Studying the effect of Rosmarinus officinalis L infusion on stress, anexiaty and depression in menopausal women

Determining the effect of rosemary tea on estress, anxiety and depression in postmenopausal women

This study is a randomized placebo-controlled trial. Randomization of 108 participants will be conducted via simple randomization using a random number table. Participants will be allocated to groups based on the final digit of their assigned random number: digits from 0 to 4 will designate the intervention group, while digits from 5 to 9 will designate the control group. The study will employ a double-blind design.

This double-blind study will be conducted on 108 menopausal women referring to the 17 shahrivar Health Center and Health Center No. 4 in Ahvaz. Participants with specific scores for depression, anxiety, and stress (based on DASS-21) will be selected and randomly divided into an intervention group (rosemary tea, 54 people) and a control group (wheat bran placebo tea, 54 people). Questionnaires will be completed before the intervention, and 4 and 8 weeks after. Both groups will consume one tea bag (2.5 grams) daily for 8 weeks, with identical packaging and appearance of the teas to maintain blinding. Participants will record consumption information and physical status. Potential side effects will be followed up.

Inclusion Criteria: Age: 50–60 years; Postmenopausal status (≥12 months amenorrhea); Mild-to-moderate stress, anxiety, and depression (via DASS scale); Minimum high school diploma. Exclusion Criteria: Rosemary hypersensitivity; Substance abuse or antidepressant use; Chronic physical illnesses; Current hormone therapy.

The intervention group consumes rosemary tea daily for 8 weeks and the control group consumes wheat bran placebo tea; Both groups have similar packaging and appearance to maintain blinding

Reducing anxiety; reducing depression; Reduce stress

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.

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.

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.

The data access period will commence 8 months after the publication of the study

Data access will be restricted to researchers affiliated with academic or scientific institutions.

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

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.

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.