The aim of this study was to evaluate the local effect of ginger oil with oral ginger on the amount of menstrual bleeding in healthy people.
Design
The sample size was 35 in each group. Then, patients are randomly divided into two groups receiving ginger capsules or ginger oil. This study is one side blind.
Settings and conduct
the person who examines the severity of the symptoms and the analyst is unaware of the intervention of the two groups. Both groups consume the drug for three consecutive menstrual cycles according to the same instructions (from two days before the onset of bleeding to the first three days of hemorrhage every 6 hours)
Participants/Inclusion and exclusion criteria
People with inclusion criteria include no history of ginger allergy, no history of bleeding disorders, no history of gallstones. In case of occurrence, Exclusion criteria include pregnancy, drug allergy and personality disorder
Intervention groups
Ginger Oil; edible ginger; Between two groups of students living in Shahid Beheshti dormitory
Main outcome variables
Menstrual bleeding in healthy people
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140902019012N3
Registration date:2018-09-27, 1397/07/05
Registration timing:retrospective
Last update:2018-09-27, 1397/07/05
Update count:0
Registration date
2018-09-27, 1397/07/05
Registrant information
Name
Pantea Shirooye
Name of organization / entity
School of Traditional Medicineو, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 488 7140
Email address
pshirooye@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-02-18, 1395/11/30
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of topical ginger oil with oral ginger on the of menstrual flow
Public title
Comparing the effect of topical ginger oil with oral ginger on the of menstrual flow
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 45 years
Regular menstruation at intervals of 21 to 35 days and regular bleeding for 3 to 10 days at least in the last three cycles
Do not take other medications
Lack of susceptibility to ginger
No history of hemorrhagic diseases
Lack of history of gallstone
Exclusion criteria:
Pregnancy
Sensitization during the study
Menstrual disorder; Do not use the medicine properly; Use of another drug not defined in the study
Patients with severe potential side effects; Patients who need surgery and other interventions
Patients who decide to leave the study with a personal request.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Random unit: Individual
Randomization Tool: Random Numbers
Because the form of the drug is not the same in the two groups, only the person who examines the severity of the symptoms and finally, the analyst of the intervention of the two groups is unaware.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is a blind side.Because the drug is not the same in the two groups.Only the person who examines the severity of the symptoms and ultimately the analyst is unaware of the intervention of the two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Science,Velenjak,Tehran
City
Tehran
Province
Tehran
Postal code
۶۱۵۳_۱۴۱۵۵
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.572
Health conditions studied
1
Description of health condition studied
Menorrhagia
ICD-10 code
N92.0
ICD-10 code description
Excessive and frequent menstruation with regular cycle
Primary outcomes
1
Description
Menstrual bleeding
Timepoint
cycle before intervention, every cycles during intervention (3 cycles)
Method of measurement
PBAC questionnaire
Secondary outcomes
1
Description
side effect: Stomachache, nasea, vomiting, hematemesis, belch, fatigue, itching, acne, heartburn, diarrhea, constipation, melena,headache, drowsiness, redness, assessment of bleeding with PBAC
Timepoint
cycle before intervention, every cycle during intervention (3 cycles)
Method of measurement
questionnaire
Intervention groups
1
Description
Ginger capsule, which is used for treatment and not placebo. Ingredients: Dried rhizome of ginger was prepared as needed to prepare ginger capsules. Each capsule is filled with 250 mg of ginger powder
Category
Treatment - Drugs
2
Description
Ginger Oil To grind ginger oil, ginger rhizomes are crushed and soaked in sesame oil in a ratio of one (ginger) to five (sesame oil). Then the oil becomes smooth. Microbial control tests include the determination of the total number of aerobic organisms and the absence of Salmonella, Pseudomonas, Staphylococcus and Ecoli.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti university campus
Full name of responsible person
Mrs. Zaem
Street address
Shams Alleg., Vali-eAsr Ave., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 8877 3521
Email
pshirooye@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Iranian Traditional Medicine of Shahid Beheshti University of Medical Science
Full name of responsible person
Somaye Esmaeili
Street address
Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 8877 3521
Email
pshirooye@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Iranian Traditional Medicine of Shahid Beheshti University of Medical Science
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
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pantea Shirooye
Position
Traditional medicine PHD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 8877 3521
Fax
Email
pshirooye@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pantea Shirooye
Position
Traditional medicine PHD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 8877 3521
Fax
Email
pshirooye@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pantea Shirooye
Position
Traditional medicine PHD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 8877 3521
Fax
Email
pshirooye@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
The questionnaires used and the information about the main outcome after the 3 months of publication of the results are shared with the applicants.
When the data will become available and for how long
Start the access period 3 months after printing the results
To whom data/document is available
Researchers working in institutions academic and scientific
What processes are involved for a request to access data/document
After 6 months of sampling and 2 months of statistical analysis and 3 months after printing results It takes about 14 months to complete. Information is provided to the applicant