Objective: The aim of this study was to evaluate the effect of Aloe vera on pain relief in primary dysmenorrhea.
Setting and conduct: The study was conducted at Zahedan University of Medical Sciences Dormitory.
Design: The present study was a double-blind, randomized clinical trial. Eighty students with primary dysmenorrhea who signed consent form were participated in this study. Based on random numbers table, the samples were equally divided into two groups and received 1:1 ratio Aloe vera and placebo. All gel bottles were coded at Barij Essence pharmaceutical company which made the products. Because of preventing bias, the researcher and participants did not informed of the kind of oral gel. Inclusion criteria: having score 4 to 10 for dysmenorrhea according to pain scale, no history or no having of uterus and pelvic disease. Exclusion criteria: allergy to drug and take inappropriate dosage and forget the time table.
Intervention: The participants took 5cc of oral gel three times a day (two days before until three days after menstrual cycle for two consecutive cycles). If they need to use NSAIDs, allowed them but they must recorded the severity of pain before consumption of the sedative. A self-reported checklist was used to collect information on the number of sedative drugs and condition of menstrual. Also visual analog scale was used to determine severity of pain.
Outcome: Severity of pain was assessed at 5 time intervals (first 2 hours from onset of menses, 2 to 12 hours, 12 to 24 hours, second and third day of menstrual cycle).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206069957N1
Registration date:2013-01-29, 1391/11/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-29, 1391/11/10
Registrant information
Name
Somayeh Khazaiyan
Name of organization / entity
Zahedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 54 1323 1207
Email address
khazaiyan@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology, Zahedan University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of oral Aloe vera gel on severity of primary dysmenorrhea in students of Zahedan University of Medical Sciences
Public title
The effect of Aloe vera gel on menstrual pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being unmarried, having score 4 to 10 for dysmenorrhea according to pain scale, not known chronic diseases, having regular menstrual periods between 21 to 35 days, no history of myoma, pelvic tumor, andometriosis and pelvic inflammatory disease, no taking oral particular drug, no history of allergy to herbal drugs. Exclusion criteria: allergy to Aloe vera during intervention, incorrect taking the drug.
Age
From 18 years old to 25 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Zahedan University of Medical Sciences
Street address
Pardis University of Medical Sciences Campus, Hessabi Sq
City
Zahedan
Postal code
9816743463
Approval date
2011-12-08, 1390/09/17
Ethics committee reference number
90-1666
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Severity of primary dysmenorrhea
Timepoint
3 menstrual cycles, one cycle before the study and 2 cycles during the study with 5 time intervals: first 2 hours from onset of menses, 2 to 12 hours, 12 to 24 hours, second day and third day of menstrual cycle
Method of measurement
verbal multidimensional scoring system and visual analogue scale
Secondary outcomes
1
Description
Nausea
Timepoint
during first 3 days of the menstrual period and at the end of the menstrual period for 2 cycles of intervention
Method of measurement
Questionnaire (Yes, No)
2
Description
Vomiting
Timepoint
during first 3 days of the menstrual period and at the end of the menstrual period for 2 cycles of intervention
Method of measurement
Questionnaire (Yes, No)
3
Description
Diarrhea
Timepoint
during first 3 days of the menstrual period and at the end of the menstrual period for 2 cycles of intervention
Method of measurement
Questionnaire (Yes, No)
4
Description
Headache
Timepoint
during first 3 days of the menstrual period and at the end of the menstrual period for 2 cycles of intervention
Method of measurement
Questionnaire (Yes, No)
5
Description
Itching
Timepoint
during first 3 days of the menstrual period and at the end of the menstrual period for 2 cycles of intervention
Method of measurement
Questionnaire (Yes, No)
6
Description
Hives
Timepoint
during first 3 days of the menstrual period and at the end of the menstrual period for 2 cycles of intervention
Method of measurement
Questionnaire (Yes, No)
Intervention groups
1
Description
The Aloe vera group took 1 tablespoon Aloe vera gel by oral three times per day from two days before and three days after the beginning of menstrual cycle for two consecutive cycles.
Category
Treatment - Drugs
2
Description
The placebo group took 1 tablespoon placebo gel by oral three times per day from two days before and three days after the beginning of menstrual cycle for two consecutive cycles.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
The dormitory of Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Meskarani
Street address
Pardis University of Medical Sciences Campus, Hessabi Sq
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Zahedan University of Medical Sciences
Full name of responsible person
Dr.Hamid Reza Mahmoodzade Sagheb
Street address
Pardis University of Medical Sciences Campus, Hessabi Sq
City
Zahedan
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 and Technology, Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahdiye Donyadari
Position
BSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashahir Sq
City
Zahedan
Postal code
9819613396
Phone
+98 54 1243 8473
Fax
Email
m_20282000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shahin_ Dokht Navvabi Rigi
Position
Faculty of Midwifery / MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashahir Sq
City
Zahedan
Postal code
Phone
+98 54 1341 6706
Fax
+98 54 1341 6708
Email
shahinnavabi@yahoo.com
Web page address
www.zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Somaye Khazaiyan
Position
Faculty of Midwifery / MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashahir Sq
City
Zahedan
Postal code
Phone
00985412419403_327
Fax
Email
m_khazaiyan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)