Shengyu Decoction and Lijin Manipulation for Knee OA: 3D Gait Analysis

NCT06451783 | Enrolling By Invitation Early Phase 1 DMC

• 1 other identifier: XuhuiCH202405
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Detailed Description Avoid duplicating information that will be entered or uploaded elsewhere in the record.

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• The western Ontario and McMaster universities osteoarthritis index

  The WOMAC consists of a series of questions that capture the patient's perception of pain, stiffness, and physical function over the past week. It is scored on a numerical scale, with higher scores indicating greater impairment. The index is often used in clinical trials and epidemiological studies to measure changes in osteoarthritis symptoms and to assess the effectiveness of treatments.

  up to 13 weeks

Secondary Outcomes (3)

• Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis

  up to 13 weeks

• Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis

  up to 13 weeks

• Gait Speed in meters per second

  up to 13 weeks

Study Arms (2)

Combined treatment group

EXPERIMENTAL

Traditional Chinese medicine combined with manipulation treatment：the Shengyu Decoction, which consists of the following herbs: * Shu Di Huang 20 grams * Bai Shao 15 grams * Dang Gui 15 grams * Chuan Xiong 8 grams * Ren Shen 20 grams * Huang Qi 18 grams One dose is taken per day, and a course of treatment consists of five weeks.

Other: Traditional Chinese medicine combined with manipulation treatment

Control group

ACTIVE COMPARATOR

Oral control group medication： Oral Celecoxib Capsules, 200mg per dose, once daily after lunch.

Drug: Celecoxib capsule

Interventions

Traditional Chinese medicine combined with manipulation treatment OTHER

The specific procedure involves administering the Shengyu Decoction, which consists of the following herbs: * Shu Di Huang 20 grams * Bai Shao 15 grams * Dang Gui 15 grams * Chuan Xiong 8 grams * Ren Shen 20 grams * Huang Qi 18 grams One dose is taken per day, and a course of treatment consists of five weeks. Add manipulation of massage： * Press and grasp the affected limb three times； * Five-finger five-acupoint pressing method； * Point pressing on Zusanli (ST36) and Sanyinjiao (SP6)； * grasp the interior method to treat the calf three times； ⑤ Apply rolling technique around the knee joint； ⑥ Knead and straighten the standing tendon (the lateral muscle of the calf)； ⑦ Six-finger six-acupoint pressing method； ⑧ Push and pull the patella to flex and extend the knee joint； ⑨ Knee joint reunion and smooth dispersion method.

Combined treatment group

Celecoxib capsule DRUG

Oral Celecoxib Capsules, 200mg per dose, once daily after lunch.

Control group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic criteria of Western medicine: Knee pain for at least 1 month, X-ray showing osteophyte formation, age ≥50 years, morning stiffness ≤30 min, and bone fricative sound.
• TCM diagnostic criteria: Dull pain in the knee joint, flexion and extension limitations, pitching and side rotation unfavorability, slight activities slightly relieve pain, climate change aggravates symptoms, and repeated middle-aged and elderly patients, hidden onset, slow onset, slight local swelling of the knee joint, friction or clicking sound when moving, and severe cases may show muscle atrophy and joint deformity.
• Radiographs showing joint space narrowing, bone hyperplasia, subchondral osteosclerosis, and osteophyte formation.
• Patients who are between 45 and 85 years old.
• Patients who can understand and provide informed consent.
• Patients who are willing and able to undergo manual treatment for 1 course of treatment and cooperate with the doctor to complete the study.

You may not qualify if:

• Patients who do not meet the diagnostic criteria for knee osteoarthritis established by the rheumatology society.
• Severe knee pain with surgical indications (or X-ray grading standards reached level 4).
• Pregnant or planning to become pregnant.
• Patients who have participated in or are participating in other clinical trials within the last 3 months.
• Patients who have received or are receiving other treatment methods such as drugs that affect the evaluation of efficacy within the past 3 months.
• Patients with fractures, dislocation, skin damage, and severe infectious skin diseases within three weeks.
• Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system, cardiovascular and cerebrovascular, nervous system, tuberculosis, joint malformations, tumors, and psychiatric patients and postoperative patients.
• Patients who are unable to accurately evaluate the effectiveness and safety of treatment due to their medical condition.

Sponsors & Collaborators

• Xuhui Central Hospital, Shanghai: lead

Study Sites (1)

Qiao Liang

Shanghai, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Combined treatment group：Traditional Chinese medicine combined with manipulation treatment Control group：Oral control group medication

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: June 11, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)