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IRCT20101130005280N33 IRCT 2020-06-03 Mashhad University of Medical Sciences The efficacy of the extracts of Tribulus Terrestris and Lepidium Meyeni on improvement of sexual interest in females Evaluation of the efficacy of Tribulus Terrestris and Lepidium Meyeni extracts on improvement of sexual interest in females 2020-05-05 anticipated 60 Complete https://irct.ir/trial/47518 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one patient and places her in one of the three groups, Blinding description: In this study, participants are not aware of the type of treatment and the intervention. Also, outcome assessors are unaware of the the grouping. Patients in the control group receive placebo drug. 2-3 sexual interest. Intervention 1: Intervention group 1: In this group, patients receive one capsule of Tribulus Terrestris extract (produced in the faculty of pharmacy) one hour after one of the meals daily for one month. Intervention 2: Intervention group 2: In this group, patients receive one capsule of Lepidium Meyenii extract (produced in the faculty of pharmacy) one hour one of the meals daily for one month. Intervention 3: Control group: In this group, patients receive one capsule of placebo drug one hour one of the meals daily for one month. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable When: Data can be accessible 6 months after results are published To whom: All academic institutes and non-academic industrial institutes which are related to our studies will have access to our data after going through legal procedures. Conditions: In case those people asking for data have the intention of optimizing the study an data and producing more results, access to data is allowed. Where to obtain: Through sending an email to the corresponding author, data will be obtainable. How to obtain: In case someone asks for data, he must first get in contact with the corresponding author for his identity to be fully verified. Then if university allows propagation of data, it will be accessible in 3 months Comments:
public Ali Manteghi
Ebnesina hospital, Horre Ameli Ave
Mashhad Iran (Islamic Republic of) 919583134 +98 51 3711 2701 manteghia@mums.ac.ir Mashhad University of Medical Sciences scientific Ali Manteghi
Ebnesina hospital, Horre Ameli Ave
Mashhad Iran (Islamic Republic of) 919583134 +98 51 3711 2701 manteghia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Married women between 18 to 50 years old with lack of sexual interest based on DSM5 (who has satisfactory relationship with her husband and live with him at least 15 days in a month and is also sexually active) Normal pelvic examination Normal breast examination in the past 2 month no pregnancy and breastfeeding not having menstruation for more than two months 18 years 50 years Female Hormonal or anatomical diseases which prevent orgasm such as diabetes, cerebrovascular diseases, liver-kidney-heart problems, hypothyroidism History of cancer or psychological disorders which are under treatment such as breast and pelvic cancer or depression, anxiety and psychosis husband's sexual problem no active plan for divorce F52.22 Female sexual arousal disorder Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: In this group, patients receive one capsule of Tribulus Terrestris extract (produced in the faculty of pharmacy) one hour after one of the meals daily for one month. Intervention group 2: In this group, patients receive one capsule of Lepidium Meyenii extract (produced in the faculty of pharmacy) one hour one of the meals daily for one month. Control group: In this group, patients receive one capsule of placebo drug one hour one of the meals daily for one month. Rate of sexual interest. Timepoint: Before and at the end of the one -month treatment. Method of measurement: Administration of Arizona Sexual Experience Scale (ASEX). Mashhad University of Medical Sciences Approved 2018-11-27 Ethics committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)