NCT04110847

Brief Summary

To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients with knee or hip osteoarthritis (OA).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2010

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 22, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2012

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

September 30, 2019

Last Update Submit

September 30, 2019

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Universities (WOMAC)

    The investigators use WOMAC to compared the difference between the week 12 and week 0

    week 0, week 12

Secondary Outcomes (8)

  • serum osteocalcin level

    week 0, week 12

  • serum C-terminal telopeptide (CTX) level

    week 0, week 12

  • Western Ontario and McMaster Universities (WOMAC)

    week 0, week 4, week 8

  • Visual Analog Scale for pain (VAS)

    week 0, week 4, week 8, week 12

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

    week 0, week 4, week 8, week 12

  • +3 more secondary outcomes

Study Arms (2)

TCM OA1

ACTIVE COMPARATOR

JING CEIH SHERN YUAN EXTRACT PILL "CHUANG SONG ZONG" 3 TABLET For 2 Times per day

Drug: JING CEIH SHERN YUAN EXTRACT PILL

Placebo

PLACEBO COMPARATOR

Placebo 3 TABLET For 2 Times per day

Drug: JING CEIH SHERN YUAN EXTRACT PILL

Interventions

JING CEIH SHERN YUAN EXTRACT PILLDRUG

Oral use, 3#BID

PlaceboTCM OA1

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age ≥20 years old 2. Written informed consent obtained 3. Been diagnosed with knee or hip osteoarthritis 4. The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed 5. In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week 6. 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. 2. Chemotherapy or radiation therapy in cancer patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Cheng Ching Wei, Ph. 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 30, 2019

First Posted

October 1, 2019

Study Start

March 22, 2010

Primary Completion

December 5, 2011

Study Completion

January 10, 2012

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share