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IRCT20120125008819N3 IRCT 2022-12-12 Tehran University of Medical Sciences Comparison of the efficacy of Chamomile and Myrtus ointment in comparison with anti-hemorrhoid ointment Investigating the efficacy of herbal ointment (Chamomile and Myrtus) compared to anti-hemorrhoid ointment in the treatment of patients with hemorrhoids in a randomized clinical trial 2022-12-22 anticipated 100 Complete https://irct.ir/trial/67069 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated to the intervention and control groups using the block randomization method (block of 4). Randomization will be done centrally and before the initiation of the study by someone who is not directly involved in the recruitment of participants. Those who enroll patients in the study will not know the order of allocations. A senior researcher and clinical trial supervisor prepare a patient allocation plan based on the randomization list. Group codes of new patients will be handed over in separate sealed envelopes to the senior field researcher. So, the allocation of new patients to the groups will be hidden and will not be predictable, Blinding description: Due to the products' characteristics, it is impossible to blind the patient in this study, and the study is conducted as a single-blind study. The researcher who evaluate the outcomes will not be aware of the medication received by the patients. In other words, the assignment of patients to groups and handing the drugs to patients will be done by another researcher. 3 Hemorrhoids. Intervention 1: Intervention group: Rectal ointment containing Myrtle and Chamomile: In the intervention group, Rectus® ointment (produced by Iran Darouk Company) is used rectally, one applicator (containing one gram of the ointment) twice a day for two weeks. Every 30 grams (one tube) of Rectus® Ointment contains 8.1 grams of standardized essential oil of Myrtus communis and 0.3 grams of dried Matricaria chamomilla extract. Intervention 2: Control group: Rectal ointment of anti-hemorrhoids: Patients assigned to the control group receive anti-hemorrhoid ointment (produced by Aburihan company) rectally, one applicator (containing one gram of the ointment) twice a day for two weeks. Anti-hemorrhoid ointment contains hydrocortisone acetate (2.75 mg/g), lidocaine (50 mg/g), aluminum subacetate (35 mg/g) and zinc oxide (180 mg/g). 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 Currently, the team of researchers have not decided on this issue.
public Mona Kargar
4th floor, No: 92, South Kheradmand Junction, Karimkhan-e-zand Ave
Tehran Iran (Islamic Republic of) 1584775315 +98 21 8881 4157 mkargar@razi.tums.ac.ir Tehran University of Medical Sciences scientific Foroogh Alborzi Avanaki
Chamran highway, Bagherkhan St. ,Imam Khomeini Hospital Complex
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6119 0000 foroogh1983@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 20 to 65 years Hemorrhoid grade 1-2 based on the BPRST definition 20 years 65 years Both Hemorrhoid requiring surgery External thrombosed and strangulated hemorrhoid Anal fistula Anal fisher Anal abscess Portal hypertension Pregnancy Breastfeeding History of inflammatory bowel diseases History of gastrointestinal malignancy Severe and acute cardiovascular disease Severe and acute liver disease Renal failure Asthma Using oral corticosteroids Food or inhalation allergy needs medication therapy Use of the current research medications Rectal use of medications with the same active ingredient as the research medications K64 Hemorrhoids and perianal venous thrombosis Treatment - Drugs Treatment - Drugs Intervention group: Rectal ointment containing Myrtle and Chamomile: In the intervention group, Rectus® ointment (produced by Iran Darouk Company) is used rectally, one applicator (containing one gram of the ointment) twice a day for two weeks. Every 30 grams (one tube) of Rectus® Ointment contains 8.1 grams of standardized essential oil of Myrtus communis and 0.3 grams of dried Matricaria chamomilla extract. Control group: Rectal ointment of anti-hemorrhoids: Patients assigned to the control group receive anti-hemorrhoid ointment (produced by Aburihan company) rectally, one applicator (containing one gram of the ointment) twice a day for two weeks. Anti-hemorrhoid ointment contains hydrocortisone acetate (2.75 mg/g), lidocaine (50 mg/g), aluminum subacetate (35 mg/g) and zinc oxide (180 mg/g). Severity of hemorrhoid signs/symptoms including bleeding, persistent pain, pain during defecation, anal itching, and tenesmus. Timepoint: Before, one week, andtwo weeks after the initiation of the study. Method of measurement: The presence and severity of each of the signs/symptoms (from 1 to 10) based on taking a history. Severity of hemorrhoid symptoms considering their interferences with daily activity (Scores 0-3). Timepoint: Before and two weeks after the initiation of the study. Method of measurement: History taking ( 0=no symptoms, 1=symptoms without any effects on daily activity, 2= symptoms that affects daily activity, 3= Severe interference with daily activity). Iran Darouk Pharmaceutical-Cosmetic Company Approved 2022-10-18 Ethics committee of Imam Khomeini Hospital Complex, Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Bagherkhan St., Chamran highway Tehran Tehran Iran (Islamic Republic of)