The effect of tablet contain mixture of extract of Vitex agnus castus, Chamomile, Echium amoenum and vitamin B6 on symptoms of Premenstrual Syndrom (PMS)
This study will be performed as double-blind trial, randomized, placebo-controlled by calling on 100 females collegians of Medical Sciences of Kashan University who have premenstrual syndrome, regular menstrual cycle and no signs of systemic disease or mental and physical stress before and during the study based on standard questionnaire.
Before receiving drug or placebo, they will record daily symptoms for two months and after definitive diagnosis of PMS they will be divided randomly to two groups, receiveing daily tablet containing Vitex agnus castus, Chamomile, Echium amoenum extracts and Vitamin B6 or receiving placebo tablet for two months.
Tables of daily symptoms forms (physical and psychological symptoms) and DSM-IV questionnaire will be completed during this time and will be consider at the end of each month. Changes in both groups will compare to baseline and also relative to each other at the end of two months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060812438N13
Registration date:2015-07-22, 1394/04/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-22, 1394/04/31
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij essence pharmaceutical company
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tablet contain mixture of extract of Vitex agnus castus, Chamomile, Echium amoenum and vitamin B6 on symptoms of Premenstrual Syndrom (PMS)
Public title
The effect off Vitex agnus castus, Chamomile, Echium amoenum extracts and vitamin B6 on Premenstrual Syndrom of students from Kashan University of Medical Sciences
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: regular menses period; no pregnancy or lactation; no history of psychological disorders; no alcohol or tobacco use; no history of systemic disorder; no history of contraceptive use.
Exclusion Criteria: Chronic disorder; Pelvic Inflammatory Disease (PID); taking specific drug; having stress such as having infection; inflammation and psychological disorder.
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:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomization: table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Approval date
2015-03-04, 1393/12/13
Ethics committee reference number
29/51/1/6001/پ
Health conditions studied
1
Description of health condition studied
premenstural syndrom
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
severity of premenstural syndrom
Timepoint
Baseline and End of each months
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention :herbal tablet made in Barij essence pharmaceutical company contain mixture of extract of Vitex agnus castus, Chamomile, Echium amoenum and vitamin B6 ,daily,for 2 months
Category
Treatment - Drugs
2
Description
control : placebo tablet made in Barij essence pharmaceutical company contain Cellulose,daily.for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan University of Medical Science
Full name of responsible person
Fatemeh Abbaszadeh
Street address
School of Nursing and Midwifery,Qotbe Ravandi Boulevard, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Essence Company
Full name of responsible person
Mohsen Taghizadeh
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence Company
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
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
School of Medicine,Qotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Abbaszadeh
Position
Master of midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Qotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
abbaszadeh_F@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Mahnaz.Mahlouji
Position
Clinical Expert
Other areas of specialty/work
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Postal code
Phone
00
Fax
Email
mahnaz.mahlouji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)