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Comparison of Panjangosht (Vitex agnus-castus) and Maryamgoli (Salvia officinalis) effects on the serum lipids and Sexual Function in menopausal women

Protocol summary

Summary
Objectives: In this study, Cholesterol, low-density lipoprotein(LDL), high-density lipoprotein(HDL), triglycerides(TG), the thickness of the endometrial and sexual function before and after treatment in vitex and sage extract group compared with the control group. Design: In this double-blind study of 100 postmenopausal women referred to hospital BMD Namazee(single core) by permutation block divided into three groups and blinding The idea is that participants with the contacts did not have the help of researcher Tablets black codes and put in jars to the researcher does not know what a pill each canister. Setting and conduct: First, personal information forms and a Sexual Function Questionnaire and tests of serum lipids and Ultrasound endometrial thickness is performed and the above process is repeated after 3 months of intervention. Inclusion criteria: postmenopausal women who don`t use effective drugs on serum lipids and kinds of hormonal medicines. Interventions: the first intervention group is given, daily, one Agnugol tablets, 3.2- 4.8Mg(extract of VAC), the second group is given, daily, three Salvigol tablets, 100 Mg(Salvia officinalis extract), and the third group is given each day three placebo tablets.. Agnugol and Salvgl tablets are products Goldarou Company of Esfahan .main outcome:serum lipids –sexual function.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041613940N4
Registration date: 2016-04-26, 1395/02/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-04-26, 1395/02/07
Registrant information
Name
Marzieh Akbarzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
akbarzadm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice president of Research Shiraz university of medical sciences
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2016-08-05, 1395/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Panjangosht (Vitex agnus-castus) and Maryamgoli (Salvia officinalis) effects on the serum lipids and Sexual Function in menopausal women
Public title
effect of vitex and sage on serum lipids and sexual function in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :1) Menopausal women, 2) Women willing to cooperate in this study and presented their written consent form, 3) . They should not use effective drugs on serum lipids, 4)They should not use any kinds of hormonal medicines, 5) They should not be sensitive to herbal medicines. .Exclusion criteria:1) Allergic reaction to medicine, 2) Detection of a patient, during the study, who needs to use the medicine effective on serum lipids.
Age
No age limit
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
Block permutation methods

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shiraz university of madical sciences
Street address
Shiraz - zand street - next to the Red crescent- sakhtman central university
City
Shiraz
Postal code
71345-1978
Approval date
2016-03-16, 1394/12/26
Ethics committee reference number
IR.SUMS.REC.1394.209

Health conditions studied

1

Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
serum lipids
Timepoint
At the beginning and end of the study
Method of measurement
Blood test

Secondary outcomes

1

Description
Sexual function
Timepoint
At the beginning and end of the study
Method of measurement
Sexual Function Questionnaire(FSFI)

Intervention groups

1

Description
the first intervention group is given, daily, one Agnugol tablets, 3.2- 4.8 Mg for 3 monthes( product Goldarou Company of Esfahan)
Category
Treatment - Drugs

2

Description
the second intervention group is given, daily, three Salvigol tablets, 100 Mg for 3 monthes ( product of Goldarou Company of Esfahan)
Category
Treatment - Drugs

3

Description
In control group is given each daily three placebo tablets for 3 monthes
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazee hospital
Full name of responsible person
Mohammadali tadayon
Street address
Shiraz-Namazee hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President of Research Shiraz University of Medical Sciences
Full name of responsible person
Dr.Masum masumpur
Street address
Shiraz - Zand Street - Next to the Red Crescent - Sakhtmtn Central University - Class 7 - Research
City
shiraz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
marzieh akbarzadeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
shiraz
Postal code
71345-1978
Phone
00
Fax
-
Email
akbarzadm@sums.ac.ir
Web page address
www.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
marzieh akbarzadeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
shiraz
Postal code
71345-1978
Phone
+98 71 3425 6647
Fax
-
Email
akbarzadm@sums.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
afsaneh zeidabadi nejad
Position
student Master of Midwifery
Other areas of specialty/work
Street address
Bandar abbas-south resalat
City
Bandar abbas
Postal code
7916843159
Phone
+98 67 3771 7368
Fax
-
Email
afsanehzeidabadi@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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