Protocol summary
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Study aim
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To assess the effect of green basil (Ocimum basilicum) leaf powder versus placebo on menopausal rating scale and sleep quality in postmenopausal women
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Primary outcome:
Sleep quality
Menopause symptoms
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2024-11-28, 1403/09/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-12-21, 1403/10/01
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Expected recruitment end date
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2025-03-05, 1403/12/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Effect of green basil (Ocimum basilicum) leaf powder versus placebo on menopausal rating scale and sleep quality in postmenopausal women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 44 years old to 55 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-11-02, 1403/08/12
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Ethics committee reference number
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IR.UMSHA.REC.1403.550
Health conditions studied
1
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Description of health condition studied
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Perimenopausal disorders
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ICD-10 code
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N95
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ICD-10 code description
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Menopausal and other perimenopausal disorders
Primary outcomes
1
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Description
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Sleep quality
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Timepoint
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Before intervention and 28 days later
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Method of measurement
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Using the Pittsburgh Sleep Quality Questionnaire
2
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Description
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Menopause symptoms
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Timepoint
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Before intervention and 28 days later
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Method of measurement
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Using the Menopause Rating Scale (MRS)
Intervention groups
1
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Description
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Intervention group: Routine menopausal care plus capsules containing green basil powder 450 mg twice daily for 28 days
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Category
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Treatment - Drugs
2
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Description
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Control group:Routine menopausal care plus capsules containing placebo (starch) twice daily for 28 days
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available