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IRCT20220512054829N1 IRCT 2022-09-19 Kashan University of Medical Sciences Comparison of the vaginal tablet of vagiclean and metronidazole on Bacterial vaginosis Vagiclean Comparison of the vaginal tablet of vagiclean and metronidazole on Bacterial vaginosis 2022-05-21 anticipated 106 Complete https://irct.ir/trial/63498 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Considering that the treatment period of metronidazole for the treatment of bacterial vaginosis is 5 days and the treatment period of Vagiclean is 10 days. Patients of the first group who will be treated with vagiclean vaginal tablets. These tablets are in two packages of five vials, which are placed on one of the vials marked 'for use for the first five days' and on the other vial marked 'for use on the second five days'. In this way, the patients of the case group receive medicine for ten days. But in metronidazole group, patients receive placebo for 5 days. The purpose of this work was to perform complete blinding, Randomization description: Randomization is done by permuted block method so that first all 4 blocks which include two codes A and B (6 blocks) are prepared and numbers from one to 6 are assigned to each. Then, using the table of random numbers of each number 1 to 6 that is selected, the corresponding block of each code will be written (30 blocks). Based on this, a sequence of codes A and B with 80 codes (proportional to the number of samples) is prepared. Then, each of the letters A and B is randomly assigned to one of the drug and placebo groups. The same code is recorded on each drug and will remain with the formulation department until the end of the study. At the end of the study, the drug code in the form of A and B will be provided to the statistical analyst. In this way, both randomization of the study and three-way blinding will be performed, Blinding description: The drugs in both groups are in the form of vaginal tablets and are packaged in one-size-fits-all vials in the formulation section of Barij Essential Oil Pharmaceutical Company, then coded based on codes previously prepared using a random number table. 3 Bacterial vaginosis. Intervention 1: Intervention group: Vagiclean vaginal tablets. Intervention 2: Control group: Metronidazole vaginal tablets. 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 I have not decided yet - the release schedule is still unknown
public Hossein Akbari
Ghotb-e ravandi BLVD, pezeshk street
Kashan Iran (Islamic Republic of) 8715985131 +98 31 5558 9057 akbari1350_h@yahoo.com Kashan University of Medical Sciences scientific Hossein Akbari
Ghotb ravandi BLVD
Kashan Iran (Islamic Republic of) 8715985131 +98 31 5558 6057 akbari1350_h@yahoo.cim Kashan University of Medical Sciences Iran (Islamic Republic of) • Women in the age range of 18 to 49 years• Women who are sexually active• Bacterial vaginitis has been diagnosed in them. 18 years 49 years Female • Pregnancy and lactation • The presence of an intrauterine device , Use of specific medications such as immunosuppressive drugs and broad-spectrum antibiotics • Having certain diseases such as liver, nerve, heart, kidney and blood dyscrasias and diabetes Use of antiprostaglandins • Complications from drug use or drug allergies • Vaginal candidiasis and Trichomonas vaginalis N70-N77 Inflammatory diseases of female pelvic organs Treatment - Drugs Treatment - Drugs Intervention group: Vagiclean vaginal tablets Control group: Metronidazole vaginal tablets Bacterial vaginitis. Timepoint: Before intervention, 5th days of intervention, 10th days of intervention. Method of measurement: Observation of symptoms. Clinical symptoms (dysuria, itching, lower abdominal pain, burning, dysparonia, foul-smelling discharge, vaginal discharge). Timepoint: Before intervention, 5th days of intervention, 10th days of intervention. Method of measurement: Observation of symptoms. Positive Amsel criteria (KOH test, PH test, clinical signs, smear test). Timepoint: Before intervention, 5th days of intervention, 10th days of intervention. Method of measurement: results of laboratory symptoms. Dysuria, itching, lower abdominal pain, burning, dysparonia, foul-smelling discharge, vaginal discharge. Timepoint: Before intervention, 5th day of intervention, 10th day of intervention. Method of measurement: Clinical interview with the patient. Positive Amsel criteria (KOH test, PH test, clinical signs, smear test). Timepoint: Before intervention, 5th day of intervention, 10th day of intervention. Method of measurement: Observation of symptoms. Barij essnce pharmaceutical company Approved 2022-05-14 Ethics Committee in Biomedical Research, Kashan University of Medical Sciences Ghotb ravandi BLVD, pezeshk street Kashan Isfehan Iran (Islamic Republic of)