Determining and comparing the effect of Fennelin and diclofenac, on primary dysmenorrhea
Design
A clinical trial with two intervention groups,Double blind study ,Randomized by block method ,on 100 patients.
Settings and conduct
The study will be conducted on women with dysmenorrhea who refer to specialized gynecology and obstetrics clinics and medical centers. If they have moderate to severe primary dysmenorrhea, they will be included in the study. They will be randomly divided into two intervention groups using the randomized block method. It will be performed in a double-blind manner, so that the patients and the researcher will not know the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
moderate and severe dysmenorrhea،Age between15-30 years،Regular menstruation
Intervention groups
Intervention group 1: Fennelin 30 mg Pearl manufactured by Barij Essential Oil Pharmaceutical Company is taken three times a day for 4 days, one tablet each time and in two menstrual cycles. Intervention group 2: Diclofenac 100 mg tablet manufactured by Hakim Pharmaceutical Company, three times a day for 4 days. And every time one number is consumed in two menstrual periods
Main outcome variables
severity of dysmenorrhea,Nausea ؛vomiting ؛back pain with dysmenorrhea
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20220512054829N2
Registration date:2022-10-28, 1401/08/06
Registration timing:retrospective
Last update:2022-10-28, 1401/08/06
Update count:0
Registration date
2022-10-28, 1401/08/06
Registrant information
Name
Hossein Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0111
Email address
akbari1350_h@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-30, 1401/05/08
Expected recruitment end date
2022-08-19, 1401/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparsion of the effect of Fennelin and diclofenac on primary dysmenorrhea
Public title
effect of Fennelin on primary dysmenorrhoea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Regular menstruation
Moderate and severe dysmenorrhea
Age between 15-30
Exclusion criteria:
People with underlying diseases
User of other drugs
genital diseases
Age
From 15 years old to 30 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Randomization is done with the block method (Permuted block randomization) so that first All blocks of four that include two codes A and B (6 blocks) are prepared and numbers from 1 to 6 are assigned to each of them. Then, using the table of random numbers, each number from 1 to 6 that is selected, the block corresponding to each code will be written(25 blocks). Based on this, a sequence of codes A and B is prepared for 100 codes (proportionate to the number of samples). Then, each of the letters A and B is randomly assigned to one of the fennelin and diclofenac groups. The same code is recorded on each drug and will remain with the formulation department until the end of the study. At the end of the study, the code of the drugs in the form of A and B will be provided to the statistical analyst for analysis.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs in both groups are packaged In vials of one shape and one size in the formulation section of Barij Essential Oil Pharmaceutical Company, then coded based on codes previously prepared using a random number table.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Medicine & Faculty of Dentistry- Kashan University of Medical Science
Street address
Kashan University of Medical Sciences ،Pezeshk street ،Ghotb ravandi BLVD
City
Kashan
Province
Isfehan
Postal code
8715985131
Approval date
2022-07-03, 1401/04/12
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.068
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Moderate to severe dysmenorrhoea according to Andresh and Milsom questionnaire
Timepoint
Examination of the severity of dysmenorrhea at the beginning of the study before the intervention and on the 1st, 2nd, 3rd and 4th day of menstruation after the intervention.
Method of measurement
Andres and Milsom questionnaire
Secondary outcomes
1
Description
Nausea with dysmenorrhea
Timepoint
At the beginning of drug use and days 1, 2, 3, and 4 of dysmenorrhea in two consecutive menstrual periods
Method of measurement
Andrash and Milsom questionnaire
2
Description
Vomiting with dysmenorrhea
Timepoint
At the beginning of drug use and days 1, 2, 3, and 4 of dysmenorrhea in two consecutive menstrual periods
Method of measurement
Andrash and Milsom questionnaire
3
Description
Back pain with dysmenorrhea
Timepoint
At the beginning of drug use and days 1, 2, 3, and 4 of dysmenorrhea in two consecutive menstrual periods
Method of measurement
Andrash and Milsom questionnaire
Intervention groups
1
Description
Intervention group 1: People take one 30 mg pearl fennelin three times a day after meals with the onset of dysmenorrhea. Each milliliter of this substance contains less than 11.4 mg of anthole as an active ingredient. Phenylin has similar packaging as Diclofenac with the name "Stapin" is designed by Barij Essential Oil Pharmaceutical Company .The drug is used for two menstrual periods and for four days in each period
Category
Treatment - Drugs
2
Description
Intervention group 2: People take one 100 mg diclofenac tablet three times a day with the onset of dysmenorrhea after meals. Diclofenac has the same packaging as fennelin with the name "Stopain" designed by Hakim Pharmaceutical Company .The drug is used for two menstrual periods and for four days in each period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Clinic, Kashan
Full name of responsible person
Zahra Vahedpour
Street address
Shahid Beheshti Hospital,Qutb Rawandi BLVD
City
Kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5554 0111
Fax
+98 31 5554 0111
Email
zink300@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Kashan University of Medical Sciences, Qutb ravandi BLVD
City
Kashan
Province
Isfehan
Postal code
8715985131
Phone
+98 31 5554 0029
Fax
+98 31 5554 0029
Email
hamidi_gh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
It is possible to share some of the data
When the data will become available and for how long
The access period begins one year after the publication of the article
To whom data/document is available
All faculty members of medical universities
Under which criteria data/document could be used
If they want to do more accurate statistical analysis on the data
or use newer diagnostic methods to measure the outcome of the intervention
From where data/document is obtainable
Call and email
What processes are involved for a request to access data/document
By calling or e-mailing the person in charge and signing a memorandum of cooperation regarding the service he is going to provide and the benefits that will reach the parties.