]>
IRCT20100107003014N20 IRCT 2018-10-28 Vice chancellor for research and technology, Mazandaran University of Medical Sciences Effect of hydroalcoholic extract of Ruscus hyrcanus in treatment of chronic venous insufficiency Study of therapeutic effects of ointment containing hydro alcoholic extract of root and rhizome of Ruscus hyrcanus woronow in patients with chronic venous insufficiency (Grade 1 and 2 hemorrhoids); a randomized, double blind, controlled with placebo study. 2018-09-11 anticipated 60 Complete https://irct.ir/trial/31108 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done through a random number table, Blinding description: Ointments made in "placebo" and "Drug" groups, are numbered in the list by the supervisor. After prescribing by the physician, the code of prescribed ointment will be entered into the questionnaire. Physician, Patient and investigator are not aware of the type of ointment. 3 Condition 1: Hemorrhoids grade 1. Condition 2: Hemorrhoids grade 2. Intervention 1: Intervention group: Ruscus extract 2% ointment/ 2 times daily/ 1 cm of the ointment/ For one month. Intervention 2: Control group: ointment formolation without any drugs/ 1 cm of the ointment/ For one month. 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 not any more information
public Fateme Shamalizade Baii
Payambar azam university complex, Mazandaran University of Medical Sciences, Faculty of pharmacy, Km 18 Khazar abad road, Sari, Mazandaran, Iran
sari Iran (Islamic Republic of) 4815733971 +98 11 3354 3083 sala@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr. Shahram Ala
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 18 Khazar Abad Road, Sari, Mazandaran, Iran
sari Iran (Islamic Republic of) 4815733971 +98 11 3354 3083 sala@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) at least 18 years old first and second untreated hemorrhoids 18 years no limit Both History of allergic reactions to plants in this family Pregnancy and Lactation History of any anorectal surgery and non-pharmacological treatment of hemorrhoids Ascetic, IBD, Inflammation and any illness that causes rectal bleeding Thrombosis or external hypersensitivity of the hemorrhoid Fissure or anal fistula Hemorrhoids Grade 3 and 4 Anal abscess, port hypertension Renal failure and any malignancy K64.0 K64.1 First degree hemorrhoids Second degree hemorrhoids Treatment - Drugs Treatment - Drugs Intervention group: Ruscus extract 2% ointment/ 2 times daily/ 1 cm of the ointment/ For one month Control group: ointment formolation without any drugs/ 1 cm of the ointment/ For one month Permanent pain. Timepoint: Measuring the amount of pain at the beginning of the study, the first week, the second, third and fourth weeks after the start of the study, is evaluated and recorded. Method of measurement: Visual Analogue Scale. Pain during defecation. Timepoint: Measuring the amount of pain at the beginning of the study, the first week, the second, third and fourth weeks after the start of the study, is evaluated and recorded. Method of measurement: Visual analogue Scale. Anal bleeding. Timepoint: Measuring the amount of bleeding at the beginning of the study, the first week, the second, third and fourth weeks after the start of the study, is evaluated and recorded. Method of measurement: Visually and classified as: bloodless (0), low (1), moderate (2) and high (3). Strain during defecation. Timepoint: Measuring the amount of strain at the beginning of the study, the first week, the second, third and fourth weeks after the start of the study, is evaluated and recorded. Method of measurement: Mental scaling: defecation without strain(0), low(1), intermediate(2), high (3). Burning and itchy and unpleasant. Timepoint: Measuring the amount of Burning and itching at the beginning of the study, the first week, the second, third and fourth weeks after the start of the study, is evaluated and recorded. Method of measurement: Visual analogue Scale. Side effect during treatment. Timepoint: The type of side effect measured during treatment at the first, second, third and fourth week after the start of treatment. Method of measurement: observation and according to questionnaire. Vice chancellor for research and technology, Mazandaran University of Medical Sciences Approved 2018-06-21 Ethics committee of Mazandaran University of Medical moalem sq.vice chancelor of research, MAZUMS Sari Mazandaran Iran (Islamic Republic of)