The effect of Henna (Lawsonia inermis) vaginal suppository combined with antibiotic therapy in the treatment of cervicitis : A Randomized Triple-blind Clinical Trial

Comparison the efficacy of oral Azithromycin, Cefixime and Metronidazole with vaginal suppository of Henna oil based in women with cervicitis

This is a triple-blind randomized clinical trial, phase III, in which 92 eligible patients will be randomly assigned to the intervention and control groups.

Patients with cervicitis referred to Shahid Sadoughi Hospital in Yazd and Ardakan School of Persian Medicine will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups. This trial will be triple-blinded so that neither patients nor the examining physician nor statistical analysts will be aware of the intervention.

Inclusion criteria: non-menopausal women ; cervicitis; married. Exclusion criteria: menopause; pregnancy; breastfeeding; any addiction; observe herpes sores or genital warts on examination and/or HPV positive test; concomitant use of antibiotic or herbal remedies for her disease (do not take antibiotic, immunosuppressive drugs or vaginal medications for 14 days before study); history of allergies to henna

Intervention group: Cefexime tab 400 mg single dose, azithromycin tab 1 mg single dose and metronidazole tab 500 mg every 12 hours for 5 days and vaginal suppository of Henna oil based every night for a week and couples treated with cefixime 400 mg single dose, azithromycin 1 mg single dose and 4 metronidazole 500 mg single dose. Control group: Cefexime 400 mg single dose, azithromycin 1 mg single dose and metronidazole 500 mg every 12 hours for 5 days and basic suppository for 1 week, 1 each night and spouses similar to the intervention group.

Cervical ulcer size; Discharge; Irritation; Dyspareunia; Postcoital bleeding; Friability

Since the sampling was done during the COVID-19 crisis and the possibility of further loss of patients in the process، we increased the number of patients.

Patients are randomly assigned to the intervention and control groups through random sequences generated by random allocation software.

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.