The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis

TCI Co., Ltd.102 enrolled

Overview

To assess TCI633 probiotics on pain relief and functional improvement in osteoarthritis

This is a double-blind and randomized study. Subjects are informed to consume the samples before meals in the morning every day. The clinical and radiological diagnosis of osteoarthritis of the knee is evaluated by the doctor. The blood samples and questionnaires are collected at every visit of the trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

102

Conditions

Osteoarthritis

Interventions

PlaceboDIETARY_SUPPLEMENT

Blank

TCI633DIETARY_SUPPLEMENT

Probiotics

Type 2 collagenDRUG

Positive control group

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion criteria 1. Osteoarthritis patients with joint pain or discomfort (diagnosed by the physician for severe classification of the Kellgren-Lawrence Grade 1-3) 2. Without heart, liver, kidney, endocrine and other major organic diseases (patient return) Exclusion criteria 1. With heart, liver (GOT and GPT values are 3-fold higher than the standard maximum), kidney (estimated creatinine clearance less than 25 mL/min), endocrine and other major organic diseases (patient return) 2. People with mental illness

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

KL Grade (evaluated by doctor)

Pain relief and functional improvement in osteoarthritis

Time frame: Change from baseline at 6 months

WOMAC™ Osteoarthritis Index

The questionnaire includes three-part: i) join pain (five questions); ii) joint stiffness (two questions); and, iii) physical functions of joints (seventeen questions). Each question is scored 0-4. Low to high WOMAC scores represent slight to severe OA symptoms. The lower scores mean a better outcome.

Time frame: Change from baseline at 6 months

Secondary Outcomes

Blood C-terminal telopeptide of collagen type II (CTX-II) level

To measure the level of CTX-II in blood

Time frame: Change from baseline at 6 months

Blood C-reactive protein (CRP) level

To measure the level of CRP in blood

Time frame: Change from baseline at 6 months

Data from ClinicalTrials.gov

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