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IRCT20210216050382N1 IRCT 2021-02-25 Mashhad University of Medical Sciences The effect of urtica dioica on vaginal atrophy The effect of urtica dioica plant vaginal cream on vaginal atrophy and sexual quality of life in menopausal women 2021-05-22 anticipated 102 Complete https://irct.ir/trial/54393 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The allocation of postmenopausal women to three groups of urtica dioica vaginal cream, conjugated estrogen and placebo will be simple random with random sequence created by www.randomization.com. The random sequence created by the site is provided to the pharmacist consulting professor so that the creams are labeled with one of the codes A, B and C without informing the other members of the research team. After the entry of each person with the conditions of inclusion in the study, according to the above random sequence, one of the creams A, B and C will be delivered to him, Blinding description: Urtica dioica vaginal cream, placebo and conjugated estrogen will be poured into exactly the same tubes. The creams are similar in shape and color and only the pharmacist consulting professor will know the codes assigned to the creams. 3 Vaginal atrophy. Intervention 1: Intervention group: Vaginal cream 5. urtica dioica plant made in the pharmacology department of medicinal plants of Mashhad University of Medical Sciences, for 8 weeks, the first 2 weeks every night and the next 6 weeks twice a week, 1 gram (Equivalent to 50 mg of extract) will be used every night. In clinical trials, a dose of 600 mg has been used for allergic rhinitis, and 600-1200 mg daily for 6-9 weeks for benign prostatic hyperplasia. The average oral lethal dose in rats was estimated to be more than 30 g / kg for aqueous leaf extract and 1.3 g / kg for roots. Intervention 2: Control group: Conjugated estrogen vaginal cream for 8 weeks, the first 2 weeks every night and the next 6 weeks twice a week, 1 gram per night will be used. Intervention 3: Control group: Placebo vaginal cream containing Farabi cream base made in the Department of Medicinal Plants Pharmacology of Mashhad University of Medical Sciences, for 8 weeks, the first 2 weeks every night and the next 6 weeks twice a week, 1 gram per night will be used. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is -
public Nahid Nazari
School of Nursing and Midwifery, Ibn Sina Street, Doctora Crossroads, Daneshgah Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 nazarin982@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Zahra Karimi
School of Nursing and Midwifery, Ibn Sina St., Doctora Crossroads, Daneshgah Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Karimifz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iranian and resident of gorgan Satisfaction to participate in the study Literacy for reading and writing Married and sexually active in the past 6 months Normal menopause Age 45-60 Normal pap smear Diagnosis of vaginal atrophy (score of 4 or more on the vaginal atrophy questionnaire and vaginal PH greater than 5 and VMV equal to or less than 55) 45 years 60 years Female Use of phytoestrogens (soy, flaxseed, red clover, fennel, nettle) one month before the start of the study Hormone therapy for 6 months before the start of the study Abnormal vaginal bleeding (spotting, pink or brown discharge, or obvious bleeding) Specific medical diseases (history of ovarian, breast and endometrial cancer - cardiovascular disease - history of thromboembolism or thrombophlebitis - history of coagulation diseases - history of ischemic stroke - migraine headaches - seizures - uterine leiomyoma - endometriosis - hypertension - diabetes - hyperlipidemia- liver and gallbladder disease - chronic kidney disease - tobacco use history - genitourinary abnormalities (uterine unicorn, bicornuate, double and septate) Use of certain medications (hormonal medications - moisturizers and vaginal gels - antihypertensive drugs - diuretics - antidepressants - antipsychotics - lithium - antihistamines - barbiturates - narcotics - benzodiazepines - hallucinogens - amphetamine – cocaine- digoxin) Vaginal infections (candida-trichomonas-bacterial vaginosis-std-herpes) History of estrogen sensitivity (breast pain, breast tenderness and sensation, spotting, itching, burning, redness) History of nettle sensitivity N95.2 Postmenopausal atrophic vaginitis Treatment - Drugs Treatment - Drugs Placebo Intervention group: Vaginal cream 5. urtica dioica plant made in the pharmacology department of medicinal plants of Mashhad University of Medical Sciences, for 8 weeks, the first 2 weeks every night and the next 6 weeks twice a week, 1 gram (Equivalent to 50 mg of extract) will be used every night. In clinical trials, a dose of 600 mg has been used for allergic rhinitis, and 600-1200 mg daily for 6-9 weeks for benign prostatic hyperplasia. The average oral lethal dose in rats was estimated to be more than 30 g / kg for aqueous leaf extract and 1.3 g / kg for roots. Control group: Conjugated estrogen vaginal cream for 8 weeks, the first 2 weeks every night and the next 6 weeks twice a week, 1 gram per night will be used. Control group: Placebo vaginal cream containing Farabi cream base made in the Department of Medicinal Plants Pharmacology of Mashhad University of Medical Sciences, for 8 weeks, the first 2 weeks every night and the next 6 weeks twice a week, 1 gram per night will be used. Mental symptoms of vaginal atrophy. Timepoint: Before the study, 4 and 8 weeks after the intervention. Method of measurement: Vaginal assessment scale. Vaginal PH. Timepoint: Before the study, 4 and 8 weeks after the intervention. Method of measurement: PH-indicator strips. Vaginal maturation index. Timepoint: Before the study, 4 and 8 weeks after the intervention. Method of measurement: Pathological examination. Vaginal maturation value. Timepoint: Before the study, 4 and 8 weeks after the intervention. Method of measurement: Pathological examination. The sexual quality of life. Timepoint: Before the study, 4 and 8 weeks after the intervention. Method of measurement: The sexual quality of life female questionaire. Mashhad University of Medical Sciences Approved 2021-02-09 Ethics Committee of Mashhad University of Medical Sciences-School of Nursing and Midwifery School of Nursing and Midwifery, Ibn Sina St., Doctora Crossroads, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)