NCT07072442

Brief Summary

This study aims to investigate if an integrated approach combining Traditional Chinese and Western medicine can better treat knee osteoarthritis. The goal is to see if this combined therapy can more effectively reduce pain severity and frequency, leading to an improved quality of life for KOA patients. Additionally, the study will explore the underlying mechanisms of pain and anti-inflammation related to KOA.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Aug 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Aug 2025Jul 2028

First Submitted

Initial submission to the registry

July 9, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2.9 years

First QC Date

July 9, 2025

Last Update Submit

July 9, 2025

Conditions

Knee Osteoarthristis

Outcome Measures

Primary Outcomes (3)

  • WOMAC

    Western Ontario and McMaster Universities Osteoarthritis (WOMAC) subscale

    From enrollment to 3 months after treatment completion.

  • NRS

    Numerical rating scale (NRS) score for pain

    From enrollment to 3 months after treatment completion.

  • Lequesne's index

    Lequesne's index

    From enrollment to 3 months after treatment completion.

Study Arms (4)

Western medicine

ACTIVE COMPARATOR

Western medicine treatment only

Drug: Western Medicine

Herbal medicine and acupuncture

EXPERIMENTAL

Western medicine combined herbal medicine and acupuncture

Procedure: herbal medicine and acupuncture

herbal medicine

EXPERIMENTAL

Western medicine combined herbal medicine

Drug: herbal medicine

Acupuncture

EXPERIMENTAL

western medicine combined acupuncture

Procedure: acupuncture

Interventions

Western MedicineDRUG

Western medicine treatment only

Western medicine
herbal medicine and acupuncturePROCEDURE

Western medicine combined acupuncture and herbal medicine treatemnt

Herbal medicine and acupuncture
herbal medicineDRUG

Western medicine combined herbal medicine

herbal medicine
acupuncturePROCEDURE

western medicine combined acupuncture

Acupuncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged above 18 years old
  • Kellgren-lawrence grading scale ≥ II
  • Numerical rating scale (NRS) ≥ 4

You may not qualify if:

  • History of bone tumor
  • Pregnancy
  • History of bilateral knee replacement
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

PhytotherapyAcupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 18, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share