The effect of lactic acid-containing vaginal cream in the treatment of dryness, burning and vaginal infection in women

The effect of lactic acid-containing vaginal cream in the treatment of dryness, burning and vaginal infection in women

Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 3 on 240 patients.The random function of Excel software was used for randomization.

Authorized obstetrics and gynecology clinics in Khorramabad

Married women aged 18-70 who are not pregnant, breastfeeding or menopausal. They also do not have vaginal bleeding and have not used a vaginal cream or suppository in the last 48 hours

Placebo group: A group that receives a placebo. Group therapy: A group that receives medication.Participants and obstetricians had no knowledge of placebo or treatment and were randomly given medication or placebo, and at the end it was determined who was in the placebo group and who was in the treatment group.

Vaginal itching, Vaginal burning, Vaginal moisture, The amount of vaginal discharge, Vaginal discharge color, Pain during intercourse, Abnormal vaginal bleeding or spotting

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.

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.

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