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IRCT201512107265N4 IRCT 2016-06-14 Mashhad University of Medical Sciences Efficacy and safety of cryotherapy in comparison with Chinese herbal medicine in the treatment of chronic cervicitis and cervical erosion Efficacy and safety of cryotherapy in comparison with Chinese herbal medicine in the treatment of chronic cervicitis and cervical erosion 2015-12-19 anticipated 70 Complete https://irct.ir/trial/7699 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Subjects will be randomly assigned to study groups using a random number table. 3 Chronic cervicitis. Intervention 1: Intervention group: Cervicitis Treatment Tray which is a patent made by Beijing Jinyongyuan Medical applianceco. It mainly contains Cortex Phellodendri. The herbal formulation is placed on a plastic tray which is geometrically compatible with cervix. The tray is passed through the vaginal spaculum and to be put on the cervix and removed 24 to 48 hours later. Intervention 2: Control group: cryotherapy.
public Dr Hoda Azizi
Center of Acupuncture and massage, Imam Reza Hospital
Mashhad Iran (Islamic Republic of) +98 51 3855 2188 azizih@mums.ac.ir Department of Chinese and Complementary Medicine scientific Dr Nayereh Khadem
Gynecology Research Center, Imam Reza Hospital
Mashhad Iran (Islamic Republic of) +98 51 3854 3031 khademn@mums.ac.ir Gynecology Research Center Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Developing chronic cervicitis or cervical erosion; Papanicolaou smear class 1 or 2; Normal colposcopy. Exclusion criteria: Papanicolaou smear indicating papilloma or CIN; Sensitivity to plastic materials; Cervical prolapse greater than grade 1 12 years 60 years Female N72 Inflammatory disease of cervix uteri Treatment - Drugs Treatment - Other Intervention group: Cervicitis Treatment Tray which is a patent made by Beijing Jinyongyuan Medical applianceco. It mainly contains Cortex Phellodendri. The herbal formulation is placed on a plastic tray which is geometrically compatible with cervix. The tray is passed through the vaginal spaculum and to be put on the cervix and removed 24 to 48 hours later. Control group: cryotherapy The degree of cervicitis. Timepoint: Before intervention, 48 hours after the intervention, one week after the intervention, 3 days after the end of the next menstruation and at weeks 6 and 12. Method of measurement: clinical examination of cervix (observation) and recording in the study check list. Complications. Timepoint: 48 hours after the intervention, one week after the intervention, 3 days after the end of the next menstruation and at weeks 6 and 12. Method of measurement: questionnaire. Time to treatment response. Timepoint: Before intervention, 48 hours after the intervention, one week after the intervention, 3 days after the end of the next menstruation and at weeks 6 and 12. Method of measurement: clinical examination of cervix (observation) and recording in the study check list. Mashhad University of Medical Sciences Approved 2012-03-14 Mashhad University of Medical Sciences MUM's central office, Daneshgah street, Mashhad Mashhad Iran (Islamic Republic of)