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IRCT20131009014957N14 IRCT 2023-06-03 Tabriz University of Medical Sciences Comparing the Effect of Clove Oil and Oral Contraceptive LD on Improvement of Clinical and Paraclinical Parameters of Polycystic Ovarian Syndrome Comparing the Effect of Clove Oil (Syzygium aromaticum) and Oral Contraceptive LD on Improvement of Clinical and Paraclinical Parameters of Polycystic Ovarian Syndrome (PCOS): A Triple Blind Randomized Controlled Trial 2023-12-01 anticipated 64 Complete https://irct.ir/trial/70449 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible people will be allocated into two intervention groups (receiving clove oil) and control (receiving COCs) using the random block method with the size of blocks of four and six with an allocation ratio of 1:1. The allocation sequence will be generated by the assistant of the researcher using RAS (Random Allocation Software). Medicines will be placed inside opaque packs numbered sequentially from 1 to 64 containing three pairs of packets. The intervention will consist of three cycles of 4 weeks. Each person will be given two packets in each cycle, one containing 28 soft capsules of clove oil or its placebo and the other containing 21 LD tablets or its placebo. They will be prepared according to the allocation sequence by a person not involved in the research, Blinding description: The first group every 28 days will receive one daily soft capsule of clove oil and one placebo tablet of COCs for 21 days and 7 days without using it for three cycles and the second group will receive every 28 days, one daily soft placebo capsule of clove oil and one tablet of COCs for 21 days and 7 days without taking it for three cycles. Original drugs will be identical in shape, color, and weight to their placebo counterparts. Participants, the principal investigator, health care personnel, those assessing the outcome and the safety and data monitoring committee, and those preparing the draft of the article will be blinded. 3 Polycystic Ovarian Syndrome. Intervention 1: Intervention group: Receiving 28 soft capsules of clove oil (containing Eugenol) one daily after lunch, along with 21 placebo LD tablets containing an ineffective substance (exactly the same as LD tablets) one daily after dinner and the following seven days without medication for 3 cycles which will be prepared and packaged by the pharmaceutical company. Intervention 2: Control group: Participants in the control group will receive 21 tablets of LD (containing 30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel) once daily after dinner and for the next seven days without medication, along with 28 placebo soft capsules containing an inactive substance (precisely the same as clove oil capsules) one daily after lunch for use in a 28-day cycle, which is packaged and numbered and will be prepared by the pharmaceutical company. Yes - There is a plan to make this available What will be shared: Data on the main outcome will be published When: Six months after printing the results To whom: Researchers at institutions have access to data Conditions: In order to help scientific progress in the field of research Where to obtain: farshbafa@tbzmed.ac.ir How to obtain: Scientific approval of the applicant by Tabriz University of Medical Sciences Comments:
public Azizeh Farshbaf-Khalili
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2295 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Azizeh Farshbaf-Khalili
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2295 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) The diagnosis of PCOS according to the Rotterdam criteria Age 18 to 45 years Being literate BMI between 18.5 and 30 Not using hormonal contraceptives or any other type of hormonal medication currently and during the last three months 18 years 45 years Female Relative and absolute contraindications of LD pills (having blood pressure above 140/90, smoking and alcohol consumption, pregnancy or breastfeeding, alcohol consumption, smoking, suspicion of breast cancer, coronary heart disease, endometrial carcinoma, etc.) Women suffering from amenorrhea Women undergoing infertility treatment at the time of study Previous surgery on one or both ovaries Allergy to clove oil Disorders that cause hyperandrogenism (having Cushing's syndrome, adrenal hyperplasia, androgen-producing tumors, etc.) Thyroid disorders E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: Receiving 28 soft capsules of clove oil (containing Eugenol) one daily after lunch, along with 21 placebo LD tablets containing an ineffective substance (exactly the same as LD tablets) one daily after dinner and the following seven days without medication for 3 cycles which will be prepared and packaged by the pharmaceutical company. Control group: Participants in the control group will receive 21 tablets of LD (containing 30 micrograms of ethinyl estradiol and 150 micrograms of levonorgestrel) once daily after dinner and for the next seven days without medication, along with 28 placebo soft capsules containing an inactive substance (precisely the same as clove oil capsules) one daily after lunch for use in a 28-day cycle, which is packaged and numbered and will be prepared by the pharmaceutical company. The serum levels of dehidroepyandrosteron(DHEA) and total testosterone. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: By the ELISA method using the relevant kits. Hirsutism score. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Using the Ferriman–Gallwey scoring system. The normalization of menstrual cycles. Timepoint: At the beginning of the study and in each 28-day cycle for 3 cycles during the intervention. Method of measurement: Using the menstrual disorders questionnaire. The serum levels of fasting Blood glucose and insulin. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: By spectrophotometry and ELISA method. The serum levels of gonadotropins (FSH and LH). Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: By ELISA method using the relevant kits. Anthropometric indices (waist circumference, hip circumference, body bass index). Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Using anthropometric tools. Quality of life score. Timepoint: Baseline and 12 weeks after the intervention. Method of measurement: Using the health-related quality of life questionnaire of women with polycystic syndrome made by Cronin et al. Tabriz University of Medical Sciences Approved 2023-05-08 Ethics committee of Tabriz University of Medical Sciences Vice Chancellor for Research and Technology, Third floor, No 2-central building, Tabriz University of Medical Sciences, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)