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IRCT20200721048159N7 IRCT 2023-08-16 Khoram-Abad University of Medical Sciences Evaluation of the Effect of Scrophularia Striata Extract on Bacterial Vaginitis Evaluation of the Effect of Vaginal Cream of Aqueous Extract from Aerial Part Scrophularia Striata on Bacterial Vaginitis in Married Women with Aged 18 to 45 Years: a Triple Blind, Randomized, Controlled Clinical Trial 2023-09-23 anticipated 120 Complete https://irct.ir/trial/68787 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be selected consecutively and easily from the eligible people of the studied community and will be assigned to the fore studied groups using the random block method. This method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization guarantees that there is no significant imbalance between the groups during randomization, and at certain points the number of participants is each group is equal. For this method, the size of each block must be determined first (example block of four). Then write the list of blocks and assign numbers to them (AABB(1)-ABAB(2)-ABBA(3)-BBAA(4)-BABA(5)-BAAB(6)) Then choose random number between 1 and 6 (for example, 1,4,5 and...) and finally specifying the treatment allocation list based on the previous random numbers(AABB-BBAA-BABA...), Blinding description: The sample will be studied in a three-way blind way, so that the patient, the researcher, and the statistical analyst will not know which th ey are in arm. In this study, each group of drugs will be specified as boxes A and B will be provided to the researcher, and patient will randomly choose one of the boxes after visiting. 3 Bacterial vaginitis. Intervention 1: Intervention group:They uses 0/75% metronidazol vaginal gel along with vaginal cream containing 5% aqueous extract of the Scrophularia Striata plant for 5 day and 12 hours apart. Intervention 2: Control group: they uses 0/75% metronidazol vaginal gel along with placebo vaginal cream for 5 day and 12 hours apart. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Forouzan Ahmadpour
Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road, Khorramabad, Lorestan, Iran
khorramabad Iran (Islamic Republic of) 6813833946 +98 66 3312 0239 ahmadpourforoz@yahoo.com Khoram-Abad University of Medical Sciences scientific Forouzan Ahmadpour
Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road, Khorramabad, Lorestan, Iran
Khorramabad Iran (Islamic Republic of) 6813833946 +98 66 3312 0239 ahmadpourforoz@yahoo.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Women in the age range of 18 to 45 years Being married Having at least 3 of the 4 amsel criteria Having informed consent BMI less than 30 18 years 45 years Female Inability of the patient to complete the treatment protocol presence if other vaginitis along with bacterial vaginitis The patients lack of consent to continue participating in the study Abnormal vaginal bleeding Pregnancy Other systemic diseases History of smoking, drugs or alcohol Use of cryothetapy during the six weeks before the study History of frequent infections (4 or more than 4 times a year) History of allergy to medicinal herbs and metronidazol Using antibiotics in the last two weeks Using vaginal creams, suppositories or shower in the last 48 hours N76.0 Acute vaginitis Treatment - Drugs Treatment - Drugs Intervention group:They uses 0/75% metronidazol vaginal gel along with vaginal cream containing 5% aqueous extract of the Scrophularia Striata plant for 5 day and 12 hours apart. Control group: they uses 0/75% metronidazol vaginal gel along with placebo vaginal cream for 5 day and 12 hours apart. Evaluation of Amsels clinical criteria. Timepoint: Evaluation of clinical symptoms based on the Amsels criteria at the beginning of the study and 2 to 7 days after the end of the treatment period. Method of measurement: Patient examination and sampling. Khoram-Abad University of Medical Sciences Approved 2023-01-18 Ethics Committee of Lorestan University of Medical Sciences Office of Research Ethics Committee, Vice Chancellor for Research and Technology, Lorestan University of Medical Sciences, Pardis University Complex, 3 km of Khorramabad Road, Khorramabad, Lorestan, Iran Khorramabad Lorestan Iran (Islamic Republic of)