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IRCT20260523069501N1 IRCT 2026-07-22 Ahvaz University of Medical Sciences Studying the effect of Rosmarinus officinalis L infusion on stress, anexiaty and depression in menopausal women Studying the effect of Rosmarinus officinalis L infusion on stress, anexiaty and depression in menopausal women 2026-07-23 anticipated 108 Recruiting https://irct.ir/trial/90400 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Supportive, Randomization description: Using a simple random sampling method, people are divided into two intervention groups (rosemary tea, 54 people) and control (placebo tea containing wheat bran, 54 people). The allocation of people to each of the two groups is done using a simple randomization method, so that a number is randomly selected for each person with the help of a random number table, if the selected number ends in 0 to 4, that person is assigned to the first group (intervention), and if it ends to 5 to 9, that person is assigned to the second group (control). Allocation of people to each of the groups is done in such a way that participants and researchers are unaware of the group assigned to the patient (double blind).It should be noted that tea bags are placed in cardboard envelopes in packs of 28 so that their contents are unclear. Also, the method of distribution is such that the participants receive a 28-pack at the beginning of the study period. At the end of the fourth week, they go to the health center to complete the questionnaire again and receive the second 28-pack, Blinding description: In order to ensure impartiality in evaluating the effects of the intervention, the blinding process was implemented in two ways. In this regard, all study participants were unaware of the type of intervention they were receiving (rosemary tea or placebo). Also, the research executive team, including clinical assessors, data collectors, and other people who interacted directly with the participants, were not aware of the allocation of people to the intervention and control groups.In order to maintain this blinding situation, the rosemary tea and the placebo were designed and prepared in such a way that no distinction between them could be distinguished in terms of appearance and packaging. The responsibility of assigning the codes related to the intervention and placebo groups remained confidentially with a third party (such as a statistician or an independent pharmacist) to avoid any possible bias during the implementation and data collection process. N/A Menopause. Intervention 1: The intervention group consists of menopausal women with moderate to mild levels of stress, anxiety, and depression as measured by the DASS-21 questionnaire; these participants will consume a rosemary infusion (2.5 g of dried rosemary leaves in 150 mL of boiling water) for 8 weeks, with DASS-21 scores being assessed at baseline (two sessions prior to the intervention), at 4 weeks, and at 8 weeks post-intervention. Intervention 2: Control Group:The control group consists of menopausal women with moderate to mild levels of stress, anxiety, and depression as measured by the DASS-21 questionnaire; these participants will consume a wheat bran infusion (2.5 g of wheat bran powder in 150 mL of boiling water) for 8 weeks, with DASS-21 scores being assessed at baseline (two sessions prior to the intervention), at 4 weeks, and at 8 weeks post-intervention. Yes - There is a plan to make this available What will be shared: The available data will consist of anonymized clinical datasets, including patient demographic characteristics (age, gender), baseline characteristics, clinical outcomes, depression, anxiety, and stress scores, as well as relevant diagnostic findings. All personally identifiable information (PII) will be strictly removed to ensure participant confidentiality. Documentation may include the study protocol and the statistical analysis plan. When: The data access period will commence 8 months after the publication of the study To whom: Data access will be restricted to researchers affiliated with academic or scientific institutions. Conditions: De-identified data may be available to qualified researchers upon reasonable request and after approval from the corresponding author, solely for the purpose of scientific validation or further research. Access will be granted provided that such requests comply with ethical guidelines and patient confidentiality Where to obtain: Requests for data or related documentation should be directed to the corresponding author via the email address provided in the study publication or registration details. How to obtain: The process involves the following steps: 1) The requesting researcher submits a formal written request to the corresponding author, including a detailed research protocol and the intended use of the data. 2) The research team reviews the request for scientific merit and alignment with the original study’s objectives. 3) Upon scientific approval, the request is reviewed to ensure it complies with ethical guidelines and data privacy regulations. 4) Once approved, a Data Use Agreement (DUA) may be signed, and de-identified data will be shared via a secure method. Comments:
public Mahdis Bigdeli
No. 38, 2nd Street., Iman Blvd., Sepidar
Ahwaz Iran (Islamic Republic of) 6177634848 +98 61 3229 0604 bigdelisanam79@gmail.com Ahvaz University of Medical Sciences scientific Mahdis Bigdeli
No. 38, 2nd Street., Iman Blvd., Sepidar
Ahvaz Iran (Islamic Republic of) 6177634848 +98 61 3229 0604 bigdelisanam79@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Menopause (at least 12 months have passed since the last menstrual period) mild to moderate symptoms of stress, anxiety and depression (according to the DASS scale score) Literacy of at least a diploma 50 years 60 years Female Having an allergy to rosemary Addiction and use of antidepressants The occurrence of a disease or an accident or an event that causes problems with the consumption of rosemary in a person. Consuming any herbal tea with the same effective ingredient as rosemary. For example: lavender. Chamomile Basil leaves, saffron, lemon balm... Having any chronic and physical illness The occurrence of stressful events such as the death of relatives, etc. in the last 6 months People under hormone therapy N95.1 Menopausal and female climacteric states Treatment - Other Treatment - Other The intervention group consists of menopausal women with moderate to mild levels of stress, anxiety, and depression as measured by the DASS-21 questionnaire; these participants will consume a rosemary infusion (2.5 g of dried rosemary leaves in 150 mL of boiling water) for 8 weeks, with DASS-21 scores being assessed at baseline (two sessions prior to the intervention), at 4 weeks, and at 8 weeks post-intervention Control Group:The control group consists of menopausal women with moderate to mild levels of stress, anxiety, and depression as measured by the DASS-21 questionnaire; these participants will consume a wheat bran infusion (2.5 g of wheat bran powder in 150 mL of boiling water) for 8 weeks, with DASS-21 scores being assessed at baseline (two sessions prior to the intervention), at 4 weeks, and at 8 weeks post-intervention. Depression. Timepoint: Checking the depression score according to the DASS-21 questionnaire at the beginning of the study (before the start of the intervention) and 4, 8 weeks after the consumption of rosemary tea. Method of measurement: Questionnaire DASS-21. Anxiety. Timepoint: Checking the anxiety score according to the DASS-21 questionnaire at the beginning of the study (before the start of the intervention) and 4, 8 weeks after the consumption of rosemary tea. Method of measurement: Questionnaire DASS-21. Stress. Timepoint: Checking the stress score according to the DASS-21 questionnaire at the beginning of the study (before the start of the intervention) and 4, 8 weeks after the consumption of rosemary tea. Method of measurement: Questionnaire DASS-21. Ahvaz University of Medical Sciences Approved 2026-06-27 Jundishapur University of AJUMS Medical Sciences Shahrivar Street, Golestan Boulevard Ahvaz Khouzestan Iran (Islamic Republic of)