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IRCT20190728044356N1 IRCT 2020-12-07 Ahvaz University of Medical Sciences Clinical trial on comparing the effect of vaginal Shallomine containing the pure fraction of shallot extract and clotrimazole in treatment of candidal vaginitis Assessing the effect of vaginal Shallomine containing pure fraction of shallot extract and clotrimazole in treatment of candidal vaginitis 2020-09-22 anticipated 30 Complete https://irct.ir/trial/51040 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This randomized controlled trial was designed in two parallel groups using a random block table of 8 blocks of 4. Random sequences were generated using WinPEPI (version 11.43) and the ratio assignment was 1: 1. For example, block 1: 1: A 2: A 3: B 4: B The codes are the letters A and B, the letter A being the test drug, and the letter B the control. The drugs were numbered sequentially, but the patient and physician did not know the codes. Codes are assigned to patients in the order of patient entry. After the results are announced, the numbers are matched by the epidemiologist with the codes and it is determined which number is related to the test and which number is related to the control. 2-3 Condition 1: Candidiasis. Condition 2: Candidiasis of vulva and vagin. Intervention 1: Intervention group: Shalomine, 2 cc, deep vaginal inoculation with sterile syringe, twice daily for 5 days. Intervention 2: Intervention group: Clotrimazole, daily for one week. 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 There is no more information
public Sousan Akrami
Department of Microbiology, Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 15794- 61357 +98 61 3373 8283 sahm647094@gmail.com Ahvaz University of Medical Sciences scientific Mansour Amin
Department of Medical Microbiology, Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 15794- 61357 +98 61 3373 8204 mnsamin@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) aged between 18 and 50 years Be married Have 1 spouse Have consent to participate in the study Not allergic to herbal medicines Not allergic to clotrimazole Be literate 18 years 50 years Female They have been taken antibiotics and corticosteroids for the past two weeks, according to the participant Have any sores or lumps in the cervix based on observation with speculum Present use of other herbal medicines Have abnormal uterine bleeding B37 B37.3 Candidiasis Candidiasis of vulva and vagina Treatment - Drugs Treatment - Drugs Intervention group: Shalomine, 2 cc, deep vaginal inoculation with sterile syringe, twice daily for 5 days Intervention group: Clotrimazole, daily for one week Percentage of people with candidal vaginitis. Timepoint: Examination of Candida in the patient's vaginal discharge before the intervention and one week after taking the drug. Method of measurement: culture and Laboratory diagnosis of Candida. Ahvaz University of Medical Sciences Approved 2020-10-26 Ethics Committee in Research of Ahvaz Jundishapur University University City, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences and Health Services, Ground Floor Ahvaz Khouzestan Iran (Islamic Republic of)