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IRCT2016101830372N1 IRCT 2017-04-15 Vice chancellor for research, Shahid Beheshti University of Medical Sciences Effects of Terminalia Chebula on hemorrhoids Comparing the effects of Terminalia Chebula Retz capsule (A product derived from Iranian traditional medicine) with placebo on the level of bleeding, pain and shirinking of the hemorrhoid pile mass: a randomized double-blind placebo-controlled trial 2017-04-21 anticipated 80 Complete https://irct.ir/trial/24151 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization of this study is based on random numbers table. 3 hemorrhoids. Intervention 1: Intervention group: The intervention group receive one terminalia chebula capsule with empty stomach every 6 hours for four weeks. If the patients did not get any positive response from the capsules, they can use 30 to 60 cc lactulose syrup because constipation is disappeared and one antihemorrhoids suppository daily because pain is disappeared. Intervention 2: Control group: The control group receive one placebo capsule with empty stomach every 6 hours for four weeks. If the patients did not get any positive response from the capsules, they can use 30 to 60 cc lactulose syrup because constipation is disappeared and one antihemorrhoids suppository daily because pain is disappeared.
public Pouran Andarkhor
No.8 Shams Alley, Vali-e-Asr Street
Tehran Iran (Islamic Republic of) +98 21 8877 3521 nama_333@yahoo.com School of Traditional Medicine, Shahid Beheshti University of Medical Sciences scientific Mahmood khodadoost
No.8 Shams Alley, Vali-e-Asr Street
Tehran Iran (Islamic Republic of) +98 21 8877 6327 mkhodadoost@lmo.ir School of Traditional Medicine, Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria include 18 to 65 year-old women and men who have grade I and II hemorrhoids. Exclusion criteria include every severe disease; presence of cancer in every part of the body; every disease in anorectal except hemorrhoids; pregnant and lactating women; patients with history of using anticoagulant, antiplatelet drugs, steroids drugs, drugs with flavonoids (less than a month ago) and pain killers (less than a week ago). 78 years 31 years Both 184.2 internal hemorrhoids without complications Treatment - Drugs Treatment - Drugs Intervention group: The intervention group receive one terminalia chebula capsule with empty stomach every 6 hours for four weeks. If the patients did not get any positive response from the capsules, they can use 30 to 60 cc lactulose syrup because constipation is disappeared and one antihemorrhoids suppository daily because pain is disappeared. Control group: The control group receive one placebo capsule with empty stomach every 6 hours for four weeks. If the patients did not get any positive response from the capsules, they can use 30 to 60 cc lactulose syrup because constipation is disappeared and one antihemorrhoids suppository daily because pain is disappeared. Bleeding of hemorrhoids. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: The number of days (questionnaire). Pain. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: Visual Analog Scale (VAS) (questionnaire). The size of pilel mass. Timepoint: Before the intervention, and at the end of the intervention. Method of measurement: Rectosigmoidoscopy. Constipation. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: ROM III criteria (questionnaire). Exercise. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: At least half an hour daily for 4 days a week (questionnaire). Headache. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: Visual Analog Scale (VAS) (questionnaire). Vertigo. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: Grading of vertigo severity (questionnaire). Diarrhea. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: Mild: <3 loose stools per day, Moderate: 3 to 10 per day, Severe: >10 per day (questionnaire). Dry skin. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: skin dry grading scale (questionnaire). Constipation. Timepoint: Before and after the intervention, at the end of every week, for four weeks. Method of measurement: ROM III criteria (questionnaire). Vice chancellor for research, Shahid Beheshti University of Medical Sciences Approved 2016-10-02 Ethics committee of Shahid Beheshti University of Medical Sciences The Office of Management Research, Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Evin, Shahid Chamran Highway Tehran Iran (Islamic Republic of)