The goal of this study is to reduce the Premenstrual syndrome by using Saffron causing lees side effects than Fluoxetine.
This study was a double- blind (Phase3) (none of the patients, researchers and analysts was aware of the contents of the capsules). that was performed on women that working in healt center and their relatives. 164 women with informed consent and Premenstrual Syndrome (Based on the previous menstrual cycle and the Hamilton Test) were selected and randomly allocated in 2 groups. each group consisted of 82 women. One group received treatment with fluoxetine and one group with saffron. Cuses were treatment for 2 months. They used a capsule daily from 14 to 28 cycles. they completed the checklist Includes: Masstalgia, Abdominal Pain, Abdominal Bloat, Deppretion, Anexity in 5 daye later.
inclusion criteria is informed consent, Eighteen to forty years, regular Menstrual Periods( 35-21 days),
Normal cycle (10-3 day) and Exclusion criteriah is Underlying disease.
General information
Acronym
PMS
IRCT registration information
IRCT registration number:IRCT2017061233202N2
Registration date:2017-09-08, 1396/06/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-08, 1396/06/17
Registrant information
Name
Atefeh Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 9180
Email address
a.asadi.mm.1384@gmail.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Saffron and Fluoxetine in treatment women that have Premenstrual Syndrome
Public title
Effect of Saffrons in Premenstrual Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: informed consent; Eighteen to forty years; regular Menstrual Periods( 35-21 days); Normal cycle (10-3 day); Physical and Mental health; The absence of anemia in the past three months ; Having one or more Symptoms of Premenstrual Syndrome in 2 consecutive cycles; no Pregnancy intention.
Exclusion criteria: Underlying disease; Taking other drugs
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study was adouble-blinded study, the researcher, analyst, and recipients were not aware of the contents of the capsule. Only doctor in charge is aware of the contents of the capsule (with the numbered code on the package of the first and second capsule ) .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Assadabadi Street
City
Sabzevar
Postal code
Approval date
2017-04-10, 1396/01/21
Ethics committee reference number
(IR.MEDSAB.REC.1395.148
Health conditions studied
1
Description of health condition studied
Premenstual Syndrom
ICD-10 code
N94
ICD-10 code description
Unspecified condition associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
Masstalgia
Timepoint
From 14 to 28 cycles are recorded on a daily basis
Method of measurement
Vigual Scare
2
Description
Abdominal Pain
Timepoint
From 14 to 28 cycles are recorded on a daily basis
Method of measurement
Vigual Scare
3
Description
Abdominal Bloat
Timepoint
From 14 to 28 cycles are recorded on a daily basis
Method of measurement
weist size
4
Description
Deppretion
Timepoint
From 14 to 28 cycles are recorded on a daily basis
Method of measurement
Test Deppretion Beck
5
Description
Anexity
Timepoint
From 14 to 28 cycles are recorded on a daily basis
Method of measurement
Test anxiety Beck
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: saffron, self-made capsule 30 mg, oral, once a day from fourteen to twenty-eight day menstrual cycle for two month.
Category
Treatment - Drugs
2
Description
Control groups: fluoxetine, capsule 20 mg, oral, once a day from fourteen to twenty-eight day menstrual cycle for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Health Sabzevar
Full name of responsible person
Atefeh Asadi
Street address
Department of Health, Talghani Street, Sabzevar
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Mohammadzadeh
Street address
University Compound ; Unity Road Town
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Atefeh Asadi
Position
Health Department of Laboratory Medicine , Sabzevar
Other areas of specialty/work
Street address
Talghani Streete
City
Sabzevar
Postal code
Phone
+98 51 4464 5620
Fax
Email
a.asadi.mm.1384@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Atefeh Aasadi
Position
General Practitioner
Other areas of specialty/work
Street address
Assadabadi Street
City
Sabzevar
Postal code
Phone
+98 51 4422 9180
Fax
Email
a.asadi.mm.1384@gmail.comaa.9157638703@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Nematshahy
Position
Anesthesiologist
Other areas of specialty/work
Street address
Heshmatieh Hospital, Asadabadi Street, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4401 1900
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)