Protocol summary

Summary
This randomized, triple-blind clinical trial is with placebo control group, that is performing following the approval by the ethics committee of Shahid Beheshti University of Medical Sciences, International Branch, Tehran, Iran, In doing so, the researcher visit the students in their separate rooms, introduce herself and explaine the objectives of the study, and invite them to cooperate in the survey.Then students whom being single, age within 18e35 years, normal body mass index, regular menstrual cycle (21e35 days), with diagnosed PMS, no physical or psychological ill conditions, not on medication (hormonal, vitamins, herbal, antidepressant, aspirin, or warfarin), no history of allergy to herbal drugs, no sad event occurrence, no surgical operation during the last six months, not being a professional athlete, presence of at least five symptoms based on DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-fourth edition) for PMS diagnosis with confirmed one symptom out of the first four symptoms including (1. Feeling sad, hopeless or selfdeprecating, 2. Feeling tense, anxious, or “on edge”, 3. Marked liability of mood, interspersed with frequent tearfulness, 4. Persistent irritability, anger and increased interpersonal conflicts, 5. Decreased interest in usual activities that may be associated with withdrawal from social relationships), not being depressed based on Beck questionnaire. Those with the above mentioned criteria were entered into the study. An informed written consent was also given by each participant.PMS daily form: The participants filled the daily form of PMS consisting of 30 items on the symptoms divided into 15 physical ones including breast tenderness, headache, vertigo, bloating, weight gain, swollen extremities, palpitation, arthralgia and myalgia, sweating and chills, change in bowel movement, nausea, acne, recurrent herpes like infection, flushing and hotness, pelvic and abdominal pains and lassitude, fatigue and low energy state and 15 psychological, emotional and behavioral ones consisting of depression, anxiety, tension, emotional and affective instability, anger, irritability, loss of interest in daily routine activities, difficulty in concentration, forgetfulness, unjustified tendency to cry, avoiding socialization and contacts, preference for solitude, feeling of being out of control, change in sleeping pattern, change in appetite or overeating, desire to eat sweets and salt, and tendency to commit suicide.In doing so, the mean of severity was obtained and converted into percentage. Based on the percentages, the participants were divided into three groups; those with mild symptoms (below 33%), medium group (between 33% and 66%), and severe group (above 66%).then with using Eexel Software divided into two 45 person groups. And after obtaining the written consent of their medicines (45 person 3 capsules daily intake of 500 mg sage and 45 person 3 capsules of intake placebo) will be provided.

General information

Acronym
PMS (premenstrual syndrome)
IRCT registration information
IRCT registration number: IRCT201508268801N20
Registration date: 2016-05-30, 1395/03/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-30, 1395/03/10
Registrant information
Name
Masoumeh Simbar
Name of organization / entity
Shahid Beheshti University for Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2517
Email address
msimbar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University for Medical Sciences
Expected recruitment start date
2015-09-11, 1394/06/20
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of salvia officinalis on the Symptoms of Premenstrual Syndrome in the Dormitories Students of Shahid Beheshti University of Medical Science and Health Services
Public title
Evaluation the effect of salvia officinalis on premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being single; age between 18-35 years old; normal body mass index; regular menstrual cycle (21-35 days), with diagnosed PMS; no physical or psychological ill conditions; not on medication (hormonal, vitamins, herbal, antidepressant, aspirin, or warfarin); no history of allergy to herbal drugs; no sad event occurrence; no surgical operation during the last six months; not being a professional athlete; presence of at least five symptoms based on DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-fourth edition) for PMS diagnosis with confirmed one symptom out of the first four symptoms including (1. Feeling sad, hopeless or selfdeprecating, 2. Feeling tense, anxious, or “on edge”, 3. Marked liability of mood, interspersed with frequent tearfulness, 4. Persistent irritability, anger and increased interpersonal conflicts, 5. Decreased interest in usual activities that may be associated with withdrawal from social relationships); not being depressed based on Beck questionnaire. Those with the above mentioned criteria were entered into the study. An informed written consent was also given by each participant. Exclusion criteria: allergy to drugs; improper use of capsules and developing a significant disease and taking medications during the study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical commitee of Shahid Beheshti University of Medical Sciences
Street address
Medical Sciences University of Shahid Beheshti Nursing and Midwifery faculty of Shahid Behshti, Vali Asr intersection prayer in front of the Rajai Hospital Beheshti Department of Nursing and Midwifery
City
Tehran
Postal code
1985717443
Approval date
2015-11-01, 1394/08/10
Ethics committee reference number
IR.SBMU.PHNM.1394.181

Health conditions studied

1

Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle

Primary outcomes

1

Description
The severity of physical symptoms of premenstrual syndrome
Timepoint
Pre intervention, first month after intervention, second month after intervention
Method of measurement
Form a provisional dignosis of premenstrual syndrome from DSM5

2

Description
The severity of psychological symptoms of premenstrual syndrome
Timepoint
Pre intervention, first month after intervention, second month after intervention
Method of measurement
Daily form of severity of premenstrual syndrome

3

Description
The severity of symptoms of premenstrual syndrome
Timepoint
Pre intervention, first month after intervention, second month after intervention
Method of measurement
Daily form of severity of premenstrual syndrome

Secondary outcomes

1

Description
Side effects
Timepoint
First month after intervention, second month after intervention
Method of measurement
Questionnaire of effects and side effects of medication

Intervention groups

1

Description
Salvia officinalis extract, 500 mg capsule oral, 21st day till the 5th day of next cycle one capsule daily
Category
Treatment - Drugs

2

Description
Placebo, 500 mg capsule oral, 21st day till the 5th day of next cycle one capsule daily
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Dormity
Full name of responsible person
Roghayeh Abdnezhad
Street address
Vali- Asr Street at the corner of the Niayesh Street Oppsite the Rajaei heart hospital
City
Tehran

2

Recruitment center
Name of recruitment center
Yas Dormity
Full name of responsible person
Roghayeh Abdnezhad
Street address
Vanak Square, Khodami Street, Opposite Maskan Bank, No27
City
Tehran

3

Recruitment center
Name of recruitment center
Gol Narges Dormity
Full name of responsible person
Roghayeh Abdnezhad
Street address
Lower than the Vanak Square, Vali Asr Street, Opposite the Saei Park, Abshar Alley,No 75
City
Tehran

4

Recruitment center
Name of recruitment center
Hazrat Zeinab Dormity
Full name of responsible person
Roghayeh Abdnezhad
Street address
Shariati Street, Vahid Dastjerdi Street (Zafar Street), Near the Naft Street,Adjacent to the building Contacts, no 60
City
Tehran

5

Recruitment center
Name of recruitment center
Somayeh Dormity
Full name of responsible person
Roghayeh Abdnezhad
Street address
Shariati Street, Motahari Intersection, Southeast Side
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Besides of Taleghani Hospital, Shahid Aarabi Street, Yaman Street, Shahid Chamran Highway
City
Tehran
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
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
Medical Sciences University of Shahid Beheshti
Full name of responsible person
Roghayeh Abdnezhad
Position
master of midwifery
Other areas of specialty/work
Street address
tehran.Saadat Abad,Sarv intersection,Riazi Bakhshayesh Street, Ghaem Alley,No 19, third floor
City
Tehran
Postal code
1998897756
Phone
+98 21 2206 5410
Fax
Email
gilda_9a@yahoo.comgilda.9a@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Medical Sciences University of Shahid Beheshti
Full name of responsible person
Masoumeh Simbar
Position
PhD
Other areas of specialty/work
Street address
Nursing and Midwifery faculty of Shahid Behshti, Research Department
City
Tehran
Postal code
Phone
+98 21 8820 2517
Fax
Email
msimbar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Medical Sciences University of Shahid Beheshti
Full name of responsible person
Roghayeh Abdnezhad
Position
Master of Midwifery
Other areas of specialty/work
Street address
tehran,Saadat Abad, Sarv Intersection, Riazi Bakhshayesh Street, Ghaem Alley, No 19, Third floor
City
Tehran
Postal code
1998897756
Phone
+98 21 2206 5410
Fax
Email
gilda_9a@yahoo.comgilda.9a@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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