The external treatment of traditional Chinese medicine for knee osteoarthritis: study protocol for a randomized controlled trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000038499

Enrollment

Unknown

Registered

2020-09-23

Start date

2020-10-01

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Knee osteoarthritis

Interventions

treatment group:integrated program of external treatment of traditional Chinese medicine (Chinese herbs by iontophoresis and Babu plaster application on acupoints)

control group:standardized package of Western medicine external treatment (dichofenac Diethylammon by iontophoresis and ketoprofen application)

Eligibility

Sex/Gender

All

Age

45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Match the diagnostic criteria and TCM syndrome differentiation standard of knee osteoarthritis; 2. The pain above moderate (VAS>=4); 3. Aged between 40 and 75 years old; 4. Before entering the study, without taking any therapeutic drugs at least 1 month and participating in other clinical study; 5. Signing an informed consent in writing by the patient or the immediate family member.

Exclusion criteria

Exclusion criteria: 1. Allergic constitution; 2. Skin breakage on knee; 3. Complicating with severe cardiovascular, hepar, nephros, digestive, hematopoietic system diseases; 4. Impregnate or lactation female; 5. Patients with advanced cancer or other serious wasting diseases, easy to be infected and bleeding.

Design outcomes

Primary

Measure	Time frame
WesternOntario McMasterUniversities (WOMAC) Osteoarthritis Index Bellamy;	—

Secondary

Measure	Time frame
Quality of life scale for arthritis;	—

Countries

China

Contacts

Public ContactNan Wu

Henan University of Chinese Medicine

wunanwy@126.com+86 13540484550

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026