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IRCT20191013045086N1 IRCT 2019-12-22 The University of Trabiat Modares Effects of oral ginger capsules on sexual function women Effects of oral ginger capsules on sexual function and sexual quality of life of married women in the reproductive age 2019-07-21 anticipated 190 Complete https://irct.ir/trial/43490 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be use for randomizing participants within blocks such that an equal number will assigned to treatment. we will give a block size of 4, which there are 6 possible ways to equally assign participants to a block. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specified sequence, Blinding description: In this study, the researcher and the study participants will not aware of the drug or placebo. 3 Sexual dysfunction. Intervention 1: Intervention group: 95 women who were included in the study according to inclusion criteria. They will consume 4 tablets of 250 mg oral ginger daily prepared by Isfahan Flower Drug Company for 4 weeks. Following the intervention, the researcher will contact the research units in the intervention group each week to ensure proper use of the ginger capsule. Evaluation of the research units will be done one month after the intervention using the questionnaires completed by the research units in person. Intervention 2: Control group: 95 women who were included in the study according to inclusion criteria. Placebo capsule containing 250 mg of chickpea powder prepared by Isfahan Flower Drug Company will consume 4 tablets per day orally for 4 weeks. Weekly contact the research units in the intervention group to ensure proper placebo capsule use. Evaluation of the research units will be done one month after the intervention using the questionnaires completed by the research units in person. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Shadab Shahali
Faculty of Medical Sciences, Tarbiat Modares University, Jalal al Ahmad St.
Tehran Iran (Islamic Republic of) 14115-111 +98 21 8288 3811 shadab.shahali@modares.ac.ir Tarbiat Modares University scientific Shadab Shahali
Faculty of Medical Sciences, Tarbiat Modares University, Jalal al Ahmad St.
Tehran Iran (Islamic Republic of) 14115-111 +98 21 8288 3811 shadab.shahali@modares.ac.ir Tarbiat modares university Iran (Islamic Republic of) Reproductive aged women (age: 18-49 years old) Having sex at least twice a month Lack of known underlying disease Lack of mental illness Being a single spouse and living with the spouse now and during the study Can read and write the Persian language Being Iranian Couples not being addicted to drugs or alcohol No-use of drugs that affect the function of the genus No stressful accident during the past month No urinary tract infection Absence of active or lesion in genital area that interferes with sexual intercourse No history of infertility No record of pelvic surgeries No allergy to ginger Absence of pregnancy or lactation 18 years 49 years Female Unwilling to stay in study Not taking ginger capsules Ginger allergy or complications during the intervention Creating active or lesion in the genital area that interferes with intercourse during intercourse Use of drugs that affect sexual function during the intervention Experiencing a stressful accident during the intervention Urinary tract Infection during Intervention F52 Sexual dysfunction not due to a substance or known physiological condition Treatment - Drugs Treatment - Drugs Intervention group: 95 women who were included in the study according to inclusion criteria. They will consume 4 tablets of 250 mg oral ginger daily prepared by Isfahan Flower Drug Company for 4 weeks. Following the intervention, the researcher will contact the research units in the intervention group each week to ensure proper use of the ginger capsule. Evaluation of the research units will be done one month after the intervention using the questionnaires completed by the research units in person. Control group: 95 women who were included in the study according to inclusion criteria. Placebo capsule containing 250 mg of chickpea powder prepared by Isfahan Flower Drug Company will consume 4 tablets per day orally for 4 weeks. Weekly contact the research units in the intervention group to ensure proper placebo capsule use. Evaluation of the research units will be done one month after the intervention using the questionnaires completed by the research units in person. Scores obtained from the Female Sexual Function scale. Timepoint: Assessment of sexual function before and 4 weeks after intervention. Method of measurement: Female sexual function scale. Scores obtained from the Sexual Quality of Life-Female (SQOL-F) questionnaire. Timepoint: Assessment of sexual quality of life before and 4 weeks after intervention. Method of measurement: Sexual Quality of Life-Female (SQOL-F) questionnaire. The University of Trabiat Modares Approved 2019-10-25 Ethics committee of Tarbiat Modares University Faculty of Medicine, Tarbiat Modares University, Jalal al Ahmad high way Tehran Tehran Iran (Islamic Republic of)