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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016101830372N1

Enrollment

Registered

2017-04-15

Start date

2017-04-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemorrhoids. internal hemorrhoids without complications

Interventions

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 fro

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,

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

Eligibility

Sex/Gender

All

Age

78 Years to 31 Years

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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: 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).	—

Measure

Time frame

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: 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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactPouran Andarkhor

School of Traditional Medicine, Shahid Beheshti University of Medical Sciences

nama_333@yahoo.com+98 21 8877 3521

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026