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The Impact Of Valerian Root Extract On Pre Menstural Syndrome Symptoms

Protocol summary

Summary
The aim of this study is to assess The Impact of Valerian Root Extract On PreMenstural Syndrome Severity of Symptoms. Inclusion criteria: Single, 18-35 years,Having regular menstrual cycles and normal 21-35 and Duration of 7-3 days in the last 6 months, Lack of physical and emotional illness known And use of a Use of certain medications,no Occurrence of stressful events during the 3 months before study And diagnosis of premenstrual syndrome according to the Daily Form, Failure to participate in research studies of similar. Exclusion criteria of the study, Lack of volunteers willing to Continued drug use,Occurrence drug allergies, Stopping the medication for a week in the first cycle and irregular use of medication in cycles 2 and 3 for two days,Understanding of physical and mental illness during the study, Married during the study, Relatives death relatives and had surgery during the past two months. This study was conducted on 100 students at dormitory of University - Tonekabon Branch. Students initially recorded daily symptoms for two menstrual cycles completed. Students with random assignment to treatment groups (capsule Sedamin 530 mg) and placebo control groups. Each student taking the drug daily for three consecutive menstrual cycle taking two last seven days And her symptoms were recorded daily symptom questionnaire. Consequence of this Study for the students is the reduction of the severity of mental, physical and behavior symptoms of premenstrual syndrome.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201211179463N5
Registration date: 2013-04-14, 1392/01/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-04-14, 1392/01/25
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-09-06, 1392/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact Of Valerian Root Extract On Pre Menstural Syndrome Symptoms
Public title
The Impact Of Valerian Root Extract On Pre Menstural Syndrome Symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Single, 18-35 years, Having regular menstrual cycles and normal 21-35 and Duration of 7-3 days in the last 6 months, Lack of physical and emotional illness known And use of a Use of certain medications, no Occurrence of stressful events during the 3 months before study And diagnosis of premenstrual syndrome according to the Daily Form, Failure to participate in research studies of similar. Exclusion criteria of the study, Lack of volunteers willing to Continued drug use, Occurrence drug allergies, Stopping the medication for a week in the first cycle and irregular use of medication in cycles 2 and 3 for two days, Understanding of physical and mental illness during the study, Married during the study, Relatives death relatives and had surgery during the past two months. and third cycles are some criteria for stopping the study ; Understanding of physical and mental illness during the study; Married during the study; Relatives death and had surgery during the past two months .)
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
factulty of nersing and midwifery of Tehran University of Medical Sciences
City
tehran
Postal code
Approval date
2013-03-03, 1391/12/13
Ethics committee reference number
3183/130/د/91

Health conditions studied

1

Description of health condition studied
Premenstural Syndrome
ICD-10 code
F59
ICD-10 code description
Unspecified behavioural syndromes associated with physiological disturbances and physical factors

Primary outcomes

1

Description
Reduction in physical symptoms (headache, breast swelling and tenderness, back pain, abdominal pain, muscle pain, Overweight, swelling of extremities, nausea, bloat)
Timepoint
One month, two months, three months after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Reduction in mood symptoms (anxiety and Worry, Restlessness, Nervous tension, Get angry, Snappish, irritableity, depression Withdrawal and irritability and sadness, crying for no reason, feeling alone, Freak out, Behavioral inconsistency)
Timepoint
One month, two months, three months after intervention
Method of measurement
Questionnaire

2

Description
Reduction in behavioral symptoms (fatigue lack of energy, insomnia, difficulty concentrating, increased appetite)
Timepoint
One month, two months, three months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
in imterventional groug:Sedamin Capsules, 530 mg, 2 times a day, orally for 3 months
Category
Placebo

2

Description
in control group:Placebo capsules, 2 times a day, orally for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
dormitory of Islamic Azad University - Tonekabon Branch
Full name of responsible person
Roghaye shiroodgholami
Street address
tonekabon-valiaba Islamic Azad University - Tonekabon Branch
City
tonekabon

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Science, vice chancellor for research(primary sponsor
Full name of responsible person
Dr. Akbar Fotuhi
Street address
khods street, keshavarz boulevard
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science, vice chancellor for research(primary sponsor
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
Tehran University of Medical Science
Full name of responsible person
Dr. Zahra Behboodi Moghadam
Position
PHD of Reproductive Health
Other areas of specialty/work
Street address
Tohid squar, School of Midwifery and Nursing
City
tehran
Postal code
Phone
+98 21 6105 4215
Fax
+98 912 249 4201
Email
behboodi@tums.ac.ir bahar_behboodi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Zahra Behboodi Moghadam
Position
PHD of Reproductive Health
Other areas of specialty/work
Street address
Tohid squar, School of Midwifery and Nursing
City
tehran
Postal code
Phone
+98 21 6105 4215
Fax
+98 21 6692 7171
Email
Behboodi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
faculty of nursing and midwifery of tehran university of medical sciense
Full name of responsible person
roghaye shiroodgholami
Position
student of Master of Midwifery
Other areas of specialty/work
Street address
dormitory of Islamic Azad University - Tonekabon Branch
City
tonekabon
Postal code
Phone
+98 19 2428 7645
Fax
Email
roghaye.shiroodgholami@yahoo.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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