Protocol summary

Study aim
Determination the effect of palm pollen on menopausal symptoms of women covered by Rafsanjan Comprehensive Health Care Centers year 1398
Design
A randomized controlled clinical trial with parallel groups, three blinded, randomized
Settings and conduct
The researcher, after approving the project in the Research Council of Rafsanjan University of Medical Sciences and obtaining the code of ethics and obtaining the necessary authorization to conduct research from the university, will refer to the midwifery units.Thus postmenopausal women are screened for entry requirements and if eligible, explaining the purpose of the study, they are invited to participate in the project and they will enter the study with written consent. Individuals will be assigned to the intervention and control groups randomly and It will be by lottery. The intervention group will be given 30 palm pollen capsules and the control group the same number of placebo capsules for one month, one capsule daily.The participants, the researcher, the data collector, and the statistical consultant are unaware of the type of medicine and the study will be three-blind.
Participants/Inclusion and exclusion criteria
Inclusion in the study: Age between 50 and 65 years At least 12 months or more since the last menstrual period Exclusion from the study: breast and uterine cancers, abnormal vaginal bleeding, depression or known mental disorders use of progestin hormone pills, contraceptive pills, agonists and gonadotropin releasing hormone antagonists, taking other herbal remedies regularly, liver, kidney and thyroid diseases
Intervention groups
The intervention group received palm pollen capsules for 4 weeks at a daily dose of 300 mg and the control group received placebo capsules similar to the intervention capsules filled with starch for 4 weeks.
Main outcome variables
The status of menopausal symptoms with palm pollen capsules

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160308026971N6
Registration date: 2020-01-03, 1398/10/13
Registration timing: registered_while_recruiting

Last update: 2020-01-03, 1398/10/13
Update count: 0
Registration date
2020-01-03, 1398/10/13
Registrant information
Name
Marzeyeh Loripoor
Name of organization / entity
Rafsanjan University Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 4950
Email address
m.loripoor@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of date palm pollen on menopausal symptoms in women affiliated by Comprehensive Health Services Centers in Rafsanjan ,2019
Public title
Investigating the effect of date palm pollen on menopausal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 65-50 years At least 12 months or more since the last menstrual period Informed and free consent to participate in the study
Exclusion criteria:
breast and uterine cancers, abnormal vaginal bleeding, depression or known mental disorders Use of any herbal remedies Abnormal vaginal bleeding Known diseases of the liver, kidney and thyroid Taking any hormone or non-hormonal drug use of progestin hormone pills, contraceptive pills, agonists and antagonists gonadotropin releasing hormone
Age
From 50 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation to the intervention and control groups is random and will be by lottery. Put 55 sheets of code 1 and 55 of code 2 , in a container and stir. We ask each participant to remove one of the sheets from the container and randomly fall into one of the capsule consumption groups with code 1 or code 2.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Drug maker packs palm pollen and placebo capsules with codes 1 and 2 and is provided to postmenopausal women by a researcher or data collector.The questionnaires will be marked with codes 1 and 2, then the completed questionnaires are submitted to the statistical consultant for analysis.thus, the women participating in the project, the researcher, the data collector, and the statistical advisor of the type of drug will be unaware and the study will be three-blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Committee on Ethics in Biomedical Research
Street address
Imam Ali Boulevard, Central Organization of Rafsanjan University of Medical Sciences, Vice Chancellor for Research,
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2019-11-11, 1398/08/20
Ethics committee reference number
IR.RUMS.REC.1398.142

Health conditions studied

1

Description of health condition studied
Symptoms of Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
Symptoms of Menopause
Timepoint
Before intervention, End of intervention, 4 weeks after intervention
Method of measurement
Based on MRS questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Use 30 capsules of palm pollen at a dose of 300 mg daily for one month
Category
Treatment - Drugs

2

Description
Control group: Take 30 placebo capsules at a dose of 300 mg daily for one month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Health Service Centers
Full name of responsible person
Fatemeh Esmaeili
Street address
Shohada Ave.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 9040
Email
info@rums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Esmaeili
Street address
Imam Ali Blvd., Dept. of Research & Technology,Central Office of Rafsanjan University of Medical Sciences,
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
alishamsy@gmail.com
Web page address
http://vcrt.rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Nursing street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0035
Fax
+98 34 3425 8497
Email
marzeyehloripoor@yahoo.com

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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