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On the consideration and comparison of Panjangosht (Vitex agnus-castus) and Maryamgoli (Salvia officinalis) effects on the osteogenic factors and physical and emotional symptoms in menopausal women

Protocol summary

Summary
Objectives: In this study, alkaline phosphatase, osteocalcin, carboxy-terminal telopeptides of type I collagen, calcium, phosphorus, vitamin D, physical and psychological symptoms 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 questionnaire about Menopause Rating Scale (MRS) and tests of osteogenic factors is performed and the above process is repeated after 3 months of intervention. Inclusion criteria: are osteopenic postmenopausal women who received calcium and vitamin D supplementation but do not receive other effective drugs on bone density. 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: osteogenic factors - physical and mental symptoms.

General information

Acronym
comparison of Panjangosht and Maryamgoli effects on the osteogenic factors and physical and
IRCT registration information
IRCT registration number: IRCT2015111713940N2
Registration date: 2016-04-26, 1395/02/07
Registration timing: registered_while_recruiting

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 chancellor for research Shiraz University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
On the consideration and comparison of Panjangosht (Vitex agnus-castus) and Maryamgoli (Salvia officinalis) effects on the osteogenic factors and physical and emotional symptoms in menopausal women
Public title
effect vitex and sage on osteogenic factors and physical and emotional symptoms 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) These women should not suffer from diseases related to liver, kidney, thyroid, parathyroid, intestine and bone…… in which they receive special medicines which affect the bone density, 4)They should not use any kinds of hormonal medicines, 5) Menopausal women who are osteopanic and receive supplementary Calcium and vitamin D, but they do not receive treatment with other with other effective hormonal medicines which affect the bone density (these medicines are mostly used by osteoprose patients), 6) 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 bone density.
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 Medical Sciences
Street address
Shiraz - Zand Street - Next to the Red Crescent - Sakhtmtn Central University - Class 7 - Research
City
Shiraz
Postal code
1978 -71345
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
IR.SUMS.REC.1394.185

Health conditions studied

1

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

2

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

Primary outcomes

1

Description
osteogenic factors
Timepoint
At the beginning and end of the study
Method of measurement
Blood test

Secondary outcomes

1

Description
physical and emotional symptoms
Timepoint
At the beginning and end of the study
Method of measurement
the questionnaire about Menopause Rating Scale(MRS)

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
+98 71 3234 1344
Fax
-
Email
akbarzadm@sums.ac.ir
Web page address
-

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 76 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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