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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267432
• Other study ID #: 201703132MSC
• Status: Completed
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: June 12, 2019

Study information

• Verified date: February 2020
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 12, 2019
• Est. primary completion date: June 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Dietary Supplement:
• Placebo
Blank
• TCI633
Probiotics

Drug:
• Type 2 collagen
Positive control group

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KL Grade (evaluated by doctor)	Pain relief and functional improvement in osteoarthritis	Change from baseline at 6 months
Primary	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	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
Secondary	Blood C-reactive protein (CRP) level	To measure the level of CRP in blood	Change from baseline at 6 months