Effect of combined vaginal cream (including honey, olive oil, and propolis) versus placebo with antibiotic therapy on improvement of cervicitis symptoms: a double-blind randomized clinical trial

To assess the effect of combined vaginal cream (including honey, olive oil, and propolis) versus placebo with antibiotic therapy on improvement of cervicitis symptoms.

This is a double-blind randomized clinical trial, phase III, in which 66 eligible patients will be randomly assigned to the intervention and control groups

The eligible patients with cervicitis referring to the Health Centers in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.

Inclusion criteria: Age of 18 to 44 years, Cervicitis, Married, Exclusion criteria: Pregnancy or breastfeeding, Taking antibiotic or immunosuppressive medications to vaginal drugs in the past 2 weeks, Abnormal uterine bleedings, Abnormal Pop-smear test in the past 12 months, Repeated vaginal shower, Alcohol consumption, Liver, renal, hematologic, or central nerves system diseases or diabetes or immunodeficiency syndrome

Intervention group: Tablet azithromycin 1 g single-dose and tab cefixime 400 mg single-dose and tablet metronidazole 500 mg daily for 7 days patient and her husband plus combined vaginal cream (containing honey, olive, propolis) every night for 14 nights Control group: Tablet azithromycin 1 g single-dose and tab cefixime 400 mg single-dose and tablet metronidazole 500 mg daily for 7 days patient and her husband plus placebo vaginal cream (containing oil) every night for 14 nights

Primary outcome: Symptoms of cervicitis

The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.

The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.