Effects of Salacia on ACF

JRCT ID: jRCTs031200337

Registered date:01/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: colorectal polyp
• Date of first enrollment: 01/02/2021
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Arm A: Take placebo tablets orally for 8 weeks, 3 days before meals (Morning: 1 tablet, Day: 1 tablet, Night: 2 tablets)
Arm B: tablets containing hydrothermal extract of Salacia plant orally for 8 weeks, 3 days before meals (Morning: 1 tablet, Day: 1 tablet, Night: 2 tablets)

Outcome(s)

• Primary Outcome: Comparing the change in the number of ACFs between groups
• Secondary Outcome: Ki-67 labeling index, fecal flora, fecal bile acids, blood microarray

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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

Exclude 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.
(11) Patients who regularly take supplements or specific functional foods during the study period.

Related Information

• Primary Sponsor: Takatsu Tomohiro
• Secondary Sponsor: Ashikari Keiichi
• Source(s) of Monetary Support: FUJIFILM