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IRCT20190915044780N1 IRCT 2020-05-09 Tehran University of Medical Sciences Terminalia chebula Therapeutic effects in Patients With Symptomatic Hemorrhoids Terminalia chebula Therapeutic effects in Patients With Symptomatic Hemorrhoids in reducing hemorrhage 2020-06-21 anticipated 42 Complete https://irct.ir/trial/42256 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization In this method, we use simple randomization models, such as computer randomization methods, and place each patient in the intervention or control group, Blinding description: In addition to routine treatment, patients are given ointments that patients do not know about the type of ointment (which may contain the active ingredient of Terminalia chubula or just placebo). 3 Hemorrhoids. Intervention 1: Intervention group: In the intervention group standard treatment (lifestyle modification including high fiber diet, intake of more liquids, forcing during excretion, personal hygiene to reduce itching of the anal area) is given with the ointment containing the active ingredient of Terminalia chubula. The way to use the ointment is to put a teaspoon of ointment on your finger and apply it to the area of ​​your anus. Do this twice a day for three weeks. All the steps of using the ointment will be fully explained to the patients. In this study we use a dose of 5% ointment of Terminalia chubula. The only difference in this study is to evaluate the efficacy of the plant only The pharmacokinetics and drug release rate will be evaluated in future studies. Intervention 2: Control group: The control group received standard treatment (lifestyle modification including high fiber diet, intake of more liquids, forcing during excretion, personal hygiene to reduce anal itching) with ointment containing fixed substance. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome, is shared. When: The access period begins 6 months after the results are published. To whom: It will only be available to researchers working in academic and scientific institutions Conditions: The data can be used for further documentation and study. In the case of data analysis, the Person responsible for updating data is responsible for delivering the data depending on the type of decision. Where to obtain: To access the data, the persons can send an email message to the project manager. dr zabihi email: hzabihim@tums.ac.ir How to obtain: Depending on the type of application, the applicant arrives up to 2 months after the application has been submitted. Comments:
public Hossein Zabihi Mahmoudabadi
Sina Hospital, Hassan Abad Square, Imam Khomeini
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6675 7001 hzabihim@tums.ac.ir Tehran University of Medical Sciences scientific hossein zabihi mahmoudabadi
Sina Hospital, Hassan Abad Square, Imam Khomeini Avenue
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6675 7001 hzabihim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Internal hemorrhoids Patient hemorrhoids grade one, two and three Having informed written consent to participate in the study no limit no limit Both Internal Grade Four Hemorrhoids external hemorrhoid Systemic disease anal fissure anal abscess anal fistula cirrhosis Inflammatory bowel disease (IBD) Those who have not received the full course of treatment or are experiencing medical complications. K64 Hemorrhoids and perianal venous thrombosis Treatment - Drugs Placebo Intervention group: In the intervention group standard treatment (lifestyle modification including high fiber diet, intake of more liquids, forcing during excretion, personal hygiene to reduce itching of the anal area) is given with the ointment containing the active ingredient of Terminalia chubula. The way to use the ointment is to put a teaspoon of ointment on your finger and apply it to the area of ​​your anus. Do this twice a day for three weeks. All the steps of using the ointment will be fully explained to the patients. In this study we use a dose of 5% ointment of Terminalia chubula. The only difference in this study is to evaluate the efficacy of the plant only The pharmacokinetics and drug release rate will be evaluated in future studies. Control group: The control group received standard treatment (lifestyle modification including high fiber diet, intake of more liquids, forcing during excretion, personal hygiene to reduce anal itching) with ointment containing fixed substance. Severity of hemorrhage. Timepoint: At the beginning of treatment and then weekly for 3 weeks. Method of measurement: questionnaire. Tehran University of Medical Sciences Approved 2019-09-04 Institutional Research Ethics Committee School of Medicine- Tehran University of Medical Sciences No. 23, 16 Azar Ave., Keshavarz Blvd.,Tehran Tehran Tehran Iran (Islamic Republic of)