Investigation the effects of Arctium Lappa root powder on some markers of oxidative stress and inflammation in women with polycystic ovary syndrome: a randomized double blind clinical trial study

Effects of Arctium Lappa root on serum levels of some biochemical variables in women with polycystic ovary syndrome

In this randomized, double-blind, phase 2 study, a total number of 60 people with polycystic ovary syndrome will be selected. They will be divided into two groups of Arctium Lappa root and placebo by block randomization method. They will be matched in age and BMI.

The purpose of the study and how to do it will be explained to patients and written consent will be obtained from them to participate in the study in Taleghani hospital, Arak. Blood samples are taken from patients at the beginning of the study(Sampling is done in the clinic)and factors such as blood fat and etc. are measured in the blood(measurement is done in the Arak university of medical sciences laboratory).Then, the herbal medicine will be used in the participants for 12 weeks, and after this period, blood samples will be taken again and the factors will be measured again in order to evaluate the effect of the medicine. Patients and specialist will not be aware of the type of groups.

women in the age range of 18-45 years;whose PCOS has been confirmed by a specialist based on Rotterdam criteria;Only patients who do not intend to become pregnant are allowed to enter our study because the profile of therapeutic drugs of them is different from those who intend to become pregnant.The exclusion criteria are:consumption anticoagulant drugs and antioxidant and anti-inflammatory supplements 3 months before the study; suffering from diabetes;thyroid disorders;and hyperprolactinemia.

Recipient group of Arctium Lappa root(One 460 mg capsule per day)and recipient group contains starch with the same dose.

Markers of oxidative stress and inflammation

Additional clarification and rectification of these items: Inclusion criteria (adding Rotterdam criteria), blinding method description, timepoint of measurement, and also measurement method of the variable "menstrual frequency".

The random allocation method will be used and the patients are placed in the intervention or control group using the block random allocation method with blocks of four. By assigning the letter A to the intervention group and the letter B to the control group, six states AABB, BBAA, BABA, ABBA, BAAB, and ABAB are written on separate sheets and are thrown into a container, and each time one of the sheets is taken out and it's written composition is noted and the sheet is thrown into the container again. Since the sample size in this study is 60, this procedure is repeated 15 times and each time the combination written on each sheet is noted in the sequence of the previous sheet. Then, a number from one to sixty is assigned to each of the letters in the order of the letters noted one after the other, and each of the letters are placed in an envelope and the specific number of each letter is written on the envelope. Every time which a subject is selected, one of the envelopes is opened. According to the number written on the envelope, the patient is introduced into the intervention or control group.

Participants and healthcare providers are blinded. The drug and placebo are packaged in similar packages. The treatment group and placebo group will not be aware of the type of intervention they receive.

Only results of main outcomes

Six months after publishing of the results

Only for academic staffs and universities researches

Only for international and between universities researches

Ali Khosrowbeygi a.khosrowbeygi@arakmu.ac.ir

1. Requesting a team work clinical trial via email. 2. Approving the proposal. 3. Registration of the trial.

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