NCT04267432

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

January 6, 2020

Last Update Submit

February 10, 2020

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Blood C-terminal telopeptide of collagen type II (CTX-II) level

    Change from baseline at 6 months

  • Blood C-reactive protein (CRP) level

    Change from baseline at 6 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

TCI633

EXPERIMENTAL

Testing product

Dietary Supplement: TCI633

Type 2 collagen

ACTIVE COMPARATOR

Known drug for OA

Drug: Type 2 collagen

Interventions

PlaceboDIETARY_SUPPLEMENT

Blank

Placebo
TCI633DIETARY_SUPPLEMENT

Probiotics

TCI633
Type 2 collagenDRUG

Positive control group

Type 2 collagen

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ting-Ming Wang, Doctor

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2020

First Posted

February 12, 2020

Study Start

March 28, 2018

Primary Completion

June 12, 2019

Study Completion

June 12, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

TW(1)