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IRCT20210223050471N1 IRCT 2021-02-28 Mashhad University of Medical Sciences The effectiveness of Artemisia absinthium on sexual performance and satisfaction of women The effectiveness of Artemisia absinthium on sexual performance and satisfaction of women of reproductive age. 2021-04-21 anticipated 76 Complete https://irct.ir/trial/54518 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random sequence of samples is done using random allocation software in two groups A and B Which are intervention and control groups. For Allocation concealment will be using sealed envelopes. A number of envelopes are prepared and each of the random sequences is written on a card and the cards inside the envelope are placed in order and the outer surface of the envelopes is numbered in the same order. Then envelope lids are then glued and placed in the box, respectively. At the beginning of the registration of participants, After giving the necessary explanations to each of the participants and obtaining informed consent, one of the envelopes will be opened in order for the eligible participants to arrive, and the assigned group of the participant will be determined, Blinding description: The drug is placed in two identical boxes and none of the study subjects will be aware of the contents of the boxes except the pharmacist consultant. Depending on the group of participants, gel A or B, previously named by the pharmacist consultant, is given to participants. 3 Condition 1: Sexual function. Condition 2: Sexual satisfaction. Intervention 1: Intervention group: Wormwood with the scientific name (Artemisia absinthium) belongs to the Asteraceae family and is one of the warm native plants, especially in the eastern and northern regions of Iran, and is known as Kharagoush, Gondvash, Marwa and Wormwood. Phytochemical studies of wormwood include a variety of chemical compounds including carbohydrates, alkaloids, saponins, phytosterols, proteins, amino acids, tannins, phenolic compounds, flavonoids. In this study, a vaginal gel tube of 100 g of 5% wormwood (equivalent to 250 mg of available extract) is used. Wormwood is purchased from the approved centers of the university and under the supervision of the esteemed pharmacist of the project, after grinding it, it is soaked in 70% hydroalcoholic solution for 3 days. After this, the desired hydroalcoholic extract is filtered and after removing the solvent, the final extract is obtained. Then the vaginal gel of this extract is prepared based on carbapol with a concentration of 5%. For standardization, the product in terms of total phenol will be standardized by spectrophotometric method. Then it is coded and given to women blindly and they are asked to use this gel vaginally for 4 weeks and 3 times a week (before going to bed) and in case of intercourse, 30 minutes before intercourse. Intervention 2: Control group: In the present study, placebo means a base gel (carbapol) without wormwood extract, which is prepared under the supervision of a pharmacist. The appearance of this gel is similar to the worm wood gel. The method of using this gel is similar to the main drug (wormwood gel), 4 weeks and 3 times a week (before going to bed) and in case of intercourse, 30 minutes before sexual intercourse vaginally. Yes - There is a plan to make this available What will be shared: The data will be shared after it becomes unrecognizable When: 6 months after recording the results To whom: All researchers Conditions: All women with dysfunction and sexual satisfaction Where to obtain: Email niloofarhajatpoor@gmail.com Library of Mashhad School of Nursing to Mashhad, ِDaneshgah Street. How to obtain: First, send a requested email and if you do not respond within a week, you can refer to the library of Mashhad School of Nursing. Comments:
public Dr. Raheleh Babazadeh
School of Nursing and Midwifery, Daneshgah Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Babazadehr@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Raheleh Babazadeh
School of Nursing and Midwifery, Daneshgah Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Babazadehr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Married women 18-45 years old Minimum literacy Having conscious satisfaction Iranian nationality Resident of Mashhad Married and only husband's wife No history of pelvic surgery Absence of infertility Do not use drugs and alcohol in a wife or spouse Absence of any sexual dysfunction in the spouse Absence of pregnancy and lactation Do not take drugs that affect sexual function by the wife or spouse No recent use of hormonal drugs Having at least once a week of normal vaginal sex Absence of abnormal vaginal bleeding Having a regular menstrual cycle with normal bleeding No history of chemotherapy and radiotherapy to the pelvis or the whole body Lack of known medical and psychological illnesses affecting the sexual function of oneself or one's spouse No depression, anxiety, severe stress Sexual function score less than 28 and sexual satisfaction score less than 50 18 years 45 years Female Drug allergy Treatment - Drugs Treatment - Drugs Intervention group: Wormwood with the scientific name (Artemisia absinthium) belongs to the Asteraceae family and is one of the warm native plants, especially in the eastern and northern regions of Iran, and is known as Kharagoush, Gondvash, Marwa and Wormwood. Phytochemical studies of wormwood include a variety of chemical compounds including carbohydrates, alkaloids, saponins, phytosterols, proteins, amino acids, tannins, phenolic compounds, flavonoids. In this study, a vaginal gel tube of 100 g of 5% wormwood (equivalent to 250 mg of available extract) is used. Wormwood is purchased from the approved centers of the university and under the supervision of the esteemed pharmacist of the project, after grinding it, it is soaked in 70% hydroalcoholic solution for 3 days. After this, the desired hydroalcoholic extract is filtered and after removing the solvent, the final extract is obtained. Then the vaginal gel of this extract is prepared based on carbapol with a concentration of 5%. For standardization, the product in terms of total phenol will be standardized by spectrophotometric method. Then it is coded and given to women blindly and they are asked to use this gel vaginally for 4 weeks and 3 times a week (before going to bed) and in case of intercourse, 30 minutes before intercourse. Control group: In the present study, placebo means a base gel (carbapol) without wormwood extract, which is prepared under the supervision of a pharmacist. The appearance of this gel is similar to the worm wood gel. The method of using this gel is similar to the main drug (wormwood gel), 4 weeks and 3 times a week (before going to bed) and in case of intercourse, 30 minutes before sexual intercourse vaginally. Sexual function score. Timepoint: At the beginning of the study and 4 weeks after using the gel. Method of measurement: The Female Sexual Function Index Questionnaire. Sexual satisfaction score. Timepoint: At the beginning of the study and 4 weeks after using the gel. Method of measurement: Larson Sexual Satisfaction Questionnaire. Mashhad University of Medical Sciences Approved 2021-01-26 Ethics Committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Vice Chancellor for Research, Qureshi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)