Due to prevalence of PMS and adverse effects of current treatments, the effectiveness of soft capsule containing anis oil, sage oil compared with placebo soft capsule on clinical symptoms of PMS
Design
Double Blind randomized placebo control clinical study
Settings and conduct
Students resident in dominants of Chalus University of Medical Science
Participants/Inclusion and exclusion criteria
90 girls with PMS
Students at the ages of 18-35 years old
Students with normal BMI between 18.5-25.9
No smoking
Bleeding duration between 3-10 days in two months before the research
Regular menstruation with cycles of 21-35 days
Confirmation of PMS on the base of PMS questionnaire and daily statement form
No identified psychological diseases
No identified diseases such as diabetes, seizure disorders, hypothyroidism
No death of relatives or accidents during last 6 months
No surgical operation during the last 6 months
Not using of anti-depressant drugs, hormones, contraceptives, medroxy progesterone acetate, vitamins the last three months before the study
Intervention groups
Herbal Soft capsule
Placebo Soft Capsule
Main outcome variables
The effects of soft capsule containing anise oil, sage on clinical symptoms (physical and psychological) symptoms of students
General information
Reason for update
Acronym
PMS
IRCT registration information
IRCT registration number:IRCT20190306042943N1
Registration date:2019-04-25, 1398/02/05
Registration timing:prospective
Last update:2019-04-25, 1398/02/05
Update count:0
Registration date
2019-04-25, 1398/02/05
Registrant information
Name
Mohaddese Mahboubi
Name of organization / entity
Tabibdaru
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 1000
Email address
mahboubi1357@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of soft capsule containing anise, sage oil in PMS
Public title
Herbal Soft Capsule in treatment of PMS
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Students at the ages of 18-35 years old
Students with normal BMI between 18.5-25.9
No smoking
Bleeding duration between 3-10 days in two months before the research
Regular menstruation with cycles of 21-35 days
Confirmation of PMS on the base of PMS questionnaire and daily statement form
No identified psychological diseases
No identified diseases such as diabetes, seizure disorders, hypothyroidism
No death of relatives or accidents during last 6 months
No surgical operation during the last 6 months
Not using of anti-depressant drugs, hormones, contraceptives, medroxy progesterone acetate, vitamins the last three months before the study
Exclusion criteria:
Incidence of accidents like death of relatives
The use of supplements, or vitamins
Misuse of drugs, which the patients do not obey the protocol
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is used for patients, and the individuals randomly divided in two groups of intervention and control.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The herbal soft capsules are prepared in formulation unit of Tabib Daru. The placebo soft capsule will prepare by sunflower without effective compound. If the herbal soft capsule have odor, the placebo soft capsules will put near the herbal soft capsule for two weeks
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Department of Midwifry, School of Nursing and Midwifery, Shahid Beheshti Medical Science University
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.271
Health conditions studied
1
Description of health condition studied
PMS
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
The severity of psychological and physical symptoms of PMS
Timepoint
Before and after treatments
Method of measurement
Daily Record of Severity of Problems questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 500 mg Soft Capsule containing anise oil, sage oil, twice daily, from the day of 21 menstruation until 2 days after bleeding during two menstrual cycles.
Category
N/A
2
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Calous University of Medical Science
Full name of responsible person
Dr. Masoumeh Simbar
Street address
SBMU School of Nursing & Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5376
Email
msimbar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabib Daru Dez
Full name of responsible person
Dr. Mohaddese Mahboubi
Street address
No 3, Homa building, Motahari Street
City
Kashan
Province
Isfehan
Postal code
8715115815
Phone
+98 31 5554 1000
Email
mahboubi1357@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabib Daru Dez
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
2
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Simbar
Street address
Shahid Beheshti Medical university School of Nursing & Midwifery, Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5376
Email
msimbar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tabibdaru
Full name of responsible person
Mohaddese Mahboubi
Position
Research and Development Manager
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Homa Building, Motahari Street, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715115815
Phone
+98 31 5554 1000
Fax
+98 31 5554 1000 ext. 105
Email
mahboubi1357@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabibdaru
Full name of responsible person
Mohaddese Mahboubi
Position
Research and Development Manager
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Homa Building, Motahari Street, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715115815
Phone
+98 31 5554 1000
Fax
+98 31 5554 1000 ext. 105
Email
mahboubi1357@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabibdaru
Full name of responsible person
Mohaddese Mahboubi
Position
Research and Development Manager
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Homa Building, Motahari Street, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715115815
Phone
+98 31 5554 1000
Fax
+98 31 5554 1000 ext. 105
Email
mahboubi1357@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no furthur information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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