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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: TCI633; Drug: Type 2 collagen

Detailed Description

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
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Blank
Experimental: TCI633; Testing product	Dietary supplement: TCI633; Probiotics
Active Comparator: Type 2 collagen; Known drug for OA	Drug: Type 2 collagen; Positive control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KL Grade (evaluated by doctor)	Pain relief and functional improvement in osteoarthritis	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.	Change from baseline at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood C-terminal telopeptide of collagen type II (CTX-II) level	To measure the level of CTX-II in blood	Change from baseline at 6 months
Blood C-reactive protein (CRP) level	To measure the level of CRP in blood	Change from baseline at 6 months

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Ting-Ming Wang, Doctor, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): June 12, 2019
• Study Completion (Actual): June 12, 2019

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 201703132MSC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No