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Clinical Trials/JPRN-jRCTs031200337
JPRN-jRCTs031200337
Completed
Phase 2

An exploratory study of the effects of hot water extract of Salacia spp. on abnormal crypt foci in patients with colonic polyps with abnormal rectal crypt foci: a randomized, double-blind, parallel-group study

Takatsu Tomohiro0 sites0 target enrollmentFebruary 1, 2021

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
colorectal polyp
Sponsor
Takatsu Tomohiro
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Due to the COVID-19 epidemic, we were unable to obtain research funding from corporations, this study was closed before recruitment started.

Registry
who.int
Start Date
February 1, 2021
End Date
November 17, 2021
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Takatsu Tomohiro

Eligibility Criteria

Inclusion Criteria

  • (1\) Patients aged between 20 and 85 years old at the time of enrollment (regardless of gender)
  • (2\) Patients diagnosed with colorectal tumors (adenomas and early stage colorectal cancer) that warrant normal endoscopic resection. (A normal endoscopic resection is a resection after a period of about 8\-12 weeks and is commonly performed in our hospital.)
  • (3\) Patients who are able to undergo endoscopic resection 8 to 12 weeks after the first lower gastrointestinal endoscopy.
  • (4\) Patients with 5 or more ACFs
  • (5\) Patients who are able to visit the hospital
  • (6\) Patients with written consent to participate in this study

Exclusion Criteria

  • (1\) Patients with early\-stage colorectal cancer with lesions bordering on surgery and preferred early treatment
  • (2\) Patients on regular use of NSAIDs, aspirin, etc.
  • (3\) Patients taking anticoagulants or other antiplatelet drugs such as warfarin/NOAC
  • (4\) Patients with diabetes (HbA1c 6\.5% or higher or on diabetes medications)
  • (5\) Patients with serious heart, lung, liver, or kidney problems
  • (6\) Patients with inflammatory bowel disease and familial adenomatosis
  • (7\) Patients who are pregnant, may be pregnant or lactating, or wish to become pregnant during the treatment period
  • (8\) Patients who are contraindicated in the Salacia package insert
  • (9\) Patients who are allergic to salacia
  • (10\) Other patients who are deemed unsuitable for inclusion in the subject matter as determined by the physician.

Outcomes

Primary Outcomes

Not specified

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