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IRCT20230531058351N1 IRCT 2023-06-21 Educational and Research Vice-Chancellor of Abadan University of Medical Sciences Investigating the effect of Date Palm Pollen on women with polycystic ovary syndrome The effect of Date Palm Pollen on follicogenesis and liver enzymes in women with polycystic ovary syndrome: a double-blind randomized clinical trial 2023-09-22 anticipated 40 Complete https://irct.ir/trial/70517 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Randomization tool: table of random numbers In this study, 80 envelopes will be designed, in which there is code A or code B inside each envelope. These codes will indicate the allocation or non-allocation of the intervention. In advance, the necessary coordination will be made with the pharmaceutical company to make the drug and placebo, and the drug and placebo will be separated in containers with code A and B. According to the double-blind study, neither the doctor nor the patient will be unaware of these containers. The patient goes to the doctor and the doctor will place the person in one of these two groups with the help of a table of random numbers. This will continue until 80 people are placed in two groups, Blinding description: In this study, people will be divided into two control and intervention groups using a random number table. . Date palm pollen and dry bread powder will be packaged and coded in exactly the same packages, and the researcher and the subject are not aware of the type of supplement consumed in the packages. 3 polycystic ovary syndrome. Intervention 1: Intervention group: participants in the intervention group received 400 mg Date Palm Pollen once a day after lunch for 12 weeks. After characterizing Date Palm Pollen native to Abadan city, Karen Pharmaceutical Company prepares the product in the form of capsules, Pearl 400 mg. The subjects and the researcher do not know about the allocation of groups. In order to hide the assignment of people to groups, sealed envelopes are used (containing the identification group code of each person along with inserting the person's number on the envelope). A time table is designed to take the medicine. Drug intake was assessed by counting the remaining pearls and by excluding participants who did not consume more than 30% of the drug. Intervention 2: Control group: Participants in the control group received placebo Pearl (dry bread) 400 mg once a day after lunch for 12 weeks. In terms of appearance, placebos are completely similar to date palm pollen herbal medicine, both of which are produced by Karen Pharmaceuticals and Vital Food Supplements Company (Yazd-Tehran). The investigated people and the researcher do not know about the allocation of groups. Placebo and date palm pollen herbal medicine are coded by the manufacturing company. In order to hide the assignment of people to groups, sealed envelopes are used (containing the assigned group code of each person along with the individual's number on the envelope). A schedule is designed to remind you to take the medicine. The evaluation of drug consumption is done by counting the remaining pearls and by removing the participants who have not consumed more than 30% of the drug. Yes - There is a plan to make this available What will be shared: Published as an article When: After publication as an article To whom: After publication as an article Conditions: Published as an article Where to obtain: Author How to obtain: Published as an article Comments:
public Samaneh Karimi
Zulfiqari St, Abadan University of Medical Sciences
Abadan Iran (Islamic Republic of) 6319811154 +98 61 5326 7800 samaneh_k_500@yahoo.com Abadan University of Medical Sciences scientific Samaneh Karimi
Zulfiqari St, Abadan University of Medical Sciences
Abadan Iran (Islamic Republic of) 6319811154 +98 61 5326 7800 samaneh_k_500@yahoo.com Abadan University of Medical Sciences Iran (Islamic Republic of) To diagnose polycystic ovary syndrome according to the Rotterdam criteria, two of the following must be present: 1- Amenorrhea or reduced ovulation frequency Presence of hyperandrogenism based on clinical symptoms (hirsutism and male pattern hair loss) or laboratory (androgen increase) free or increased free androgen index) the presence of evidence of polycystic ovary in ultrasound. 18 years 40 years Female People who use tobacco and alcohol. People suffering from chronic kidney, liver, lung diseases and chronic or acute inflammatory diseases (especially acute inflammation of the pancreas), thyroid dysfunction, heart valve disease, short bowel syndrome. Also, people with low ability of immune system (autoimmunity) are removed from the list of eligible people. These conditions are approved by the clinical consultant in the case of the studied subjects. Also, people who are allergic to medicine or placebo during the study. or taking chemotherapy drugs (tamoxifen) and corticosteroids, or drugs affecting blood sugar and lipids (insulin injections, statins, diuretics), antibiotics and vitamin supplements and omega 3, or suffering from one of the above-mentioned diseases Either they were admitted to the hospital or they had to change the dosage of the drugs they were taking, they were excluded from the study. To overcome the confounding factors, we use the general information questionnaire and the three-day record of people's food intake. E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: participants in the intervention group received 400 mg Date Palm Pollen once a day after lunch for 12 weeks. After characterizing Date Palm Pollen native to Abadan city, Karen Pharmaceutical Company prepares the product in the form of capsules, Pearl 400 mg. The subjects and the researcher do not know about the allocation of groups. In order to hide the assignment of people to groups, sealed envelopes are used (containing the identification group code of each person along with inserting the person's number on the envelope). A time table is designed to take the medicine. Drug intake was assessed by counting the remaining pearls and by excluding participants who did not consume more than 30% of the drug. Control group: Participants in the control group received placebo Pearl (dry bread) 400 mg once a day after lunch for 12 weeks. In terms of appearance, placebos are completely similar to date palm pollen herbal medicine, both of which are produced by Karen Pharmaceuticals and Vital Food Supplements Company (Yazd-Tehran). The investigated people and the researcher do not know about the allocation of groups. Placebo and date palm pollen herbal medicine are coded by the manufacturing company. In order to hide the assignment of people to groups, sealed envelopes are used (containing the assigned group code of each person along with the individual's number on the envelope). A schedule is designed to remind you to take the medicine. The evaluation of drug consumption is done by counting the remaining pearls and by removing the participants who have not consumed more than 30% of the drug. Alanine Aminotransferase(ALT). Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: VT3000 device will be used to measure liver enzymes. Aspartate Aminotransferase(AST). Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: VT3000 device will be used to measure liver enzymes. Alkaline Phosphatase(ALK-P). Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: VT3000 device will be used to measure liver enzymes. 17α hydroxy-progesterone. Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: LC/MS/MS device is used to measure steroid hormones. Progesterone. Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: LC/MS/MS device is used to measure steroid hormones. Androstenedione. Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: LC/MS/MS device is used to measure steroid hormones. Estrogen. Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: LC/MS/MS device is used to measure steroid hormones. LH. Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: LC/MS/MS device is used to measure steroid hormones. CBC. Timepoint: Measurement of biomarkers at the beginning of the study and after the twelfth week. Method of measurement: Blood tests are performed by means of TB counter machines. Educational and Research Vice-Chancellor of Abadan University of Medical Sciences Approved 2022-09-13 Research Ethic Committees of Abadan School of Medical Sciences Zulfiqari St, Abadan University of Medical Sciences Abadan Khouzestan Iran (Islamic Republic of)