]>
IRCT20210325050769N2 IRCT 2021-12-27 Bagheiat-allah University of Medical Sciences Evaluation of the effectiveness of flavonoid lotion in the treatment of hemorrhoids Evaluation of the efficacy and safety of an innovative flavonoid lotion in patients with hemorrhoid; A Randomized Clinical Trial 2020-04-20 anticipated 100 Complete https://irct.ir/trial/57224 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the study, the block method is used with individual randomization unit and Excel software (to generate random block sequences). The printed blocks will be placed in a sealed envelope and the researcher will randomly pick up one of them and assign the patients to the intervention or control group. 2-3 Hemorrhoids. Intervention 1: Intervention group: Patients in this groups use the herbal lotion topically/rectal, twice a day for one month. Each 100 mg of produced flavonoid lotion has 70% flavonoid content (1/2 honey propolis, 1/2 olive oil) and 30% Excipient as underlying solvent. Intervention 2: Control group: Patients in this groups use the anti-hemorrhoid ointment topically/rectal, twice a day for one month. Iran Najo anti-hemorrhoid ointment is available routinely in pharmacies and each 100 grams of it contains hydrocortisone acetate (0.275 grams), lidocaine (5 grams), aluminum subacetate (3.5 grams) and zinc oxide (18 grams). Yes - There is a plan to make this available What will be shared: All data can be shared after un-identification of individuals When: Access period starts 6 months after the results are published To whom: The data will be available to researchers working in academic centers as well as to industry professionals Conditions: Statistical analyzes on data are allowed for scientific and research use after obtaining permission from the project manager Where to obtain: For data and documentation, refer to the Research Center for Gastroenterology and Liver Diseases and Dr. Mohammad Heiat(Research Director of the Research Center) How to obtain: After receiving a written request from researchers working in academic and scientific institutions as well as people working in industry by the Baqiyatallah Research Center for Gastroenterology and Liver Disease and reviewing the application in the Research Council of the Research Center, the documents or data files will be delivered to the applicant after about 10 days. Comments:
public Sara Razdar
Vanak sq, Mollasadra street, Southern sheikhbahaei street
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8861 2072 Srazdar@gmail.com Bagheiat-allah University of Medical Sciences scientific Sara Razdar
Vanak sq, Mollasadra street, Southern sheikhbahaei street
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8861 2072 Srazdar@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients with grade 2 or higher hemorrhoids Age range 18-75 Lack of drug allergy to lotion Lack of confounding underlying disease such as diabetes Patient satisfaction 18 years no limit Both Patient dissatisfaction Higher or lower grades of disease Presence of drug allergy to plant Lotion Existence of confounding underlying disease such as diabetes K64 Hemorrhoids and perianal venous thrombosis Treatment - Drugs Treatment - Drugs Intervention group: Patients in this groups use the herbal lotion topically/rectal, twice a day for one month. Each 100 mg of produced flavonoid lotion has 70% flavonoid content (1/2 honey propolis, 1/2 olive oil) and 30% Excipient as underlying solvent. Control group: Patients in this groups use the anti-hemorrhoid ointment topically/rectal, twice a day for one month. Iran Najo anti-hemorrhoid ointment is available routinely in pharmacies and each 100 grams of it contains hydrocortisone acetate (0.275 grams), lidocaine (5 grams), aluminum subacetate (3.5 grams) and zinc oxide (18 grams). Hemorrhoid grade. Timepoint: weekly. Method of measurement: With history and physical examination. Rectal bleeding. Timepoint: Weekly. Method of measurement: With history and physical examination. Anal pain. Timepoint: Weekly. Method of measurement: With history and physical examination. Incomplete defecation. Timepoint: Weekly. Method of measurement: With history and physical examination. Anal irritation. Timepoint: Weekly. Method of measurement: With history and physical examination. Anal discharge. Timepoint: weekly. Method of measurement: With history and physical examination. Anal discomfort. Timepoint: Weekly. Method of measurement: With history and physical examination. Bagheiat-allah University of Medical Sciences Approved 2020-02-18 Research Ethics Committees of Baqiyatallah Hospital Vanak sq, Mollasadra street, Southern sheikhbahaei street Tehran Tehran Iran (Islamic Republic of)