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IRCT20210508051222N1 IRCT 2021-06-30 Esfahan University of Medical Sciences Comparison of the effect of Harpagophytum procumbens and topical Hydrocortisone in improving genital skin inflammation in patients with candidiasis Comparison of the effect of Harpagophytum procumbens and topical Hydrocortisone in improving genital skin inflammation in patients with candidiasis 2021-07-23 anticipated 60 Complete https://irct.ir/trial/56136 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done with a simple random method and creating random values between zero and one in spss software. Values equal or less than 0.5 are assigned to group A and values greater than 0.5 are assigned to group B. Then, a person who was not a member of research team encodes 60 envelopes (based on the codes obtained in the randomization method) and determines the list of codes. New treatment or standard (conventional) treatment will be written in the envelope. One envelope will be given to each eligible patient according to their order of entry in the clinic to give to the specialist. The clinician will prescribe and make the necessary recommendations for each patient based on the grouping done. The researchers are blinded to patients group, Blinding description: The secretary introduces the patients to the clinician based on the random allocated groups. Clinician provides treatment for each group according to their grouping. The researcher in collaboration with the clinician monitors patient’s medication use. After collecting the data of the questionnaire that was completed by the patients, the data is given to the statistical specialist for analysis. Statistical specialist is blinded to patients group. 3 Candidal vulvovaginitis. Intervention 1: Intervention group: The weight of each ointment used in this group is 20 to 30 grams, which includes cold cream base made by Naghsh Jahan Company, Dr. Shahtalebi, and contains 20% of aloe vera gel extracted from the leaves, clotrimazole 2%, idoquinol 1% and 480 mg extract of Harpagophytum procumbens. Which is for external use and 2 times a day for a week. Intervention 2: Control group: Intervention group: The weight of each ointment used in this group is 20 to 30 grams, which includes cold cream base made by Naghsh Jahan Company, Dr. Shahtalebi, and contains 20% of aloe vera gel extracted from the leaves, clotrimazole 2%, idoquinol 1% and Hydrocortisone sodium succinate 1% . Which is for external use and 2 times a day for a 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 Reyhaneh Daryabeigi
No119, Alborz alley, Hossein zade alley, N7 Alley, jahad Aven.
Isfahan Iran (Islamic Republic of) 8183886761 +98 31 3236 4028 tahereh.khalili@med.mui.ac.ir Esfahan University of Medical Sciences scientific Reyhaneh Daryabeigi
No119, Alborz alley, Hossein zade alley, N7 Alley, jahad Aven.
Isfahan Iran (Islamic Republic of) 8183886761 +98 31 3236 4028 tahereh.khalili@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Having an age range of fifteen to fifty years Being married Signs and symptoms of candidate vaginitis in the interview 15 years 50 years Female Use of broad-spectrum antibiotics in the last two weeks Use of oral and vaginal medications related to the treatment of genital infections during the last two weeks Any allergies to the drug compounds used in the research Trichomonas vaginitis B37.3 Candidiasis of vulva and vagina Treatment - Drugs Treatment - Drugs Intervention group: The weight of each ointment used in this group is 20 to 30 grams, which includes cold cream base made by Naghsh Jahan Company, Dr. Shahtalebi, and contains 20% of aloe vera gel extracted from the leaves, clotrimazole 2%, idoquinol 1% and 480 mg extract of Harpagophytum procumbens. Which is for external use and 2 times a day for a week. Control group: Intervention group: The weight of each ointment used in this group is 20 to 30 grams, which includes cold cream base made by Naghsh Jahan Company, Dr. Shahtalebi, and contains 20% of aloe vera gel extracted from the leaves, clotrimazole 2%, idoquinol 1% and Hydrocortisone sodium succinate 1% . Which is for external use and 2 times a day for a week. The amount of burning of external genitalia. Timepoint: Before the start of the study and 7 days after taking the drug. Method of measurement: 5-points checklist. The amount of itching of external genitalia. Timepoint: Before the start of the study and 7 days after taking the drug. Method of measurement: 5-points checklist. Amount of redness and swelling of the external genitalia. Timepoint: Before the start of the study and 7 days after taking the drug. Method of measurement: 5-points checklist. Esfahan University of Medical Sciences Approved 2021-05-04 Ethics Committee of Isfahan University of Medical Sciences No. 119, Alborz Alley, 7th Alley, Hosseinzadeh Alley, Jahad St. isfahan Isfehan Iran (Islamic Republic of)