Randomized, double-blind, placebo-controlled clinical trial of Jingu Zhitong Ningjiao in treatment of knee osteoarthritis with kidney deficiency and blood stasis

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2024000175

Enrollment

Unknown

Registered

2024-08-06

Start date

2023-11-01

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

knee osteoarthritis

Interventions

Jingu Zhitong Ningjiao treatment group:Apply knee joint topical muscle and bone analgesic gel [batch No. : Z20200003, Jiangsu Kangyuan Pharmaceutical Co., LTD.] on knee joint pain, treat 2 times a day

Jingu Zhitong Ningjiao treatment group:The pain of the knee joint was smeated with external muscle and bone analgesic gel simulator, treated twice a day, 3g each time, for 8 weeks,work with the quadri

Eligibility

Sex/Gender

All

Age

40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1) Meeting the diagnostic criteria of KOA (refer to the 2018 edition of Osteoarthritis Diagnosis and Treatment Guidelines); 2) Kellgren LawrenceX classification was grade I to ?. 3) It meets the diagnostic criteria of TCM KOA with kidney deficiency and blood stasis (according to the 2018 edition of "Guiding Principles for Clinical Research of New Chinese Medicine" and 2018 edition of "TCM Clinical Diagnosis and Treatment Terms · Syndrome Part"); 4) Age 40-75 years old, gender is not limited; 5) Patients who voluntarily receive treatment and sign informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1) Patients complicated with knee joint tuberculosis, knee joint tumor, acute knee joint injury and other diseases; 2) Advanced KOA patients, knee space is obviously narrow or rigid; 3) Pregnant and lactating women; 4) Suffering from serious heart, lung, brain and blood system diseases; 5) Patients currently participating in other clinical trials.

Design outcomes

Primary

Measure	Time frame
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index;	—

Secondary

Measure	Time frame
Knee range of motion;Cartilage thickness;visual analogue scale,VAS;Temperature difference before and after knee joint treatment;TCM syndrome integral;	—

Countries

China

Contacts

Public ContactLiu Aifeng

The First Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin, China

draifeng@163.com+86 138 0309 1533

Outcome results

None listed

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