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IRCT20210915052488N1 IRCT 2021-11-18 Kermanshah University of Medical Sciences Effect of lavender in treatment of polycystic ovary syndrome Comparative study of the effect of lavender versus metformin on polycystic ovary syndrome 2021-11-22 anticipated 68 Complete https://irct.ir/trial/58814 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Fasting glucose and insulin levels, prolactin, serum basal progesterone and TSH and free testosterone are measured. For patients with a radiologist with a vaginal ultrasound, a polycystic ovary view must be confirmed, Randomization description: Randomization will be done in block method with 4 blocks. Random sequencing will be generated by the epidemiology and statistics consultant using the site https://www.sealedenvelope.com. Randomization unit: individual Hide: Only the consultant will be aware of the random sequence. In the mentioned site, it is possible to assign a code to each person. Therefore, the next person will not know what treatment he is going to receive (A or B) and only the person who performed the random sequence And will not be involved in assigning samples to groups and evaluating patients will be aware of the random sequence, Blinding description: In this Clinical trial is double-blind. The participant and the data evaluator will not know the type of treatment assigned. The shape of the drugs and their box are quite similar and Neither the participant nor the evaluator will know about its content. 2-3 Polycystic ovary syndrome. Intervention 1: Intervention group: The drug is in the form of 500 mg capsules(One hundred grams of lavender is boiled in one liter of water to reach 100 milliliter The solution is then passed through a strainer. The filtered solution is poured into a snail to reach a concentration of 100 to 10 gram of dry extract. Capsules are made using 250 mg of starch oxide and 250 milligram of lavender. Product standardization is based on the total phenolic content).It is prescribed twice a day for three months. Made by Engineer Kamalinejad in the laboratory of the Faculty of Pharmacy, hahid Beheshti University of Medical Sciences, Tehran. Intervention 2: Control group: This group is prescribed metformin 500 milligram tablets three times a day for three months.From the pills of Abidi Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: In this study scientific data Except for personal data of individuals will be shared. When: Scientific content will be available six months after the results are published To whom: Scientific data and documentation will be available to researchers Conditions: There are no special conditions. Where to obtain: Saeed Reza Simaei sreza.simaei@kums.ac.ir How to obtain: After confirming the reference, the file will be sent to the applicant no later than one month later Comments:
public Saeed Reza Simaei
No.20, 21, Adalat St., Ahmadabad Blvd.
Mashhad Iran (Islamic Republic of) 9176614849 +98 51 3847 0500 sreza.simaei@kums.ac.ir Kermanshah University of Medical Sciences scientific Saeedreza Simaei
No 20, Adalat 21 Ave., Ahmadabad Blvd
Mashhad Iran (Islamic Republic of) 9176614850 +98 51 3844 2398 sreza.simaei@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Diagnosis of polycystic ovary syndrome by a gynecologist 18 years 45 years Female Do not take drugs that lower blood pressure, blood fats and blood sugar No pregnancy or breastfeeding Do not take insulin sensitizers Do not take aspirin or other anticoagulants Do not take anti-prostaglandin drugs Do not take other herbal medicines at the same time for your disease No history of uncontrolled blood pressure, stroke, heart attack, cancer or heart attack, cardiovascular disease, liver, kidney and thyroid disorders, type 1 or 2 diabetes No smoking Do not take oral contraceptives E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: The drug is in the form of 500 mg capsules(One hundred grams of lavender is boiled in one liter of water to reach 100 milliliter The solution is then passed through a strainer. The filtered solution is poured into a snail to reach a concentration of 100 to 10 gram of dry extract. Capsules are made using 250 mg of starch oxide and 250 milligram of lavender. Product standardization is based on the total phenolic content).It is prescribed twice a day for three months. Made by Engineer Kamalinejad in the laboratory of the Faculty of Pharmacy, hahid Beheshti University of Medical Sciences, Tehran. Control group: This group is prescribed metformin 500 milligram tablets three times a day for three months.From the pills of Abidi Pharmaceutical Company Check menstrual days. Timepoint: After three months of treatment in the luteal phase. Method of measurement: Day. Measurement of serum Progesterone in the luteal phase. Timepoint: After three months of treatment in the luteal phase. Method of measurement: Measurement of serum progesterone in the luteal phase more than 3 Nanogram / milliliter. Kermanshah University of Medical Sciences Approved 2021-08-10 Ethics Committee of Kermanshah University of Medical Sciences No. 2, Central Building., Kermanshah University of Medical Sciences., Shahid Beheshti Street Kermanshah Kermanshah Iran (Islamic Republic of)