Precision Application of Clostridium Butyricm of Clinical Research on Osteoarthritis
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
North District
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Taichung, North District, Taiwan, 404327
- China Medical University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A. Patients aged 55 to 75 years old with degenerative arthritis, diagnosed by a physician as suitable for participation in this experiment.
B. Patients with early-stage degenerative arthritis symptoms, as interpreted by X-ray using the Kellgren Lawrence Grading Scale at grade 1 or 2, and determined by a physician to not require long-term treatment.
C. Patients with a high pain index when the knee is extended 40-70 mm.
D. Patients who feel knee pain, primarily those with a high Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index score (pain scale score >2.0 or total WOMAC scale score >12).
Exclusion Criteria:
- A. Patients with a history of knee joint trauma or knee joint surgery (including arthroscopic surgery).
B. Patients who have taken steroid medication for the treatment of degenerative arthritis.
C. Patients with severe cardiovascular, cerebrovascular, rheumatic, or psychiatric diseases.
D. Patients with joint pain caused by other factors.
E. Patients with infectious diseases or acute infections (e.g., fever, localized inflammation, abscess).
F. Patients with systemic or metabolic diseases, or progressive bone degeneration caused by medication.
G. Cancer patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Group A (placebo)
|
1. WOMAC is widely used in the evaluation of Hip and Knee Osteoarthritis.
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales
2. VAS is one of the pain rating scales used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
3. KL score is the most widely used clinical tool for the radiographic diagnosis of OA.Each radiograph was assigned a grade from 0 to 4,
4. Quality of Life Questionnaires and Assessments: include quality of life, intestinal tract, conscious assessment of pain relief.etc.
|
|
Experimental: Group B (Treatment)
|
1. WOMAC is widely used in the evaluation of Hip and Knee Osteoarthritis.
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales
2. VAS is one of the pain rating scales used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
3. KL score is the most widely used clinical tool for the radiographic diagnosis of OA.Each radiograph was assigned a grade from 0 to 4,
4. Quality of Life Questionnaires and Assessments: include quality of life, intestinal tract, conscious assessment of pain relief.etc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Time Frame: Day 0, 7, 14, 30, 60, 90
|
used in the evaluation of Hip and Knee Osteoarthritis.
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales.
The maxima score is 105, which have more high score mean more severe level of osteoarthritis.
|
Day 0, 7, 14, 30, 60, 90
|
|
Visual Analogue Scale (VAS)
Time Frame: Day 0, 7, 14, 30, 60, 90
|
one of the pain rating scales used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
The minima score is 0. The maxima score is 10 for each knee.
the higher score mean patient feel more pain on knee joint.
|
Day 0, 7, 14, 30, 60, 90
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH112-REC3-047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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