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IRCT20190726044339N4 IRCT 2023-03-03 Shiraz University of Medical Sciences Investigating the effect of lavender on depression in patients with multiple sclerosis Comparison of the effectiveness of lavender capsules (linazepam) with placebo in improving depression symptoms in patients with multiple sclerosis 2023-02-20 anticipated 60 Complete https://irct.ir/trial/68643 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The researcher enrolls participants based on the convenience sampling method. NCSS software (Number Cruncher Statistical System) and block randomization are used for randomizing the study. In the block randomization method, participants are categorized into 6 blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB), with each block containing 4 participants. In this study, "A" is assigned to the drug group and "B" to the placebo group. For example, in the "ABAB" block, the first person enters the drug group, the second person enters the placebo group, the third person enters the drug group, and the fourth person enters the placebo group. Thus, all eligible participants are randomly assigned to one of the study arms according to the randomization list, Blinding description: Physicians, patients, and drug deliverer will blind to the allocation of intervention. It should be noted that the drugs' containers is the same. Additionally, placebo capsule is similar to lavender capsule regarding the color and shape. 3 Multiple Sclerosis. Intervention 1: Intervention Group: Participants in this group will be prescribed one capsule of linazepam, which contains lavender essence, one hour before bedtime for eight weeks at night. This linazepam capsule is a pharmaceutical product available in the market and was purchased from Arum Teb Daro Pharmaceutical Company. Additionally, patients in this group will receive routine treatment for depression, which includes one tablet of sertraline (Abidi-Tehran Pharmaceutical Company, Tehran, Iran) 100 mg per day. Intervention 2: Control group: Participants in this group will be prescribed one placebo capsule one hour before bedtime for eight weeks at night.The placebo capsule is made by the co-pharmacist of the project at the Faculty of Pharmacy of Shiraz University of Medical Sciences.Also, patients in this group receive routine treatment for depression (one sertraline tablet 100 mg per day). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Sara Dehbozorgi
Namazi square
Shiraz Iran (Islamic Republic of) 7654971466 +98 71 3228 7237 dehbozorgis@sums.ac.ir Shiraz University of Medical Sciences scientific Sara Dehbozorgi
Namazi square
Shiraz Iran (Islamic Republic of) 7654971466 +98 71 3228 7237 dehbozorgis@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Men and women with Relapsing-remitting multiple sclerosis patients with aged between ۱۸-۵۰ years Score above ۱۱ according to Persian- version of the Beck Depression Inventory-II (BDI-II-Persian) 18 years 50 years Both Pregnancy and breastfeeding Allergy to lavender Unstable heart, kidney and liver patients Seizures Hypothyroidism Consumption of alcohol or drugs Patients who do not follow the study completely Patients with severe depression Treatment - Drugs Placebo Intervention Group: Participants in this group will be prescribed one capsule of linazepam, which contains lavender essence, one hour before bedtime for eight weeks at night. This linazepam capsule is a pharmaceutical product available in the market and was purchased from Arum Teb Daro Pharmaceutical Company. Additionally, patients in this group will receive routine treatment for depression, which includes one tablet of sertraline (Abidi-Tehran Pharmaceutical Company, Tehran, Iran) 100 mg per day. Control group: Participants in this group will be prescribed one placebo capsule one hour before bedtime for eight weeks at night.The placebo capsule is made by the co-pharmacist of the project at the Faculty of Pharmacy of Shiraz University of Medical Sciences.Also, patients in this group receive routine treatment for depression (one sertraline tablet 100 mg per day). Change in Beck questionnaire score. Timepoint: Measurement of depression severity at the beginning of the study (before the start of the intervention) and 4, 8 weeks after the start of taking the drug or placebo. Method of measurement: Depression Beck questionnaire. Shiraz University of Medical Sciences Approved 2022-08-27 Shiraz University of Medical Sciences Namazi Square, Imam Reza Clinicا Shiraz Fars Iran (Islamic Republic of)