Evaluation of the effects of Tu Dieu Thang prescription combined with electroacupuncture and shortwave therapy on patients with knee osteoarthritis

A clinical trial evaluating the efficacy and safety of Tu Dieu Thang prescription combined with electroacupuncture and shortwave therapy in the treatment of knee osteoarthritis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20251031003

Enrollment

Registered

2025-10-31

Start date

2023-04-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis Osteoarthritis of the knee Degenerative joint disease Joint pain Mobility limitation Tu Dieu Thang Herbal medicine Traditional medicine Electroacupuncture Shortwave therapy Integrative medicine Pain management Knee joint WOMAC score VAS pain scale

Interventions

Participants in the experimental group receive the Tu Dieu Thang herbal decoction together with electroacupuncture and shortwave therapy for 21 consecutive days. Tu Dieu Thang: daily dose of 1 decoct

Experimental Drug,Experimental Procedure/Surgery

Tu Dieu Thang combined with electroacupuncture and shortwave therapy,Electroacupuncture and shortwave therapy only

Eligibility

Sex/Gender

All

Age

38 Years to 75 Years

Inclusion criteria

Inclusion criteria: Adults aged 38 years or older diagnosed with primary knee osteoarthritis according to the American College of Rheumatology (1991) criteria. Radiographic grade I and II based on the Kellgren Lawrence classification. Visual Analogue Scale (VAS) pain score smaller than 6. Traditional medicine diagnosis of rheumatic fever with kidney deficiency.

Exclusion criteria

Exclusion criteria: Secondary knee osteoarthritis due to rheumatoid arthritis, gout, trauma, metabolic or endocrine disorders. Severe comorbidities (heart, liver, or kidney failure; malignancy; psychiatric illness). Contraindications to acupuncture or shortwave therapy. Use of NSAIDs within 10 days or corticosteroid injections within 3 months before enrollment. Pregnancy or breastfeeding.

Design outcomes

Primary

Measure	Time frame
Change in pain intensity measured by the Visual Analogue Scale (VAS) Baseline Day 0 and Day 21 Difference in 10 cm VAS pain score from baseline to Day 21,Change in functional status measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Baseline (Day 0) and Day 21 Total WOMAC score assessed by patient questionnaire including pain, stiffness, and physical function; lower scores indicate better function.	—

Measure

Time frame

Change in pain intensity measured by the Visual Analogue Scale (VAS) Baseline Day 0 and Day 21 Difference in 10 cm VAS pain score from baseline to Day 21,Change in functional status measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Baseline (Day 0) and Day 21 Total WOMAC score assessed by patient questionnaire including pain, stiffness, and physical function; lower scores indicate better function.

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Secondary

Measure	Time frame
Improvement in knee joint range of motion (ROM) Baseline Day 0 and Day 21 Knee flexion angle measured in degrees using a goniometer; increased angle indicates improved joint mobility.,Change in stiffness subscore of WOMAC Baseline Day 0 and Day 21 WOMAC stiffness subscore assessed by patient questionnaire; lower score indicates reduced joint stiffness.,Change in laboratory safety parameters (ALT, AST, creatinine, hemoglobin, platelets) Baseline (Day 0) and Day 21 Serum ALT, AST, creatinine, hemoglobin, and platelet levels measured by standard automated laboratory assays.,Incidence of adverse events (bleeding, infection, shock, etc.) Continuous monitoring during 21-day treatment Number and type of adverse events recorded by clinician observation and patient report during treatment.	—

Measure

Time frame

Improvement in knee joint range of motion (ROM) Baseline Day 0 and Day 21 Knee flexion angle measured in degrees using a goniometer; increased angle indicates improved joint mobility.,Change in stiffness subscore of WOMAC Baseline Day 0 and Day 21 WOMAC stiffness subscore assessed by patient questionnaire; lower score indicates reduced joint stiffness.,Change in laboratory safety parameters (ALT, AST, creatinine, hemoglobin, platelets) Baseline (Day 0) and Day 21 Serum ALT, AST, creatinine, hemoglobin, and platelet levels measured by standard automated laboratory assays.,Incidence of adverse events (bleeding, infection, shock, etc.) Continuous monitoring during 21-day treatment Number and type of adverse events recorded by clinician observation and patient report during treatment.

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Countries

Vietnam

Contacts

Public ContactAnh Tuan Tran

Faculty of Traditional Medicine, Phenikaa School of Medicine and Pharmacy, Phenikaa University

tuan.trananh1@phenikaa-uni.edu.vn842462918118

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026