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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-28

Study Completion Date

2019-06-12

Brief Summary

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

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Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Blank

TCI633

Testing product

Group Type EXPERIMENTAL

TCI633

Intervention Type DIETARY_SUPPLEMENT

Probiotics

Type 2 collagen

Known drug for OA

Group Type ACTIVE_COMPARATOR

Type 2 collagen

Intervention Type DRUG

Positive control group

Interventions

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Placebo

Blank

Intervention Type DIETARY_SUPPLEMENT

TCI633

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Type 2 collagen

Positive control group

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No