences, Khomein
Full name of responsible person
Azam kerami
Position
Faculty Member
Other areas of specialty/work
Street address
University Of Medical Sciences, Khomein
City
Khomein
Postal code
Phone
+98 86 4622 1533
Fax
Email
Azam_kerami@yahoo.com
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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