Investigation of the effect of Reepaven drug on severity of pain and bleeding during menstruation in women of childbearing age compared with placebo

Determination of the effect of Reepaven drug on the severity of pain and bleeding during menstruation in women compared to placebo

Clinical trial study with control group, with parallel groups, double-blind, randomized by simple randomization method using random numbers table, 80 patients, phase 3

In this study, the samples were selected from women who suffer from painful menstruation or heavy bleeding, using the Convenience Sampling method and individuals were divided into groups by simple randomization. If patients wish to participate in this research, first the goals and method of conducting the study for patients were explained and then, a written consent was obtained from all volunteer patients. In this study, 80 women were randomly assigned to study in two groups of 40 people (the Reepaven group and the placebo group). At the first visit, after recording the severity of pain during menstruation and completing the women's health questionnaire, patients will be asked to take 3 pills (after breakfast, lunch, dinner) during the first two days of menstruation. And in the remaining days, take 2 tablets daily (after lunch and dinner), and at the next visit, the severity of the pain and the women's health questionnaire will be recorded again. In addition, all patients are told that they can use previous drugs and methods that can be used to relieve pain and reduce bleeding if desired, and this combination drug is a complementary treatment.

Inclusion criteria: Painful menstrual bleeding or heavy bleeding; Aged 18-50 years; exclusion Criteria: Pregnancy or lactation; Menopause; Patient's reluctance to cooperate; Not taking the drug during the study

Reepaven drug group, placebo group

Pain intensity; Bleeding intensity; Impact of disease severity on daily activities

In this study, patients were assigned to two groups of Reepaven and placebo based on a Simple randomization method. This means that all participants had an equal chance of being in each group. The first step is to create a random sequence. For this purpose, we used a table of random numbers. From the beginning, it was decided to go down to read the numbers in the table of random numbers, after selecting the starting point. We then determined that even numbers were assigned to the intervention group and individual numbers were assigned to the placebo group. Due to the fact that when using simple randomization methods, especially in low sample size, it is possible that the two groups do not equal at the same time, so if a group reaches its sample size earlier, then we must ignore the relevant figures, and complete the opposite group. One of the project's colleagues put his finger on a point in the table with his eyes closed, and then, as scheduled, moved down and wrote down the numbers until they reached the sample size in both groups. Each number, depending on whether they were even or odd, represented a group to which we assigned code A (intervention) and B (placebo). With this method, we had a specific sequence of 80 codes A and B at the end, indicating that the first to eightieth person to be included in the study should belong to each group. We wrote the code on a piece of paper in order and put it in an envelope, to use it during sampling. Thus, after reviewing the entry criteria and, if the client wishes, we entered each person into the groups according to our pre-determined list.