This is a Single blind randomized clinical trial that will be done on females of 20-40 y/o admitting clinics with chief complaint of oligomenorrhea. The Study goal is to compare the effect of Sesamum indicum L. and medroxyprogestron on oligomenorrhea. The Inclusion criteria are: 20-40 y/o women with cessation of menstrual bleeding for more than 14 days that has been repeated for at least 3 episodes during the last year and are not pregnant or lactating. The exclusion criteria are: using hormonal drugs during the study or those who decide to exit the study. The overall sample size is 50, which will be divided in to the herbal drug (25 patients) and the control group (25 patients). After prescribing the herbal drug (Sesamum 60 grams daily) or the standard therapy (Medroxy Progestrone acetate 10 mgs daily) for one week, the patients will be followed for 2 and 4 weeks and will be asked for menstruation bleeding initiation, time to start the therapeutic effect, dysmenorrhea and possible treatment side effects. The response rate will be compared between the groups using t student test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072014072N1
Registration date:2013-12-21, 1392/09/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-21, 1392/09/30
Registrant information
Name
Maryam Yavari
Name of organization / entity
Shaheed Beheshty University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
mahnam@eng.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-12-11, 1392/09/20
Expected recruitment end date
2014-02-25, 1392/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Sesamum indicum L. and medroxyprogestron on oligomenorrhea: a Single blind randomized clinical trial
Public title
Comparison of the effect of Sesamum indicum L. and medroxyprogestron on menstrual bleeding cessation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 20-40 y/o women; willing to participate in the study;
cessation of menstrual bleeding for more than 14 days that has been repeated for at least 3 episodes during the last year; negative pregnancy test; not in lactation period; not affected by: diabetes, hypertension, organic disease and malignancies, chronic disease of the liver and kidneys; not using any kind of hormonal drugs(e.g. OCP)
Exclusion criteria: Using hormonal drugs or any drug that will affect menstruation during the treatment period; patients willing to exit the study; patients that need invasive treatments during the study
Exclusion criteria:
Using hormonal drugs during the study
experiencing drugs side effects
patients who need interventions like surgery procedures
those who will to exit the study
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshty University of Medical Sciences Etic Commitee
Street address
Velenjak St., Shahid Chamran Highway
City
Tehran
Postal code
Approval date
2013-12-01, 1392/09/10
Ethics committee reference number
143
Health conditions studied
1
Description of health condition studied
Oligomenorrhea
ICD-10 code
N91.4
ICD-10 code description
Secondary Oligomenorrhoea
Primary outcomes
1
Description
menstrual bleeding initiation
Timepoint
2 weeks and 4 weeks after finishing the drug consumption
Method of measurement
interview
2
Description
waiting period before menstrual bleeding
Timepoint
2 weeks after finish the drug consumption
Method of measurement
interview
Secondary outcomes
1
Description
weight gain
Timepoint
during the study
Method of measurement
interview
2
Description
hyrsutism
Timepoint
during the study
Method of measurement
interview
3
Description
Acne
Timepoint
during the study
Method of measurement
interview
4
Description
nausia
Timepoint
during the study
Method of measurement
interview
Intervention groups
1
Description
Sesame seed product: 60 g daily for one week
Category
Treatment - Drugs
2
Description
Medroxyprogesterone acetate 5 mg tablets BID for one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshty Hospital
Full name of responsible person
Dr Safoura Rouholamin
Street address
Motahari St., beside Felezi Brg.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshty University of Medical Sciences
Full name of responsible person
Dr Somaye Esmaeili
Street address
Shams alley, Tavanir St., Valiasr st.,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshty 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
Faculty of Traditional Medicine, Shahid Beheshty University of Medical Sciences
Full name of responsible person
Dr Maryam Yavari
Position
PhD candidate
Other areas of specialty/work
Street address
Shams alley, Tavanir st., Valiasr st.
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
yavari@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshty University of Medical Sciences
Full name of responsible person
Dr Mojgan Tansaz
Position
MD, PhD in Traditional medicine
Other areas of specialty/work
Street address
Shams Alley., Valiasr st.,
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
mojgan_tansaz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of ztraditional Medicine, Shahid Beheshty University of Medical Sciences
Full name of responsible person
Maryam Yavari
Position
Student
Other areas of specialty/work
Street address
Shams alley, Valiasr st.,
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)