Protocol summary
-
Study aim
-
Effect of Ginger and Chamomile Mixed Sachet with Honey in The Treatment of Primary Dysmenorrhea and Associated Symptoms and Also Detection of Uterine Humor
-
Design
-
This study is a clinical trial and patients will divide randomly by block random sampling. 400 patients will divide to four groups by block random sampling, so that 100 people randomly will assign to each group.
-
Settings and conduct
-
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 2 menstrual cycles. After the first and second cycle, the questionnaires will be filling to measure the amount of pain, bleeding severity, duration of bleeding and other symptoms of dysmenorrhea.
-
Participants/Inclusion and exclusion criteria
-
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;
-
Intervention groups
-
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.
-
Main outcome variables
-
The severity of bleeding, Duration of bleeding, The severity of pain, Symptoms of dysmenorrhea
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2016100825031N5
Registration date:
2016-11-08, 1395/08/18
Registration timing:
registered_while_recruiting
Last update:
2018-04-19, 1397/01/30
Update count:
1
-
Registration date
-
2016-11-08, 1395/08/18
-
Registrant information
-
-
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
-
2017-10-21, 1396/07/29
-
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
-
- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
-
Sample size
-
Target sample size:
280
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
For Blindness and randomization will be used from numbered closed envelopes and block sampling
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
For Blindness will be used from numbered closed envelopes. Patients, researcher, physicians and statistical adviser do not know about the type of drug and groupings.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
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
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
1
-
Sponsor
-
-
Grant name
-
-
-
Grant code / Reference number
-
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Arak 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
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
-
Undecided - It is not yet known if there will be a plan to make this available