Clinical efficiency and safety of Thai herbal recipe in patients with osteoarthritis of knee

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15007213

Enrollment

Unknown

Registered

2015-10-14

Start date

2015-11-02

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Osteoarthritis

Interventions

1:Thai herbal recipe

2:Diclofenac

Eligibility

Sex/Gender

All

Age

45 Years to No maximum

Inclusion criteria

Inclusion criteria: Out-patients of either sex, aged over >=45 years, suffering from unilateral or bilateral knee OA according to the criteria of ACR as: knee pain and radiographic osteophytes, and at least 1 of the following 3 items: aged over 50 years, morning stiffness not more than 30 min in duration, or crepitus on motion. The symptoms must be present at least 3 months. After stopped using usual analgesic drugs or NSAIDs for 7 days, VAS of knee pain must be >=35 out of 100. All of participants must be able to walk. All patients will be informed both verbally and in writing of the possible risk and adverse events which may occur during the study and sign the written consent forms to participate in the study.

Exclusion criteria

Exclusion criteria: Participants will be excluded if they have the following diseases or conditions: underlying inflammatory arthropathy such as RA and gout, hyperuricemia (uric acid > 9 mg/dL), expectation of surgery in the near future, recent injury in the area affected by OA of knee, active inflammation of OA of knee, intra-articular corticosteroid injection within the last 6 weeks, history of gastrointestinal (GI) ulcer, GI perforation and GI hemorrhage, hypersensitivity to NSAIDs and drugs or herbs used in this study, acute OA attack (inflammation, edema, redness, warm), significant knee joint effusion, continuous use of symptomatic slow-acting drugs for OA (SYSDOA) [e.g., glucosamine sulphate, chondroitin sulphate, diacerein, and hyaluronan] less than 4 months or stop using these drugs less than 6 months, pregnancy, lactation, malignant tumors, and clinically significant abnormalities in blood chemistry and hematology.

Design outcomes

Primary

Measure	Time frame
Number of responders according to pain reduction;	—

Secondary

Measure	Time frame
Visual analog scale (VAS) score of pain and stiffness;Knee injury and Osteoarthritis Outcome Score (KOOS);Patients' overall opinions on improvement;	—

Countries

Thailand

Contacts

Public ContactAssoc. Prof. Dr. Supanimit Teekachunhatean

supanimit.t@cmu.ac.th+66 (0) 53935353

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026