Evaluation of Sodium Pentaborate on Left Side Ulcerative Colitis

Evaluation of Sodium Pentaborate Enema on Left Side Ulcerative Colitis Clinical Signs and Colonoscopic Findings

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190701044062N11

Enrollment

Registered

2022-09-08

Start date

2022-08-23

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Ulcerative Colitis. Ulcerative colitis

Interventions

Intervention 1: Intervention group: Patients in the intervention group are prescribed 2 grams of Oral tablet of mesalazine daily and a Sodium Pentaborate 3% rectal enema gel(Satin Tan Kimia company pr

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: All left side ulcerative colitis patients who are between 18 and 65 years old

Exclusion criteria

Exclusion criteria: Patients who can't endure enema Patients with other diseases as : Crohn's disease, Intermediate Colitis, CMV, Pseudomemberanous Colitis, Heart Failure, CRF, PSC Pregnant or breastfeeding patients

Design outcomes

Primary

Measure	Time frame
Activity of disease based on Mayo score. Timepoint: Assessment of disease activity at the beginning of the study and 28 days after the start of using Sodium Pentaborate enema. Method of measurement: Mayo Score.	—

Secondary

Measure	Time frame
Frequency of daily defecation. Timepoint: Assessment of daily defecation frequency at the beginning of the study and 28 days after the start of using Sodium Pentaborate enema. Method of measurement: By asking the patient about frequency of daily defecation and using it in Mayo Score scale.;Rectal Bleeding. Timepoint: Assessment of rectal bleeding at the beginning of the study and 28 days after the start of using Sodium Pentaborate enema. Method of measurement: By asking the patient about frequency and amount of of rectal bleeding and using it in Mayo Score scale.;Endoscopic findings. Timepoint: Assessment of endoscopic findings at the beginning of the study and 28 days after the start of using Sodium Pentaborate enema. Method of measurement: By direct vision of endoscopist based on Endoscopic Sub Score in Mayo Score scale.	—

Measure

Time frame

Frequency of daily defecation. Timepoint: Assessment of daily defecation frequency at the beginning of the study and 28 days after the start of using Sodium Pentaborate enema. Method of measurement: By asking the patient about frequency of daily defecation and using it in Mayo Score scale.;Rectal Bleeding. Timepoint: Assessment of rectal bleeding at the beginning of the study and 28 days after the start of using Sodium Pentaborate enema. Method of measurement: By asking the patient about frequency and amount of of rectal bleeding and using it in Mayo Score scale.;Endoscopic findings. Timepoint: Assessment of endoscopic findings at the beginning of the study and 28 days after the start of using Sodium Pentaborate enema. Method of measurement: By direct vision of endoscopist based on Endoscopic Sub Score in Mayo Score scale.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactManouchehr Khoshbaten

Tabriz University of Medical Sciences

mkhoshbaten@yahoo.com+98 41 3337 2088

Outcome results

None listed

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