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IRCT20120414009463N61 IRCT 2020-12-02 Tehran University of Medical Sciences Comparison of the effect of curcumin tablets with metronidazole tablets on the treatment of bacterial vaginosis Comparison of the effect of curcumin tablets with metronidazole tablets on the treatment of bacterial vaginosis 2019-12-22 anticipated 90 Complete https://irct.ir/trial/51341 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling of this study will be random using block method. In this way, all eligible people enter the study after providing complete explanations and obtaining informed consent and are randomly placed in one of the two intervention or control groups with a quadruple blocking method. In this way, we will consider the letter A for the intervention group and the letter B for the control group. Then write all the permutation compounds of the letters A, A and B, B, which are 6 combinations (AABB for combination 1, ABBA for combination 2, etc.) and from combinations 1 to 6, a combination will be randomly selected. . For example, if combination 1 is selected, it means that the first and second people will be in the intervention group and the third and fourth people will be in the control group. Sampling will continue until the desired number of samples in each group is reached. N/A Condition 1: Bacterial vaginosis treatment. Condition 2: Vaginosobacterial treatment with nanocurcumin 40 capsules. Intervention 1: .Intervention group: Study participants who meet the inclusion criteria are treated with 40 nanocurcumin capsules every 12 hours for one week. Intervention 2: Control group: Participants in the study who meet the inclusion criteria are treated with metronidazole 500 tablets every 12 hours for one week. No - There is not a plan to make this available Justification or reason for not sharing IPD is I have not decided yet - the release schedule is not clear yet
public Zahra Behboodi Moghadam
School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4227 Behboodi@tums.ac.ir Tehran University of Medical Sciences scientific Sakine Mohammadi
School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4227 sm_golyas99@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) 1- Age 18- 49 years 2. Being married 3 - Do not be menopause 4 - No pregnancy and lactation 5- proof of bacterial vaginosis 6- Not having allergies to curcumin (turmeric) or other medicinal plants 7. No history of known chronic disease 8. Not using herbal medicines and chemicals related to the treatment of genital infections during the last two weeks 9 - No active gastrointestinal ulcers and also no bile problems and gallstones 18 years 49 years Female 1.Pregnancy during treatment 2. The presence of other vaginal infections 3. Complications or allergies to curcumin 4. The reluctance of the participant to continue the research 5 - not following the correct method of treatment (forgetting to take medicine for more than one night) 6- Use of systemic antibiotics to treat non-bacterial systemic infection during treatment Treatment - Drugs Treatment - Drugs .Intervention group: Study participants who meet the inclusion criteria are treated with 40 nanocurcumin capsules every 12 hours for one week. Control group: Participants in the study who meet the inclusion criteria are treated with metronidazole 500 tablets every 12 hours for one week. The primary outcome is the percentage of people who have improved after taking oral curcumin tablets to treat bacterial vaginosis. Timepoint: Periods of disease evaluation, before the intervention and two weeks after starting metronidazole and curcumin tablets. Method of measurement: Existence of three of Amsel's four standard signs. medical University Tehran Approved 2019-12-22 Ethics Committee of Tehran University of Medical Sciences and Health Services Keshavarz Boulevard, corner of Quds Street, central building Tehran Tehran Iran (Islamic Republic of)