Evaluation of the Effects of Traditional Dosage form Called Hamol-e-Aftimone in Improving Pelvic Pain, Quality Of Life And Ovarian Cyst Size in Endometriosis Patients; A Double-Blind, Placebo-Controlled Clinical Trial

Evaluation of the effect of traditional Dosage form of Hamol-Aftimone in improving pelvic pain, quality of life and ovarian cyst size in endometriosis patients.

It is a double-blind clinical trial controlled with placebo and has two groups of 34 people receiving traditional medicine and placebo, which will be randomized using random block allocation.

The patients are selected from those who visit Sari Emam Khomeini Hospital and receive the drug or placebo. The daily pain questionnaire is filled by the patient. At the end of the first and second month, size of ovarian cyst is measured, the amount of NSAIDs and the patient's quality of life are evaluated by the researcher. It should be noted that the patient, physician and researcher are blinded.

1. Women suffering from endometriosis with pelvic pain and ovarian cysts over two cm between 20 and 45. 2. Absence of Müllerian anomaly, fibrosis, adenomyosis and myoma 3. No medication except pain reliever for endometriosis within 6 months before referral 4. The patient's consent to participate in the plan. People who are pregnant or breastfeeding, have severe pain that is resistant to treatment, have acute liver, kidney disease or any malignancy, or have a previous pap smear with intraepithelial pathological changes are not included in the study.

In the intervention group, patients take the prepared traditional medicine in the form of vaginal suppositories once a day for two months. Also, in the control group, placebo is consumed with the same prescription for two months.

Amount of pain, NSAIDs consumption, ovarian cyst size and Quality of life.

Random allocation block method will be used. The number of considered blocks is 4. The list of random allocation of patients will only be at the disposal of the project methodologist. In order to hide the random allocation process, random 10-digit codes are written on the paper labels without a specific order and framework, which is the identification number of the relevant treatment and only the project methodologist will be aware of the relevant code. The labels will be stuck on the drug packages in order of the randomization list. Drug packages will be arranged in the order of the randomization list inside the box. When the doctor declares the eligibility of a patient, the methodologist will provide the patient with the package treatment plan. The person evaluating the intended outcomes is a third person who is unaware of the randomization process and the type of treatment performed.

The drug and placebo, which have the same size, color, and smell, are provided in the same containers based on random allocation by both groups, so none of the patients were 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.

Results from clinical trials

2 Month after publishing

Allowed only with the mention of the source.

For traditional pharmacy researchers

Fateme Alizade 09387845915

Asking from the resercher