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IRCT20220814055687N1 IRCT 2022-09-04 Ardabil University of Medical Sciences Evaluation effect of Viola odorata vaginal suppository on the treatment of vaginal atrophy in post menopausal women Evaluation effect of Viola odorata vaginal suppository on the treatment of vaginal atrophy in post menopausal women 2022-08-24 anticipated 60 Complete https://irct.ir/trial/65265 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a three-blind controlled randomized clinical trial on 60 postmenopausal women. Free Random Number Generator computer software is used for randomization. In this way, a table of random numbers is obtained. Two groups are defined in this software. Group A is the intervention group and Group B is the control group. Then the numbers obtained from this software are recorded by the pharmacist of the group on the medicine box, and the eligible women are assigned to one of the two treatment groups, 30 people on the fragrant violet shelf and 30 people on the placebo suppository based on these numbers, Blinding description: This study is triple-blind type.It means that the researchers, patients and information evaluators are completely unaware of whether the vaginal suppositories are medicines or placebos. The medicines are produced by the pharmacist and the codes are generated by the software, are written on the packets by the pharmacist.packets and suppositories of Viola odorata and placebo are completely similar to each other in shape, size, color and smell. In this study, the evaluators including: the doctor as the first evaluator of the patients' atrophy, the pathologist as the second evaluator of the cytological information and the evaluator of the statistical information as the third person are kept blind. 3 Vaginal Atrophy. Intervention 1: Intervention group: Viola odorata vaginal suppository ,one suppository every night for 8 weeks.This suppository contains flavonoids, mucilage, saponin and a protein called cyclotide. The drug is standardized according to the amount of total flavonoid. 12.9% of total flavonoid in terms of catechin per milliliter.Tabsem Knowledge and Treatment Company. Intervention 2: Control group: Glycerin suppository, one supp every night for 8 weeks.Each suppository contains 2 grams of glycerin, Abu Rihan Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: 0 When: 0oooooo To whom: 000000 Conditions: 000000 Where to obtain: 0 How to obtain: 000000 Comments:
public Fataneh Amindehghan
No 3,Okhovat Ave, Parvin Blv,Tehranpars
Tehran Iran (Islamic Republic of) 1654798844 +98 21 7729 2107 f.amindehghan@arums.ac.ir Ardabil University of Medical Sciences scientific Fataneh Amindehghan
No3,Okhovat Ave,Parvin Blv,Tehranpars
Tehran Iran (Islamic Republic of) 1654798844 +98 21 7729 2107 f.amindehghan@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Women who had natural menopause confirmed by amenorrhea for one year or increased follicle stimulation hormone FSH>40 IU/I Having at least two symptoms from the descriptive evaluation table of the vaginal mucosa Women who are sexually active being married Women who are literate Phone number for follow up no limit no limit Female N95.2 Postmenopausal atrophic vaginitis Treatment - Drugs Placebo Intervention group: Viola odorata vaginal suppository ,one suppository every night for 8 weeks.This suppository contains flavonoids, mucilage, saponin and a protein called cyclotide. The drug is standardized according to the amount of total flavonoid. 12.9% of total flavonoid in terms of catechin per milliliter.Tabsem Knowledge and Treatment Company Control group: Glycerin suppository, one supp every night for 8 weeks.Each suppository contains 2 grams of glycerin, Abu Rihan Pharmaceutical Company Subjective symptoms of vaginal atrophy. Timepoint: Before intervention. 4 and 8 weeks after the treatment. Method of measurement: Likert self-assessment scale. Vaginal Maturation Value. Timepoint: Before intervention and 8 weeks after treatment. Method of measurement: Vaginal smear. Vaginal PH. Timepoint: Before intervention, 8 weeks after treatment. Method of measurement: Litmus paper. Ardabil University of Medical Sciences Approved 2022-08-14 Research Ethics Committee of Ardabil University of Medical Sciences Daneshgah Ave, The northern side of the administrative complex of Ardabil University of Medical Sciences Ardabil Ardabil Iran (Islamic Republic of)