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IRCT20100127003210N26 IRCT 2022-10-28 Shahid Beheshti University of Medical Sciences The effect of L-arginine on sexual function and depression Evaluating the effect of L-arginine on sexual function in women with depression 2022-09-06 anticipated 40 Complete https://irct.ir/trial/62483 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization. Patients are divided into 10 blocks of 4 individuals, and different interventions are performed for patients based on the type of group (placebo or intervention). Each category will be assigned a code, and based on that code, the medicine or placebo code will be presented to the participants, and the performer is unaware of the code assigned to the medicine or placebo. In this method, Sealed Envelope software with the following internet address is used. This site is a free site for randomization in clinical trials. https://www.sealedenvelope.com/, Blinding description: Placebo and L-arginine are prescribed to the patient in similar opaque containers by the clinical caregiver participating in the study. Placebo and L-arginine containers have been coded by the principal investigator prior to drug administration. The patient and clinical caregiver participating in the study do not know the type of compounds in the containers, as well as the codes assigned to placebo and L-arginine. 3 Condition 1: Women's sexual function. Condition 2: Depression. Intervention 1: Intervention group: receiving L-arginine tablets (produced by Jalinous Pharmaceutical Company) 2 grams per day for 8 weeks. Intervention 2: Placebo group: receiving placebo tablets (produced by Jalinous Pharmaceutical Company) for 8 weeks. Yes - There is a plan to make this available What will be shared: Therapeutic findings of the intervention can be shared by statistical analysis without providing patient names. When: Start 6 months after publication To whom: Physicians and other researchers involved in studies on sexual function and depression. Conditions: People such as hospital staff or other medical staff such as nurses and clinical pharmacists can use this information. Where to obtain: Researchers can contact us via email at: pouriatorkamanofficial@gmail.com. How to obtain: People who intend to use the information must be affiliated with reliable organizations and their requests should be submitted through these organizations. In this context, there is a need for an introduction letter from the desired center. Comments:
public Maria Tavakoli Ardakani
Shahid Beheshti School of Pharmacy, Niayesh Highway, Valiasr Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1469658843 +98 21 8887 3704 Mariatavakoli@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr. Maria Tavakoli Ardakani
Valiasr St, Hashemi Rafsanjani Highway , Shahid Beheshti School of Pharmacy.
Tehran Iran (Islamic Republic of) 1469658843 +98 21 8887 3704 Mariatavakoli@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients in the age group of 18-60 years. Patients are referred to the psychiatric clinic of Taleqani Hospital and Imam Hossein Hospital. Patients who are diagnosed with major depressive disorder by the DSM-5 diagnostic criteria. Patients who have the consent to enter the study and complete the consent form. Patients who have not had a history of taking an antidepressant in the past month before starting current medications. Patients who do not have autonomic disorders in the genital tract. Patients who can take oral medications and also likely to complete evaluations. Patients without active ulcers in the gastrointestinal tract. People entering the study must be married during the study period. 18 years 60 years Female Patients who have impaired blood pressure regulation and are taking nitrate-based medications. Patients with diabetes mellitus Patients are taking potassium-sparing drugs. Patients are taking drugs that affect sexual dysfunction and improvement. Patients who have recently had a heart attack. Diagnosis of other psychological disorders along with the diagnosis of major depressive disorder or depression with anxiety in the patient. Consumption of alcohol or drugs or stimulants. Women who are in a menopausal state when starting the study. Lack of access or possibility of sexual intercourse with the husband during the study period. R68.82 F32 Decreased libido Major depressive disorder, single episode Treatment - Drugs Treatment - Drugs Intervention group: receiving L-arginine tablets (produced by Jalinous Pharmaceutical Company) 2 grams per day for 8 weeks. Placebo group: receiving placebo tablets (produced by Jalinous Pharmaceutical Company) for 8 weeks. Sexual function of women. Timepoint: Four weeks before the intervention; Zero, four, and eight weeks after receiving L-arginine. Method of measurement: Rosen et al. questionnaire was used to assess sexual satisfaction for women. Side effects caused by using L-arginine. Timepoint: In two time periods of four and eight weeks after receiving L-arginine. Method of measurement: The patient complaint, clinical evidence, and symptoms. Depression. Timepoint: In three time periods of zero, four and eight weeks after receiving L-arginine. Method of measurement: Hamilton questionnaire. Shahid Beheshti University of Medical Sciences Approved 2022-08-09 Ethics Committee of Faculty of Pharmacy - Shahid Beheshti University of Medical Sciences Faculty of Pharmacy, Shahid Beheshti University of Medical Science, Valiasr St, Hashemi Rafsanjani Highway intersection, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)