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IRCT20190202042596N2 IRCT 2022-11-09 Mashhad University of Medical Sciences Acupuncture for treatment of abnormal uterine bleeding Evaluation of the effect of acupuncture on regulating the menstrual cycle in the patients with abnormal uterine bleeding 2022-10-22 anticipated 76 Complete https://irct.ir/trial/57612 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into intervention and control groups using the random block method using the website sealedenvelop.com. Allocation concealment will be done using opaque, sealed and numbered envelopes. N/A Abnormal uterine bleeding. Intervention 1: Intervention Group: 12 weekly acupuncture treatment sessions besides routine drugs for example progestogenic pills such as tab medroxyprogesterone for 10 days, 10 mg daily from the 14th day of the cycle, cyclic tab combined estrogen-progesterone pills, non-steroidal anti-obesity drugs such as cap mefenamic acid 500 mg q 8 h and cap tranexamic acid 500 mg q 8 h. Intervention 2: Control group: Routine Drugs for example progestogenic pills such as medroxyprogesterone, combined estrogen-progesterone pills, non-steroidal anti-obesity drugs and tranexamic acid. Yes - There is a plan to make this available What will be shared: Information on the main outcomes is shared When: The access period begins three months after the publication of the results To whom: Academic researchers Conditions: Using data to check the quality of analysis Where to obtain: Mahnaz Boroumand Rezazadeh Department of Obstetrics and Gyneccology, Mashhad University of Medical Sciences How to obtain: one month after request Comments:
public Mahnaz Boroumand Rezazadeh
Sanabad
Mashhad Iran (Islamic Republic of) 9138943662 +98 51 3842 1052 boroumandrm@mums.ac.ir Mashhad University of Medical Sciences scientific Mahnaz Boroumand Rezazadeh
Sanabad
Mashhad Iran (Islamic Republic of) 9138943662 +98 51 3842 1052 boroumandrm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Irregular menstrual cycle in the form of: 1-Polymenorrhea (menstrual cycle time less than 21 r) 2-Oligomenorrhea (menstrual cycle duration more than 35 days) 3-Bleeding between cycles 4-Spotting before or after menopause 5-hypermenorrhea (uterine bleeding more than 80 cc In each cycle, blood clot excretion more than 2 hours, the need to replace the night pad, severe uterine bleeding leading to anemia) 6-Absence of structural disorders justifying bleeding such as Fibroids, polyps, hyperplasia, cancer, adenomyosis, etc. 7-Consent to participate in the study and use of acupuncture 9-No Acupuncture Contraindications - Acupuncture Contraindications: Pregnancy, skin problems such as infection or inflammation at the site of acupuncture no limit 50 years Female 1-Trauma 2-Drugs 3-Postpartum 4-Structural disorders such as fibroids, polyps, hyperplasia, cancer, adenomyosis, etc. 5-Failure to follow the course of treatment, 6-Postmenopausal bleeding 7-Vaginal bleeding due to pregnancy complications N93.9 Abnormal uterine and vaginal bleeding, unspecified Treatment - Other Treatment - Drugs Intervention Group: 12 weekly acupuncture treatment sessions besides routine drugs for example progestogenic pills such as tab medroxyprogesterone for 10 days, 10 mg daily from the 14th day of the cycle, cyclic tab combined estrogen-progesterone pills, non-steroidal anti-obesity drugs such as cap mefenamic acid 500 mg q 8 h and cap tranexamic acid 500 mg q 8 h Control group: Routine Drugs for example progestogenic pills such as medroxyprogesterone, combined estrogen-progesterone pills, non-steroidal anti-obesity drugs and tranexamic acid Length of menstrual cycle. Timepoint: The period of six months- The duration of the monthly menstrual cycle is checked before the intervention and immediately after the completion of the three-month course of acupuncture and drug treatment and three months after the end of the intervention. Method of measurement: Reassessment of signs & symptoms. Duration of menstrual bleeding. Timepoint: The period of six months- The duration of the monthly menstrual bleeding is checked before the intervention and immediately after the completion of the three-month course of acupuncture and drug treatment and three months after the end of the intervention. Method of measurement: Reassessment of signs & symptoms. Intensity of monthly bleeding. Timepoint: The period of six months- The intensity of monthly bleeding is checked before the intervention and immediately after the completion of the three-month course of acupuncture and drug treatment and three months after the end of the intervention. Method of measurement: Reassessment of signs & symptoms. Frequency of menstrual habits. Timepoint: The period of six months- The frequency of menstrual habits is checked before the intervention and immediately after the completion of the three-month course of acupuncture and drug treatment and three months after the end of the intervention. Method of measurement: Reassessment of signs & symptoms. Mashhad University of Medical Sciences Approved 2022-09-18 Ethics Committee of Mashhad Medical School Sanabad Mashhad Razavi Khorasan Iran (Islamic Republic of)