]>
IRCT20210312050686N1 IRCT 2021-07-13 Yazd University of Medical Sciences Effect of Henna vaginal suppository combined with antibiotic therapy in the treatment of cervicitis The effect of Henna (Lawsonia inermis) vaginal suppository combined with antibiotic therapy in the treatment of cervicitis : A Randomized Triple-blind Clinical Trial 2021-08-06 anticipated 92 Complete https://irct.ir/trial/55090 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The effect of the studied drug has been extracted from reliable sources of traditional Iranian medicine, Randomization description: Patients are randomly assigned to the intervention and control groups through random sequences generated by random allocation software, Blinding description: This is a triple-blind controlled clinical trial. The pharmacist identifies the drug and the placebo with two types of codes A and B. Researcher, patients, and statistical analysts do not know whether A or B is a drug or a placebo. Therefore, the researcher, patients and statistical analyst are kept blind until the end of the study. At each visit, patients are randomly assigned to group A or B. People will not know how to distribute the drug and the drugs are available to patients in opaque colored bottles with a similar shape and sealed according to the codes defined randomly. The tools and materials needed to make the placebo will be exactly the same as the medicine except that only the active ingredient is removed from the placebo. 3 Cervicitis. Intervention 1: Intervention group: Cefixime 400 mg single dose, azithromycin 1 mg single dose and metronidazole 500 mg every 12 hours for 5 days and vaginal suppository of Henna oil based every night for a week and partner cefixime 400 mg single dose, azithromycin 1 mg single dose and 4 metronidazole 500 mg. Intervention 2: Control group: Cefixime 400 mg single dose, azithromycin 1 mg single dose and metronidazole 500 mg every 12 hours for 5 days and placebo one every night for a week and partner Cefixime 400 mg single dose, Azithromycin 1 mg single dose and 4 metronidazole 500 mg. 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 There is no more information.
public Naeeme Nabi Meybodi
Yazd University of Medical Sciences, Bahonar square
Yazd Iran (Islamic Republic of) 8916978477 +98 35 3724 0171 dvc.research@ssu.ac.ir Yazd University of Medical Sciences scientific Razieh Nabi Meybodi
Yazd University of Medical Sciences, Bahonar Square
Yazd Iran (Islamic Republic of) 8916978477 +98 35 3724 0171 r.nabimeybodi@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) married non-menopausal women who confirme cervicitis through colposcopy and biopsy with symptoms such as refractory vaginal discharge, postcoital bleeding (PCB), abnormal uterine bleeding (AUB), abnormal Pap smear, or abnormal appearance of the cervix on examination with a speculum. 21 years 50 years Female being pregnant lactating involved in any addiction observing herpes sores or genital warts on examination and/or HPV positive test dysplasia or cancer of cervix intake of herbal products or medications that influence cervicitis like antibiotics, immunosuppressive drugs or vaginal medications over 2 weeks before the commencement of the study history of allergies to Henna Inflammato N72 Treatment - Drugs Placebo Intervention group: Cefixime 400 mg single dose, azithromycin 1 mg single dose and metronidazole 500 mg every 12 hours for 5 days and vaginal suppository of Henna oil based every night for a week and partner cefixime 400 mg single dose, azithromycin 1 mg single dose and 4 metronidazole 500 mg Control group: Cefixime 400 mg single dose, azithromycin 1 mg single dose and metronidazole 500 mg every 12 hours for 5 days and placebo one every night for a week and partner Cefixime 400 mg single dose, Azithromycin 1 mg single dose and 4 metronidazole 500 mg Mean of ulcer size. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Clinical examination. Vaginal discharges. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Visual Analogue Scale. Irritation. Timepoint: Before intervention, after intervention. Method of measurement: Visual Analogue Scale. Dyspareunia. Timepoint: Before intervention, after intervention. Method of measurement: Yes- no. Postcoital bleeding. Timepoint: Before intervention, after intervention. Method of measurement: Yes- no. Friability. Timepoint: Before intervention, after intervention. Method of measurement: Yes- no. Yazd University of Medical Sciences Approved 2020-10-27 Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences Yazd University of Medical Sciences, Bahonar Square, Yazd Yazd Yazd Iran (Islamic Republic of)