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IRCT20210810052135N1 IRCT 2022-05-05 Khoram-Abad University of Medical Sciences Evaluation of the effect of lactic acid in the treatment of dryness, burning and vaginal infections The effect of lactic acid-containing vaginal cream in the treatment of dryness, burning and vaginal infection in women 2022-05-22 anticipated 240 Complete https://irct.ir/trial/58049 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In lactic acid and clindamazole intervention, 120 samples were selected using stratified random block method in two groups (60 people in each group) and in lactic acid and estrogen intervention, 120 people (60 people in each group). Are placed in such a way that the menopausal status (postmenopausal and non-menopausal women) is first considered as a class. Then, in the samples of postmenopausal and non-menopausal women, the samples will be randomly assigned to the two groups using 4 random blocks. This method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization ensures that no significant imbalance is established between groups at any time during randomization, and at certain points the number of participants in each group is equal. For this method, the volume of each block must first be specified (Example of a quadruple block). Then write a list of blocks and assign numbers to them (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then select random numbers from one to 6 (Eg 1 4 5 and ...) and finally specify the treatment allocation list based on random random numbers (… AABB-BBAA-BABA-). Participants are placed in different classes based on pre-selected factors and factors and randomization is done in each category. Randomization in each class can be simple randomization or block randomization. The advantage of this method is the comparability of groups based on specific factors. Random samples are a subset of data selected from a larger data set, our population. Each individual is selected from a random sample completely randomly, and the probability of equal selection in this case is equal, and in principle, to obtain a non-biased representation of the whole population. The letters inside the blocks (A and B) also indicate the patient's type, Blinding description: This clinical trial is three-way blind. 1. Participants in research who are patients, 2. Researchers or implementers of the project 3. People who analyze the obtained data. In this study, blindness is such that there is an external observer in these studies who assigns a common name to drugs (intervention) and placebo (control) such as: A and B. The participant / researcher / statistical consultant knows who is in group A and who is in group B. But neither knows if group A is an intervention or a control. Finally, after studying and interpreting the results by the statistician, the observer reveals what group each name belonged to. 3 Vaginal dryness and burning and infections. Intervention 1: Interference group:1. Estromarin-containing vaginal cream (for patients with irritation and vaginal drynessClindamazole vaginal cream (for patients with vaginal infection)These drugs contain an applicator for intravaginal use, which is provided to patients after two sessions of training on how, when and how much to take. At the end, a contact number will be given to answer patients' questions about any questions. Intervention 2: Intervention group:1. Lactic acid vaginal cream (for patients with irritation and dryness and/or vaginal infections)These drugs contain an applicator for intravaginal use, which is provided to patients after two sessions of training on how, when and how much to take. At the end, a contact number will be given to answer patients' questions about any questions. Yes - There is a plan to make this available What will be shared: Information on the main implications is available through the article. When: The access period starts one year after the results are published. To whom: Only for researchers working in academic and scientific institutions Conditions: Data analysis is allowed but the right to use the documents is not allowed. Where to obtain: Applicants can contact the project manager via email to receive data. How to obtain: The applicant must first submit your application. If the request is approved, he / she will sign an undertaking form not to use it industrially and provide it to others, and then the data will be sent to them. Comments:
public Amin Hasanvand
kamalvand
Khorramabad Iran (Islamic Republic of) 381251698 0986633120172 dr.hasanvand@yahoo.com Khoram-Abad University of Medical Sciences scientific Amin Hasanvand
Kamalvand
Khorramabad Iran (Islamic Republic of) 381251698 +98 66 3312 0172 dr.hasanvand@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Married women aged 18-70 who are not pregnant, breastfeeding or menopausal. The sample population did not have vaginal bleeding and had not used a vaginal cream or suppository in the past 48 hours The sample population has not used antibiotics or antifungals to treat vaginitis in the last 2 weeks. The specimens should not have used corticosteroids in the past 2 weeks 18 years 70 years Female Existence of other infections associated with candidiasis Presence of certain diseases in the samples Treatment - Drugs Treatment - Drugs Interference group:1. Estromarin-containing vaginal cream (for patients with irritation and vaginal drynessClindamazole vaginal cream (for patients with vaginal infection)These drugs contain an applicator for intravaginal use, which is provided to patients after two sessions of training on how, when and how much to take. At the end, a contact number will be given to answer patients' questions about any questions. Intervention group:1. Lactic acid vaginal cream (for patients with irritation and dryness and/or vaginal infections)These drugs contain an applicator for intravaginal use, which is provided to patients after two sessions of training on how, when and how much to take. At the end, a contact number will be given to answer patients' questions about any questions. Vaginal dryness and burning and infections. Timepoint: The first day and the fourteenth day. Method of measurement: questionnaire. Lorestan University of Medical Sciences Approved 2022-04-05 Ethics committee of Lorestan University of Medical Sciences Kamalvand Pardis Khorramabad Lorestan Iran (Islamic Republic of)