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IRCT20231017059753N1 IRCT 2023-12-20 Yasouj University of Medical Sciences Comparison of the effect of Hypericum perforutum Vaginal gel and Clotrimazole Vaginal cream on Vaginal Candida albicans infection: A double-blind randomized clinical trial Comparison of the effect of Hypericum perforutum Vaginal gel and Clotrimazole Vaginal cream on Vaginal Candida albicans infection: A double-blind randomized clinical trial 2023-11-22 anticipated 80 Complete https://irct.ir/trial/73233 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be in the form of random block sampling based on the purpose and according to the study entry criteria. We consider the block size to be 5. Therefore, based on the sample size, we will have 20 blocks. When sampling starts, the first block will be randomly assigned one of the codes A or B. Based on the received code of the first block, the second code will be sent to the second block, the first code will be sent to the third block, the second code will be sent to the fourth block, and so on until the end of the 20th block, Blinding description: Hypericum perforutum vaginal gel and Clotrimazole vaginal cream have already been compared by the pharmacist in terms of appearance, color, size, smell and coded (A and B). The researcher, the service provider, the data analyst and the patient are unaware of the type of drug used, and only the pharmacist will be aware of this coding. 3 Candida vaginitis. Intervention 1: The intervention group will use the vaginal gel of gerbera prepared by the pharmacist with a concentration of 3%. After manufacturing, it is poured into sterilized tubes and placed in a box with 5 applicators. Each applicator contains 5 grams of cream, which the patient is instructed to use every night for 5 nights. Explanations regarding not using other drugs and antibiotics and not using vaginal douche and other vaginal drugs during the treatment period will be given to the intervention group. Intervention 2: Control group: The control group will be clotrimazole vaginal cream. Tubes of Clotrimazole Vaginal Cream and Calendula Gel will match in terms of color, smell, size and shape. Each applicator contains 5 grams of cream, which the patient is instructed to use every night for 5 nights. Explanations regarding not using other drugs and antibiotics and not using vaginal douche and other vaginal drugs during the treatment period will be given to the control group. 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 on this yet
public Leila Bozorgian
Shahid Jalil Street, Educational Campus
Yasuj Iran (Islamic Republic of) 7591994799 +98 74 3323 0240 liela.bozorgian1@gmail.com Yasouj University of Medical Sciences scientific Leila Bozorgian
Shahid Jalil Street, Educational Campus
Yasuj Iran (Islamic Republic of) 7591994799 +98 74 3323 0240 liela.bozorgian1@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) 1- Women of reproductive age (18-49)- 2- Presence of cheesy vaginal discharge and doctor's confirmation 3- Complaints of burning, itching and swelling and pain in the vulva and vagina 4- Absence of other vaginal infections 5- Willingness to participate in the study 6- Women with sexual partners 18 years 49 years Female 1- Lactating women 2- Pregnant women 3- Women who smoke 4- The possibility of starting menstruation in the next 10 days 5- Having abnormal vaginal bleeding at the time of sampling 6- Having intercourse in the last 24 hours 7- Washing the vagina and using vaginal medicine in the last 48 hours 8- Having a history of any type of transplantation and using immunosuppressive drugs and broad-spectrum antibiotics, hormonal drugs and combined contraceptive pills, anti prostaglandins and anticoagulant drugs in the last month, and antiepileptic and migraine drugs or women with Heart and kidney diseases or sexually transmitted diseases. 9- History of Candida infection in the last 6 months and its treatment 10- History of candidal vaginitis N76.1 Subacute and chronic vaginitis Treatment - Drugs Placebo The intervention group will use the vaginal gel of gerbera prepared by the pharmacist with a concentration of 3%. After manufacturing, it is poured into sterilized tubes and placed in a box with 5 applicators. Each applicator contains 5 grams of cream, which the patient is instructed to use every night for 5 nights. Explanations regarding not using other drugs and antibiotics and not using vaginal douche and other vaginal drugs during the treatment period will be given to the intervention group. Control group: The control group will be clotrimazole vaginal cream. Tubes of Clotrimazole Vaginal Cream and Calendula Gel will match in terms of color, smell, size and shape. Each applicator contains 5 grams of cream, which the patient is instructed to use every night for 5 nights. Explanations regarding not using other drugs and antibiotics and not using vaginal douche and other vaginal drugs during the treatment period will be given to the control group. Itching. Timepoint: Results will be measured ten days to two weeks after the end of the treatment period. Method of measurement: The way to measure the variable will be through a laboratory test and also a researcher-made questionnaire of clinical symptoms. Burning. Timepoint: Results will be measured ten days to two weeks after the end of the treatment period. Method of measurement: The way to measure the variable will be through a laboratory test and also a researcher-made questionnaire of clinical symptoms. Vaginal pain. Timepoint: Results will be measured ten days to two weeks after the end of the treatment period. Method of measurement: The way to measure the variable will be through a laboratory test and also a researcher-made questionnaire of clinical symptoms. Inflammation. Timepoint: Results will be measured ten days to two weeks after the end of the treatment period. Method of measurement: The way to measure the variable will be through a laboratory test and also a researcher-made questionnaire of clinical symptoms. Cheesy secretions. Timepoint: Results will be measured ten days to two weeks after the end of the treatment period. Method of measurement: The way to measure the variable will be through a laboratory test and also a researcher-made questionnaire of clinical symptoms. Satisfaction with treatment. Timepoint: One week to ten days after the intervention. Method of measurement: questionnaire. Vice President of Research and Technology of Yasouj University of Medical Sciences Yasouj University of Medical Sciences Vice President of Research and Technology of Yasouj University of Medical Sciences Approved 2023-10-31 Ethics Committee of Yasuj University of Medical Sciences Shahid Motahari St., Yasouj University of Medical Sciences, Research Assistant Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)