Comparison of the Efficacy of Ginger-Chamomile Mixed Sachet and Honey with Mefenamic Acid in The Treatment of Primary Dysmenorrhea and Associated Symptoms of Female Students that Living in the Arak University of Medical Sciences Dormitory: Randomized Controlled Clinical Trial
Objectives: Effect of Ginger (Zingiber Officinale) and Chamomile Mixed Sachet with Honey in The Treatment of Primary Dysmenorrhea and Associated Symptoms
Design: This study is a clinical trial and patients will divide randomly by block random sampling. 280 patients with inclusion criteria will divide to four groups by block random sampling, so that 70 people randomly will assign to each group. For the studied staffs will be providing same brand sanitary napkin without absorbent so that they have will put in the same condition. For the ginger and chamomile mixed group, will provide sachets containing 1000 mg of ginger root powder and 5000 mg of chamomile, for the ginger group, will provide sachets that contain 1000 mg of ginger root powder and for the chamomile group, will provide sachets that contain 5000 mg of chamomile. During the menstrual cycle, patients of three groups will must dissolve the sachet in a glass of water and after heating, consume that with a teaspoonful of honey. For the mefenamic acid group, will provide 250 mg mefenamic acid capsules. Prescribing instruction is similar in all groups, patients will must start consuming sachets and capsules, 2 day before menstrual cycle and continue that to 3 day after the beginning of menstrual cycle, 3 time a day for 3 menstrual cycles. After the first and third cycle, the questionnaires will be filling to measure the amount of pain, bleeding severity, duration of bleeding and other symptoms of dysmenorrhea. The results in each group and between all groups will be comparing before, during and after the intervention.
Inclusion criteria:
Between 18 to 30 years old; Unmarried; Lack of chronic diseases; Without peptic ulcer or duodenal ulcer; Do not consume anticoagulant drugs; Do not consume oral contraceptives; Avoiding to use alcohol;
Exclusion criteria:
Patient's refusal to participate in the study; Consume drugs irregularly; Marriage; Do not fill out the questionnaire;
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100825031N5
Registration date:2016-11-08, 1395/08/18
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-11-08, 1395/08/18
Registrant information
Name
Fatemeh Rafiei
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3226 5732
Email address
a.rafiei@tafreshu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
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
Comparison of the Efficacy of Ginger-Chamomile Mixed Sachet and Honey with Mefenamic Acid in The Treatment of Primary Dysmenorrhea and Associated Symptoms of Female Students that Living in the Arak University of Medical Sciences Dormitory: Randomized Controlled Clinical Trial
Public title
Effect of Ginger (Zingiber Officinale) and Chamomile Mixed Sachet with Honey in The Treatment of Primary Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Between 18 to 30 years old; Unmarried; The menstruation pain is started before 20 years old; Regular menstrual cycles between 21 to 35 days; Menstrual bleeding without passing clots; Menstrual pain start a few hours before menstrual bleeding and to continue for 5 days; Lack of chronic diseases; Without peptic ulcer or duodenal ulcer; Do not consume anticoagulant drugs; Lack of burning, itching and abnormal vaginal discharge; Without history of allergy to medicinal plants; Lack of stress in the past two months; Do not have to take medicine or special diet and smoking; Without history of pelvic inflammatory disease; Without history of gynecologic surgery; Do not transfer or relocation during the next 6 months; Do not have pain in all the time of menstrual bleeding; Do not consume oral contraceptives; Do not consume drugs class of benzodiazepines, barbiturates, narcotics and some antidepressants, such as fluoxetine; Avoiding to use alcohol, aspirin, warfarin and heparin; Without having specific diseases of liver, kidney and diagnosed depression;
Exclusion criteria:
Patient's refusal to participate in the study; Consume drugs irregularly; The incidence of significant stress factors during the study; The incidence of any disease that requires to consume drugs, nutritional supplements or vitamins for long-term; Doing any type of surgery during the study; Marriage or change location; Do not fill out the questionnaire; Unwillingness to continue consume their medication by patients; Avoiding the consume of medication as a single dose;
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:
280
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Postal code
Approval date
2016-07-25, 1395/05/04
Ethics committee reference number
IR.ARAKMU.REC.1395.164
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
The severity of bleeding
Timepoint
Before intervention and after the first and third menstrual cycle
Method of measurement
(PBACs) Pictorial Blood Loss Assessment Chart
2
Description
Duration of bleeding
Timepoint
Before intervention and after the first and third menstrual cycle
Method of measurement
Measuring time
3
Description
The severity of pain
Timepoint
Before intervention and after the first and third menstrual cycle
Method of measurement
Visual analog scale
4
Description
Symptoms of dysmenorrhea
Timepoint
Before intervention and after the first and third menstrual cycle
Method of measurement
Verbal scale Anthresh - Mylsum
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: sachet containing 1000 mg of ginger root powder and 5000 mg of chamomile with a teaspoonful of honey; 3 time a day, from 2 day before the beginning of menstrual cycle until 5 day
Category
Treatment - Drugs
2
Description
Group 2: sachet that contain 1000 mg of ginger root powder with a teaspoonful of honey; 3 time a day, from 2 day before the beginning of menstrual cycle until 5 day
Category
Treatment - Drugs
3
Description
Group 3: sachet that contain 5000 mg of chamomile with a teaspoonful of honey; 3 time a day, from 2 day before the beginning of menstrual cycle until 5 day
Category
Treatment - Drugs
4
Description
Group 4: 250 mg mefenamic acid capsule manufactured by Raha pharmaceutical company; 3 time a day, from 2 day before the beginning of menstrual cycle until 5 day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Girl's Dormitory of Arak University of Medical Sciences
Full name of responsible person
Fatemeh Shabani
Street address
Girl's Dormitory of Arak University of Medical Sciences, Arak, Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Arak University of Medical Sciences