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Effect of Salvia officinalis Tablet on lipid profile and quality of life in postmenopausal women

Protocol summary

Study aim
The effect of sage on serum lipids and quality of life in postmenopausal women
Design
Clinical trial with control group, with parallel groups, double-blind, randomized by permutation method
Settings and conduct
The researcher-made demographic information questionnaire and the quality of life questionnaire of postmenopausal women are completed by the researcher. The samples are controlled for serum lipids, including cholesterol, triglycerides, LDL and HDL. They are then intervened with medication or placebo for 8 weeks. The intervention is in the form of oral tablets of 100 mg of sage extract or placebo three times a day. At the end of 8 weeks, the questionnaire of quality of life of postmenopausal women is completed again by the researcher and the tests are repeated, and the results are compared and statistically analyzed. Will be located.The study site is health centers in Shiraz.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Menopausal women between the ages of 45-60, without any serious physical or mental illness, without any use of hormonal drugs, with body mass index less than 29, no smoking, no allergies. Exclusion criteria: use of hormonal drugs, beta-blocker, thiazide, allergy, use of any drug that affects menopause, blood lipid level more than 300mg
Intervention groups
After obtaining informed consent and providing the necessary explanations, 100 mg oral sage extract tablets were prescribed daily for the intervention group and placebo for the control group.
Main outcome variables
Quality of life, serum lipids

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140622018187N12
Registration date: 2020-08-17, 1399/05/27
Registration timing: retrospective

Last update: 2020-08-17, 1399/05/27
Update count: 0
Registration date
2020-08-17, 1399/05/27
Registrant information
Name
Sedighe Forouhari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 987136474257
Email address
foruharis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Shiraz University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
2014-05-22, 1393/03/01
Actual recruitment end date
2014-06-22, 1393/04/01
Trial completion date
2014-06-22, 1393/04/01
Scientific title
Effect of Salvia officinalis Tablet on lipid profile and quality of life in postmenopausal women
Public title
The effect of Salvia officinalis on lipid profile and quality of life in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 45 and 60 years Menstruation in the past year Conscious written consent No known physical or mental illness Do not take any hormonal medications to reduce menopausal symptoms in the past month Do not take lipid-lowering drugs BMI below 29 No history of allergy to herbal medicines No smoking, hookah or drug addiction
Exclusion criteria:
Age
From 45 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 102
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The population of eligible women is randomly assigned to two groups using a random permutation block design. The groups are placed and if the numbers 5 to 9 are observed, two people are placed in two groups as BA permutations and we repeat this until we have 51 people in each group. Thus, the samples are divided into two groups A (drug group A) and group B (group consuming drug B) are divided. Women are also informed that they will be accidentally placed in one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study and the patient and the researcher are not aware of receiving sage and placebo, and both are prepared by the Faculty of Pharmacy and will be provided to the patient with a code. After completing the research, the type of intervention will be determined with codes.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Shiraz University of Medical Sciences
Street address
Research Deputy, Shiraz University of Medical Science shiraz
City
Shiraz
Province
Fars
Postal code
1978-71345
Approval date
2014-03-19, 1392/12/28
Ethics committee reference number
93-01-50-7632

Health conditions studied

1

Description of health condition studied
Menopausal and femal climacteric state
ICD-10 code
N95.1
ICD-10 code description
Menopausal and other perimenopausal disorders

Primary outcomes

1

Description
cholesterol
Timepoint
1 week before the intervention and 8 weeks after intervention
Method of measurement
Laboratory

2

Description
Triglycerides
Timepoint
1 week before the intervention and 8 weeks after intervention
Method of measurement
Laboratory

3

Description
HDL
Timepoint
1 week before the intervention and 8 weeks after intervention
Method of measurement
Laboratory

4

Description
LDL
Timepoint
1 week before the intervention and 8 weeks after intervention
Method of measurement
Laboratory

Secondary outcomes

1

Description
Menopause Quality Of Life
Timepoint
1 week before the intervention and 8 weeks after intervention
Method of measurement
Menopause Quality Of Life Questionnaire

Intervention groups

1

Description
Salvia officinalis extract, 100 mg tablet, three times daily for 8 weeks.
Category
Treatment - Drugs

2

Description
Placebo, tablets 100 mg, three times daily, 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Clinic in Shiraz, Namazi Square, Shiraz
Full name of responsible person
Sedighe Foruhari
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 1647 4257
Email
forouharism@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Technology and Research Office, Research Deputy , Shiraz University of Medical Science, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
president@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Forouhari
Position
Ph.D , Supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3647 4257
Fax
Email
forouharism@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Forouhari
Position
Ph.D , Supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3647 4257
Fax
Email
foruharis@sums.ac
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Foruhari
Position
Ph.D , Supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 1647 4257
Fax
Email
forouharism@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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