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Completed

NCT Number: NCT04267432

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

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Blank

TCI633

Dietary Supplement

Probiotics

Type 2 collagen

Drug

Positive control group

Primary outcomes

  1. KL Grade (evaluated by doctor)

    Time frame: Change from baseline at 6 months

    Pain relief and functional improvement in osteoarthritis

  2. WOMAC™ Osteoarthritis Index

    Time frame: 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 outcomes

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

    Time frame: Change from baseline at 6 months

    To measure the level of CTX-II in blood

  2. Blood C-reactive protein (CRP) level

    Time frame: Change from baseline at 6 months

    To measure the level of CRP in blood

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2020
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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