Back to resultsThe Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo
TCI633
Type 2 collagen
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion criteria
- Osteoarthritis patients with joint pain or discomfort (diagnosed by the physician for severe classification of the Kellgren-Lawrence Grade 1-3)
- Without heart, liver, kidney, endocrine and other major organic diseases (patient return)
Exclusion criteria
- 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)
- People with mental illness
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Active Comparator
Arm Label
Placebo
TCI633
Type 2 collagen
Arm Description
Placebo
Testing product
Known drug for OA
Outcomes
Primary Outcome Measures
KL Grade (evaluated by doctor)
Pain relief and functional improvement in osteoarthritis
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.
Secondary Outcome Measures
Blood C-terminal telopeptide of collagen type II (CTX-II) level
To measure the level of CTX-II in blood
Blood C-reactive protein (CRP) level
To measure the level of CRP in blood
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04267432
Brief Title
The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis
Official Title
The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
June 12, 2019 (Actual)
Study Completion Date
June 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
TCI633
Arm Type
Experimental
Arm Description
Testing product
Arm Title
Type 2 collagen
Arm Type
Active Comparator
Arm Description
Known drug for OA
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Blank
Intervention Type
Dietary Supplement
Intervention Name(s)
TCI633
Intervention Description
Probiotics
Intervention Type
Drug
Intervention Name(s)
Type 2 collagen
Intervention Description
Positive control group
Primary Outcome Measure Information:
Title
KL Grade (evaluated by doctor)
Description
Pain relief and functional improvement in osteoarthritis
Time Frame
Change from baseline at 6 months
Title
WOMAC™ Osteoarthritis Index
Description
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 Outcome Measure Information:
Title
Blood C-terminal telopeptide of collagen type II (CTX-II) level
Description
To measure the level of CTX-II in blood
Time Frame
Change from baseline at 6 months
Title
Blood C-reactive protein (CRP) level
Description
To measure the level of CRP in blood
Time Frame
Change from baseline at 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Osteoarthritis patients with joint pain or discomfort (diagnosed by the physician for severe classification of the Kellgren-Lawrence Grade 1-3)
Without heart, liver, kidney, endocrine and other major organic diseases (patient return)
Exclusion criteria
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)
People with mental illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting-Ming Wang, Doctor
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis
We'll reach out to this number within 24 hrs