Efficacy and Safety of Benjakul Remedy Extract Capsule in Primary Osteoarthritis versus Naproxen (Clinical Trial Phase III)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20200827001

Enrollment

350

Registered

2020-08-27

Start date

2020-08-26

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Patients with knee osteoarthritis

Interventions

oral Naproxen 250 mg,oral Benjakul Remedy Extract Capsule 100 mg

Active Comparator Drug,Experimental Drug

Naproxen,Benjakul

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of idiopathic OA knee according to clinical criteria of American College of Rheumatology Knee pain + at least 3 of 6: o Age > 50 years o morning stiffness< 30 minutes o crepitus o bony tenderness o bony enlargement o no palpable warmth 2. Pain score according to numerical rating scale (while standing) not less than 3 3. Willing to participate

Exclusion criteria

Exclusion criteria: 1 History of hypesensitivity herbal and naproxen 2 History of lower extremity surgery within 6 months prior to screening 3 Treatment with other drugs potentially affecting bone or cartilage metabolism such as o Chronic systematic corticosteroids o Glucosamine or chondroitin sulphate within 15 day prior to screening o Hyaluronate injection into the index knee within 6 months prior to screening o Diacerin treatment within 12 months prior to screening 4 Chronic kidney disease eGFR < 60 ml min 1 73 m2 5 History of drug or alcohol abuse 6 history of peptic ulcer disease, hepatic or renal impairment AST or ALT above normal range GFR below 30 ml min 1 73 m2

Design outcomes

Primary

Measure	Time frame
Total WOMAC of The modified Thai WOMAC scores Baseline, 2, 4 weeks between-group mean difference from baseline	—

Secondary

Measure	Time frame
Short Form Health Survey Version 2 Baseline, 2, 4 weeks between-group mean difference from baseline,4x10m fast-paced walk test Baseline, 2, 4 weeks between-group time mean difference from baseline,Time up and go test Baseline, 2, 4 weeks between-group time mean difference from baseline	—

Countries

Thailand

Contacts

Public ContactChitrada Kongkam

Faculty of Medicine, Thammasat University

chitrada@msu.ac.th0614145142

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026