Randomized, double blind, positive drug parallel comparison, multi-centre clinical trial to assess the Efficacy and Safety of Clindamycin palmitate hydrochloride dispersible tablet for the treatment of bacterial vaginosis
Treatment group: Clindamycin palmitate hydrochloride dispersible tablet . Control group: Metronidazole Tablet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
300mg, oral after meal, twice daily, a total of 7days
400mg, oral after meal , twice daily, a total of 7days
Peking University first hospital
Beijing, China
RECRUITINGNugent score
score of Vaginal secretions for Gram stain
Time frame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
The pH of vaginal secretions;
pH value
Time frame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
Leucorrhea routine examination
Vaginal cleanliness
Time frame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
Itching score
The severity of vulvar itching
Time frame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
Vaginal secretions
The amount of secretions
Time frame: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.