The effectiveness of oral tablet based on the Cuscuta epithymum on the pelvic pain, the quality of life and the size of the ovarian cyst of patients with endometrioma

Investigation of the effect of oral tablets based on effetimon on the amount of pelvic pain, quality of life, and ovarian cyst size of patients with endometrioma

A controlled, parallel-group, triple-blind, randomized, blocked, phase 2 clinical trial on 68 patients.

This study is a triple blind clinical trial, which in the first stage of identification of endometrioma patients will be done by examining and performing two-dimensional transvaginal or abdominal ultrasound in a gynecologist's visit. Patients with endometrioma referred who have pelvic pain and endometrioma cysts larger than 2 cm after ultrasound are divided into two experimental and control groups based on a randomized block method, and each will receive medicine for one month. The drug and placebo, which have the same size, color, taste, and smell, are provided to both groups in completely similar containers by the project partner. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed. ​Look up details

Inclusion criteria: 1. Women with endometrioma with pelvic pain and ovarian cysts over 2 cm between the ages of 20 and 45. 2. Absence of Müllerian anomaly, fibrosis, adenomyosis, and myoma. 3. Not taking any medicine except painkillers for endometrioma within 6 months before the visit. Exclusion criteria: 1. Absence of pregnancy or breastfeeding, 2. Severe pain is resistant to treatment that makes the patient a candidate for surgery. 3. Not suffering from acute and serious liver or kidney disease.

The intervention group includes patients with endometriosis who receive the intervention of Ophtimone tablets. The comparison group includes patients with endometriosis who receive placebo pills.

The effect of drugs on patients' pain

Random method: random block We consider two intervention and control groups as A and B. If we consider blocks of 4 or 4 people (to reduce the possibility of error), we will have 6 situations as follows: 1.AABB, 2.ABAB, 3.ABBA, 4.BBAA, 5.BABA, 6.BAAB In any case, we assign a number from 1 to 6. Then, by throwing the dice, one state will be determined each time, and based on the order of that state, we will determine the drug or placebo.for example, if the number two comes in the first throw, that means ABAB mode. So first we put medicine number 1 on a can. Then a can containing placebo number 2, drug number 3 and placebo number 4. In the same way, we throw the dice 17 times (for a sample size of 68 people) and number the cans containing medicine and placebo. be unaware

The drug and placebo, which have the same size, color, taste, and smell, are provided to both groups in completely identical containers based on random allocation by the design partner, so none of the patients are aware of the assigned treatment and will not be informed until the end of the study. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed. In order to analyze the data, a statistician who is separate from the study process and is unaware of all the processes will be used.