Effect of green basil (Ocimum basilicum) leaf powder versus placebo on menopausal rating scale and sleep quality in postmenopausal women: a triple-blind randomized clinical trial
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Protocol summary
Intervention group:
Routine menopausal care plus capsules containing green basil powder 500 mg twice daily for 28 days
Control group:
Routine menopausal care plus capsules containing placebo (starch) twice daily for 28 days
Intervention group:
Routine menopausal care plus capsules containing green basil powder 450 mg twice daily for 28 days
Control group:
Routine menopausal care plus capsules containing placebo (starch) twice daily for 28 days
Intervention group: Routine menopausal care plus capsules containing green basil powder 500450 mg twice daily for 28 days Control group: Routine menopausal care plus capsules containing placebo (starch) twice daily for 28 days
گروه مداخله:
مراقبتهای روتین دوران یائسگی بعلاوه کپسول حاوی پودر ریحان سبز 5۰۰ میلی گرم روزی دو بار به مدت 28 روز
گروه کنترل:
مراقبتهای روتین دوران یائسگی بعلاوه کپسول حاوی دارونما (نشاسته) روزی دو بار به مدت 28 روز
گروه مداخله:
مراقبتهای روتین دوران یائسگی بعلاوه کپسول حاوی پودر ریحان سبز 450 میلی گرم روزی دو بار به مدت 28 روز
گروه کنترل:
مراقبتهای روتین دوران یائسگی بعلاوه کپسول حاوی دارونما (نشاسته) روزی دو بار به مدت 28 روز
گروه مداخله: مراقبتهای روتین دوران یائسگی بعلاوه کپسول حاوی پودر ریحان سبز 5۰۰450 میلی گرم روزی دو بار به مدت 28 روز گروه کنترل: مراقبتهای روتین دوران یائسگی بعلاوه کپسول حاوی دارونما (نشاسته) روزی دو بار به مدت 28 روز
Intervention groups
#1
Intervention group: Routine menopausal care plus capsules containing green basil powder 500 mg twice daily for 28 days
Intervention group: Routine menopausal care plus capsules containing green basil powder 450 mg twice daily for 28 days
Intervention group: Routine menopausal care plus capsules containing green basil powder 500450 mg twice daily for 28 days
گروه مداخله: مراقبتهای روتین دوران یائسگی بعلاوه کپسول حاوی پودر ریحان سبز 5۰۰ میلی گرم روزی دو بار به مدت 28 روز
گروه مداخله: مراقبتهای روتین دوران یائسگی بعلاوه کپسول حاوی پودر ریحان سبز 450 میلی گرم روزی دو بار به مدت 28 روز
گروه مداخله: مراقبتهای روتین دوران یائسگی بعلاوه کپسول حاوی پودر ریحان سبز 5۰۰450 میلی گرم روزی دو بار به مدت 28 روز
Protocol summary
Study aim
To assess the effect of green basil (Ocimum basilicum) leaf powder versus placebo on menopausal rating scale and sleep quality in postmenopausal women
Design
This is a Phase III triple-blind randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using computer.
Settings and conduct
This study will be conducted at the Comprehensive Health Centers in Hamadan city, involving 76 eligible postmenopausal women. The patients will be randomly assigned to the intervention and control groups using computer. This trial will be triple-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 45 to 55 years
At least 1 to 5 years after menopause
Poor sleep quality
Exclusion criteria:
Smoking or alcohol use
Hormone therapy
Use of sedatives or sleeping pills
Intervention groups
Intervention group:
Routine menopausal care plus capsules containing green basil powder 450 mg twice daily for 28 days
Control group:
Routine menopausal care plus capsules containing placebo (starch) twice daily for 28 days
Main outcome variables
Primary outcome:
Sleep quality
Menopause symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N542
Registration date:2024-11-28, 1403/09/08
Registration timing:prospective
Last update:2024-12-27, 1403/10/07
Update count:1
Registration date
2024-11-28, 1403/09/08
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-03-05, 1403/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of green basil (Ocimum basilicum) leaf powder versus placebo on menopausal rating scale and sleep quality in postmenopausal women: a triple-blind randomized clinical trial
Public title
Effect of green basil (Ocimum basilicum) leaf powder versus placebo on menopausal rating scale and sleep quality in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45 to 55 years
At least 1 to 5 years after menopause
Poor sleep quality
Exclusion criteria:
Smoking or alcohol use
Hormone therapy
Use of sedatives or sleeping pills
Age
From 44 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to intervention and control groups using computer generated numbers. For this purpose, we receive a number from the computer when each patient visits, if the number is odd, the patient is assigned to the intervention group, and if the number is even, to the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. The analyzer responsible for evaluating the trial's results will also be kept blind to the type of interventions. Therefore, the trial will be conducted as a triple-blind study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2024-11-02, 1403/08/12
Ethics committee reference number
IR.UMSHA.REC.1403.550
Health conditions studied
1
Description of health condition studied
Perimenopausal disorders
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Sleep quality
Timepoint
Before intervention and 28 days later
Method of measurement
Using the Pittsburgh Sleep Quality Questionnaire
2
Description
Menopause symptoms
Timepoint
Before intervention and 28 days later
Method of measurement
Using the Menopause Rating Scale (MRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine menopausal care plus capsules containing green basil powder 450 mg twice daily for 28 days
Category
Treatment - Drugs
2
Description
Control group:Routine menopausal care plus capsules containing placebo (starch) twice daily for 28 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan city
Full name of responsible person
Nastaran Barati
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Barati_nb@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nastaran Barati
Position
Biotechnology Student
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Barati_nb@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nastaran Barati
Position
Biotechnology Student
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Barati_nb@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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