]>
IRCT20191106045356N13 IRCT 2022-10-31 Yazd University of Medical Sciences Evaluation of the effects of Gabapentin vaginal gel on Dyspareunia Evaluation of the effectiveness of Gabapentin vaginal gel on pain control in patients with Dyspareunia; A double-blind randomized clinical trial 2022-10-23 anticipated 60 Complete https://irct.ir/trial/66198 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Randomization will be done based on the (RAND) function of Excel and based on this, a table of random numbers is prepared, and the patients are placed in groups A or B according to the rows of this table, and receive the product related to their group, Blinding description: The study will be done in a double-blind manner. Patients and doctors (therapist and evaluator) will not know about the intervention. Worms are numbered by one of the researchers who does not intervene in the study process (treatment, evaluation and data analysis) with labels one and two, and only the same researcher knows about the numbering of worms. Then the numbered creams are delivered to the patients by the doctor. 3 Dyspareunia. Intervention 1: Intervention group: 30 patients with dyspareunia who were treated with 5% gabapentin vaginal gel (gabapentin, hydroxypropyl methylcellulose and carbomer), topical use (vaginal), daily for one to one month. Intervention 2: Control group: 30 patients with dyspareunia who were treated with placebo vaginal gel (hydroxypropyl methyl cellulose and carbomer) used topically (vaginally), once a day for a month. Yes - There is a plan to make this available What will be shared: There is no further information When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: There is no further information Where to obtain: Mohsen Zabihi Professor of Pharmacology, Yazd University of Medical Sciences +98 913 153 6813 mzabihi100@gmail.com How to obtain: No specific details are considered Comments:
public Mohsen Zabihi
Alem sq.
Yazd Iran (Islamic Republic of) 8916774520 +98 35 3820 3865 mzabihi100@gmail.com Yazd University of Medical Sciences scientific Mohsen Zabihi
Alem sq.
Yazd Iran (Islamic Republic of) 8916774520 +98 35 3820 3865 mzabihi100@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) married Suffering from Dyspareunia Insensitivity to gabapentin and vaginal gel base ingredients Not taking vaginal painkillers or systemic gabapentin one week before the start of the study Consent to participate in the study and complete the informed consent form 18 years 50 years Female History of psychiatric diseases Acute and chronic vaginal infection cancer of the female genital tract Pregnancy and breastfeeding N94.1 Dyspareunia Treatment - Drugs Placebo Intervention group: 30 patients with dyspareunia who were treated with 5% gabapentin vaginal gel (gabapentin, hydroxypropyl methylcellulose and carbomer), topical use (vaginal), daily for one to one month. Control group: 30 patients with dyspareunia who were treated with placebo vaginal gel (hydroxypropyl methyl cellulose and carbomer) used topically (vaginally), once a day for a month. NSR Pain Scale. Timepoint: Measurement of NRS scale at the beginning of the study and on days 7, 14, 21 and 28 days after the start of gabapentin gel consumption. Method of measurement: NRS Scale. Yazd University of Medical Sciences Approved 2022-06-26 thics committee of ُ Shahid Sadoughi University of Medical Sciences Alem sq. Yazd Yazd Iran (Islamic Republic of)