The clinical research of Pien Tze Huang capsule in the treatment for patients with unilateral primary total knee replacement

A placebo, single-center, randomized double-blind parallel design trial for evaluation of the safety and efficacy of Pien Tze Huang capsule in treatment for patients with wound inflammation after unilateral primary total knee replacement

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800019257

Enrollment

Unknown

Registered

2018-11-01

Start date

2018-12-01

Completion date

Unknown

Last updated

2018-11-05

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

Conditions

wound inflammation after total knee replacement

Interventions

Group 1:PIEN TZE HUANG Capsule + basic treatment

Group 2:placebo+basic treatment

Eligibility

Sex/Gender

All

Age

50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 50 to 70 years old; 2. Patients with knee Osteoarthritis; 3. Patients with unilateral primary total knee replacement; 4. Colour duplex ultrasonography showed DVT was negative before unilateral primary total knee replacement; 5. Patients who sign the informed consent form freely and voluntarily.

Exclusion criteria

Exclusion criteria: 1. Colour duplex ultrasonography showed DVT was positive before unilateral primary total knee replacement,or patients with deep venous valvular insufficiency of lower extremities; 2. Patients with previous DVT; 3. Combined with rheumatoid arthritis,ankylosing spondylitis,Kaschin-Beck disease,valgus knee deformity,hemophilic arthritism,or other infectional arthritis. 4. Diabetic Patients; 5. ALB<30g/L; 6. CRP exceeding 1.5 times than normal limit; 7. The liver function (ALT,AST) exceeding 1.5 times than normal limit, the kidney function (Cr) exceeding the normal limit, or those who suffer from impaired immunity disease; 8. Combined with bone tumour or other serious disease; 9. Allergic constitution patients,who are allergic to the drugs which used in this research; 10. Participating in other clinical trial, or participated in any other clinical treatment within 3 months prior to screening; 11. Lactating or pregnant women,planning for pregnancy; 12. The researchers consider the patients are not suitable; 13. Poor compliance,or patients can not understand the situation of this study and do not sign the informed consent form.

Design outcomes

Primary

Measure	Time frame
CRP (2 weeks after TKR);	—

Secondary

Measure	Time frame
CRP after TKR;pain scores during movement (VAS);pain scores at rest (VAS);Thigh circumference;Calf Circumference;Differential knee skin temperature;HSS score, knee ROM;the use of painkillers;healing rates of wounds;postoperative drainage;TNF-a, IL-6, E2, BK, a - defensin, HMGB1, HCY;	—

Countries

China

Contacts

Public ContactHe Wei

First Affiliated Hospital of Guang zhou University of Chinese Medicine

hw13802516062@126.com+86 13802516062

Outcome results

None listed

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