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Completed

NCT Number: NCT04492670

Tui-na and Oral Chinese Medicine on KOA

The study aims to evaluate the therapeutic effect of the Tui-na and oral Chinese medicine on the treatment of KOA.

This is a prospective, randomized wait-list controlled trial in patients with knee osteoarthritis (KOA). After 2 weeks screening period, eligible subjects will be randomly assigned to the treatment group and wait-list control group in 1:1 ratio. Subjects will have 4-week of treatment, and then a 4-week follow-up.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong

About this study

The subjects will come for a screening visit at week 0 (baseline), then at week 2, week 4, and week 8 for Chinese medicine practitioner (CMP) investigators assessments. The Western Ontario and McMaster University Osteoarthritis index (WOMAC) and EQ-5D-5L will be assessed and filled up at different timepoints. The treatment group will receive both Tui-na and study medication and the wait-list control group will receive Tui-na alone. CMPs will provide consultation under Chinese medicine theory. Study medication compliance and adverse events will also be assessed at each visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • of either gender (female must have either sterilization done or menopause)
  • ≥50years of age
  • meet the criteria of KOA according to the American College of Rheumatology
  • Knee pain, and
  • Any 4 of the following,
  • ≥ 50 years of age
  • Less than 30 minutes of morning stiffness
  • Crepitus on active motion
  • Bony tenderness
  • Bony enlargement
  • No palpable warmth of synovium
  • Osteophytes (Radiographic findings)
  • with WOMAC score ≥ 39
  • with written informed consentform signed (for illiterate subjects, their next-of-kin or an impartial witness will sign with subjects' permission)

Exclusion criteria

  • Known knee pain caused by infection, malignant or autoimmune diseases
  • Knee surgery or arthroscopy in the past year
  • Chondroprotective or intra-articular injection in the past 4 months
  • Systemic corticoid treatment in the past 4 months
  • Taking anticoagulants, antiplatelets, corticosteroids, psychiatric drugs, hormones, antiarrhythmic drugs or diuretics drugs
  • Subject with uncontrolled hypertension
  • Local antiphlogistic treatment, acupuncture, physiotherapy in the past 2 weeks
  • Known history of mental disorder
  • Known history of serious acute organic disease
  • Renal or liver function impairment
  • Known allergy to or have drug interaction with the study herb

Treatment and study plan

Tui-na

Procedure

For administering of Tui-na manipulation practice, responsible Tui-na CMP must have at least 2 years of clinical experience. The pre-trial workshops led by a senior practitioner will be organized to ensure standardization of Tui-na treatment manipulation and procedures.

Du-Huo-Ji-Sheng-Tang (DHJST)

Drug

This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used.

Other names: Herbal granules

Primary outcomes

  1. The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: 4 weeks

    to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96

Secondary outcomes

  1. EQ-5D-EL questionnaire

    Time frame: 8 weeks

    to assess health-related quality of life, one part is descriptive has 5 response level, the other part is VAS which ranges from 0 to 100

  2. The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: at 2 weeks and 8 weeks

    to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

The Therapeutic Effect of a Combined Therapy of Tui-na and Oral Chinese Medicine on Osteoarthritis of Knee - A Randomized Wait-list Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2020
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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