Evaluation of the effect of Lavandula Angustifolia, Echium amoenum, and Melissa officinalis in comparison with sertraline in the treatment of mild to moderate depression in older adults: A triple-blind randomized controlled trial

Determining the effect of Lavander, Echium amoenum, and Melissa in comparison with sertraline in the treatment of mild to moderate depression in older adults

A triple-blind randomized clinical trial with four groups: Lavandula and Melissa, Melissa and Echium amoenum, Lavandula and Echium amoenum, and sertraline.

Patients will be randomly divided into four groups: Lavandula and Melissa, Melissa and Echium amoenum, Lavandula and Echium amoenum, and sertraline. The study is triple-blind (researchers, participants, and outcome evaluators will not be aware of the groups involved).

Inclusion criteria: Age over 60 years, mild to moderate depression (depression score of 18 to 24 in the Hamilton questionnaire). Exclusion criteria: no use of antidepressants and antipsychotics and mood-stabilizing nutrients four weeks before the clinical trial, suicidal ideation, symptoms of major depression, alcohol use in the past 12 months, warfarin and phenytoin, people who have just started psychotherapy, Pregnancy, and lactation, taking birth control pills, substance abuse, head trauma, hypothyroidism, and dementia, bipolar spectrum, psychoses, receiving ECT

Lavandula and Melissa group will receive 1 capsule 250mg Lavandula (1g) and Melissa (1g), Melissa and Echium amoenum group will receive 1 capsule 250mg Melissa (1g) and Echium amoenum (500mg), Lavandula and Echium amoenum group will receive 1 capsule 250mg Lavandula (1g) and Echium amoenum (500mg), and sertraline group will receive 1 capsule 250mg containing 12.5 mg sertraline for first 10 days and 50 mg in next 46 days, every 12 hours for 8 weeks.

The rate of depression measured by the Hamilton Questionnaire in the first, second, fourth, and eighth weeks.

Samples will be randomly assigned to 8 blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment). The sample allocation ratio will be Allocation 1:1 and will be divided into 4 groups of Lavandula Angustifolia and Melissa officinalis, Melissa Officinalis and Echium amoenum, Lavandula Angustifolia and Echium amoenum, and finally sertraline. In the next step, each client will receive white envelopes that are prepared in equal sizes and on which group .. drugs (for the first 10 days of study) and group ... drugs (for the next 46 days) are written. Also, each envelope will be numbered from 1 to 120 (in the order to allocation sequence). Groups ... and ... will have different contents only in the group of patients who will receive sertraline so that group .. contains 12.5 mg sertraline and group ... contains 50 mg of sertraline. Only the person in charge of packing drugs will know the numbers of the relevant pockets and none of the researchers or patients will know the type of medicine that each person receives. The first person will be given pocket number 1 and then it will continue until completion. Lavandula Angustifolia and Melissa officinalis, Melissa Officinalis and Echium amoenum, Lavandula Angustifolia and Echium amoenum, and sertraline capsules will be similar in shape, size, color and, smell.

Based on blocks and allocation sequences each client will be given white pockets that are prepared in equal sizes and on which the numbers 1 to120 are written (in order of allocation sequence). The pockets will contain white boxes containing Lavandula Angustifolia and Melissa officinalis, Melissa Officinalis and Echium amoenum, Lavandula Angustifolia and Echium amoenum, and sertraline capsules. Only the person in charge of packing Lavandula Angustifolia and Melissa officinalis, Melissa Officinalis and Echium amoenum, Lavandula Angustifolia and Echium amoenum, and sertraline capsules will know the numbers of the relevant pockets and none of the researchers, patients, or outcome evaluators will know the type of medicine that each person receives. The first person will be given pocket number 1 and then it will continue until completion. All capsules will be similar in shape, size, color, and smell.

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