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IRCT20120718010324N73 IRCT 2022-11-08 Tabriz University of Medical Sciences The Effect of Evening Primrose Oil on Clinical Symptoms in Women with Polycystic Ovary Syndrome The Effect of Evening Primrose Oil on Clinical Symptoms in Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial 2022-10-21 anticipated 62 Complete https://irct.ir/trial/64287 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study will be assigned to two groups (one group receiving evening primrose capsules and one group receiving placebo capsules with the same protocol) by block randomization method with block sizes of 4 and 6 and a allocation ratio of 1: 1. To hide the Allocation (Allocation Concealment), the allocation sequence will be identified by a person not involved in the study using a randomizer software, and the evening primrose oil or placebo capsules will be placed in the same packages numbered sequentially, Blinding description: The participants, researcher and data analyst will be blinded in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research. 3 Polycystic Ovary Syndrome (PCOS). Intervention 1: Intervention group: For each person three matte container including 30 1000 mg evening primrose oil capsules will be prepared with a certain number. At the beginning of the study, a container including evening primrose oil will be given to the patients, and after the end of the first month, the second container will be given to the participants for consumption in the second month and the third c for container consumption in the third month will be given at the end of the second month. The treatment period will continue for three months. The intake method of evening primrose oil capsules is taking of one capsule a day with a glass of water. Intervention 2: Control group: For each person three matte container including 30 1000 mg placebo capsules will be prepared with a certain number. At the beginning of the study, a container including placebo will be given to the patients, and after the end of the first month, the second container will be given to the participants for consumption in the second month and the third c for container consumption in the third month will be given at the end of the second month. The treatment period will continue for three months. The intake method of placebo capsules is taking of one capsule a day with a glass of water. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Participant data is confidential.
public Fatemeh Nouranfar
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
Tabriz Iran (Islamic Republic of) 5135963777 +98 41 3523 0741 fateme96nour@gmail.com Tabriz University of Medical Sciences scientific Mojgan Mirghafourvand
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Confirmation of the diagnosis of PCOS according to the criteria of the Androgen Excess/PCOS Society, including anovulation, chronic low ovulation, or polycystic ovaries and clinical or biochemical signs of hyperandrogenism Minimum hirsutism score of 6 with the Freeman Galloway criterion Having literacy to complete the questionnaires BMI between 18.5 and 40 Ages 18-45 years Not taking vitamins, minerals and omega-6 in the three months before the intervention 18 years 45 years Female Having other androgenic disorders such as adrenal hyperplasia or androgen-producing tumor Having Cushing's syndrome Having thyroid gland diseases Pregnancy or breastfeeding Women undergoing infertility treatment at the time of the study Previous surgery on one or both ovaries Consumption of dietary supplements Smoking and alcohol consumption Occurrence of unfortunate events E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group: For each person three matte container including 30 1000 mg evening primrose oil capsules will be prepared with a certain number. At the beginning of the study, a container including evening primrose oil will be given to the patients, and after the end of the first month, the second container will be given to the participants for consumption in the second month and the third c for container consumption in the third month will be given at the end of the second month. The treatment period will continue for three months. The intake method of evening primrose oil capsules is taking of one capsule a day with a glass of water. Control group: For each person three matte container including 30 1000 mg placebo capsules will be prepared with a certain number. At the beginning of the study, a container including placebo will be given to the patients, and after the end of the first month, the second container will be given to the participants for consumption in the second month and the third c for container consumption in the third month will be given at the end of the second month. The treatment period will continue for three months. The intake method of placebo capsules is taking of one capsule a day with a glass of water. Hirsutism score. Timepoint: Before the intervention and after the end of intervention. Method of measurement: Ferriman – Gallwey index. Depression symptoms score. Timepoint: Before the intervention and after the end of intervention. Method of measurement: Beck Depression Inventory. Frequency of adverse events in the study groups. Timepoint: During the intervention. Method of measurement: Researcher-made checklist. Anthropometric indices (waist circumference, hip circumference, BMI). Timepoint: Before and after the intervention. Method of measurement: Checklist of anthropometric indices. Menstrual disorders. Timepoint: Before and after the intervention. Method of measurement: Menstrual characteristics questionnaire. Tabriz University of Medical Sciences Approved 2022-10-07 Ethics committee of Tabriz University of Medical Sciences Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)