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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: TCI633; Drug: Type 2 collagen

• Registration Number: NCT04267432
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2018-03-28
• Primary Completion: 2019-06-12
• Study Completion: 2019-06-12
• Study First Submitted: 2020-01-06
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-12
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
TCI633	TCI633	Testing product
Type 2 collagen	Type 2 collagen	Known drug for OA

Primary Outcome Measures

Name	Time	Method
WOMAC™ Osteoarthritis Index	Change from baseline at 6 months	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.
KL Grade (evaluated by doctor)	Change from baseline at 6 months	Pain relief and functional improvement in osteoarthritis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan