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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04267432

Enrollment

102

Registered

2020-02-12

Start date

2018-03-28

Completion date

2019-06-12

Last updated

2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

Blank

DIETARY_SUPPLEMENTTCI633

Probiotics

DRUGType 2 collagen

Positive control group

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
Blood C-reactive protein (CRP) level	Change from baseline at 6 months	To measure the level of CRP in blood

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026