Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis.

NCT04108832 | Completed Phase 2 DMC

• 1 other identifier: CS13048
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Through an eight-week randomized, double-blind, placebo-controlled clinical trials formula to evaluate Chinese herbal compound OA2 improve osteoarthritis of efficacy and safety.

Conditions

Osteoarthritis

Keywords

Traditional Chinese Medicine; Herbs; Liu-wei-die-Huang-Wan

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities (WOMAC)

  The investigators use WOMAC to compared the difference between the week 8 and week 0

  week 0, week 4, week 8

Secondary Outcomes (5)

• Visual Analog Scale for pain (VAS)

  week0, week 4 and 8

• Physicians Global Assessment to measure quality of life (PGA)

  week0, week 4 and week 8

• Quality of life by SF-36

  week0, week 2 and week 4

• High sensitivity C-reactive protein (Hs-CRP)

  week0, week 8

• Erythrocyte sedimentation rate (ESR)

  week0, week 8

Study Arms (2)

TCM OA2

EXPERIMENTAL

TCM OA2 3G BID FOR 8 WEEKS

Drug: TCM OA2

PLACEBO

PLACEBO COMPARATOR

PLACEBO

Drug: PLACEBO

Interventions

TCM OA2 DRUG

Usage: 3g twice daily

Also known as: LIOW WEY DIH HUANG WAN EXTRACT PILL

TCM OA2

PLACEBO DRUG

Usage: 3g twice daily

PLACEBO

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥20 years old
• Written informed consent obtained
• Been diagnosed with knee or hip osteoarthritis
• The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed
• In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week
• The WOMAC osteoarthritis index of the degree of pain assessment in the past two weeks at least\> 4ppm pain

You may not qualify if:

• Pregnant or breast-feeding women.
• Chemotherapy or radiation therapy in cancer patients

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Wei C- C, M.D.

  Chung Shan Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 30, 2019
• Study Start: January 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)