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Efficacy and safety of Quanduzhong Jiaonang in treatment of knee osteoarthritis with hypertension(deficiency of liver and kidney type):a multicenter, randomized, double-blind, parallel controlled clinical trial

Efficacy and safety of Quanduzhong Jiaonang in treatment of knee osteoarthritis with hypertension(deficiency of liver and kidney type):a multicenter, randomized, double-blind, parallel controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075332
Enrollment
Unknown
Registered
2023-09-01
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

knee osteoarthritis/hypertension

Interventions

Experimental group:Oral administration of Quanduzhong Jiaonang and the simulator of Tenghuangjiangu Pian
Control group:Oral administration of Tenghuangjiangu Pian and the simulator of Quanduzhong Jiaonang

Sponsors

The Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)Conform to the western medicine diagnosis of knee osteoarthritis and KL stage I-?; (2)It is consistent with the clinical stage of remission of knee osteoarthritis; (3)It met the diagnostic criteria for essential hypertension in the 2018 Chinese guidelines for the management of hypertension, and the cardiovascular risk level was classified as low and medium risk; (4)The patient took western antihypertensive drugs for more than 4 weeks, and the blood pressure was controlled between 130/80mmHg (inclusive) and 159/99mmHg (inclusive); (5)Aged 40-80 years; (6)Conform to the traditional Chinese medicine diagnosis of deficiency of liver and kidney type.

Exclusion criteria

Exclusion criteria: (1) Known or suspected secondary hypertension; (2) serious heart, brain and hematopoietic system diseases; (3) Liver and kidney dysfunction, ALT, AST more than 2 times the upper limit of normal, Cr more than the upper limit of normal, BUN more than the upper limit of normal; (4) endocrine diseases such as Cushing's syndrome; (5) Malignant tumors; (6) Pain caused by other orthopedic diseases; (7) Patients who have undergone surgical procedures or invasive treatments within four weeks. (8) A history of gastrointestinal surgery that has the potential to significantly alter drug absorption, distribution, metabolism, and excretion (e.g., gastrectomy, gastrostomy, or enterectomy, gastric bypass, gastrointestinal banding, etc.); (9) a history of mental illness, or a suspected or confirmed history of drug abuse; (10) are currently participating in other clinical studies or have participated in other clinical investigators within 3 months; (11) People who are known to have a history of allergy to drugs with similar composition and chemical structure of the study drug, control drug or analog drug; (12) staff members directly involved in the research; (13) Pregnant and lactating women who have family planning during the medication period and within 3 months after the end of the last medication.

Design outcomes

Primary

MeasureTime frame
visual analogue scale score;

Secondary

MeasureTime frame
TCM syndrome classification score;Western Ontario and McMaster University Osteoarthritis Index score;SF-12 score;Average blood pressure drop;Effective rate of blood pressure lowering;

Countries

China

Contacts

Public ContactChen Weiheng

The Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine

drchenweiheng@163.com+86 135 1101 3261

Outcome results

None listed

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