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EFFICACY AND SAFETY OF TOPICAL SAHASTARA EXTRACT CREAM IN PRIMARY KNEE OSTEOARTHRITIS COMPARED WITH DICLOFENAC GEL AND CAPSICUM GEL (CLINICAL TRIAL PHASE III)

EFFICACY AND SAFETY OF TOPICAL SAHASTARA EXTRACT CREAM IN PRIMARY KNEE OSTEOARTHRITIS COMPARED WITH DICLOFENAC GEL AND CAPSICUM GEL (CLINICAL TRIAL PHASE III)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260510003
Enrollment
263
Registered
2026-05-10
Start date
2019-08-08
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

Osteoarthritis is the most prevalent chronic arthropathy worldwide, and its impact on public health continues to grow with the aging global population. Sahastara, topical cream,knee osteoarthritis, diclofenac gel, capsicum gel

Interventions

1% w/w of Sahastara remedy extract (Patent No. 1301004523),1% diclofenac gel purchased from DKSH (Thailand) CO., LTD. (1A 752/41) ,0.025% w/w of capsaicin purchased from Bangkok Drug (Thailand) CO.,
Sahastara extract cream,Diclofenac gel,Capsicum gel

Sponsors

Center of Excellence in Applied Thai Traditional Medicine Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Not during pregnancy. 2.Patients are primary OA of the knee for more than three months were recruited. 3.The diagnosis of OA of the knee was based on the American College of Rheumatology clinical and radiographic criteria with 1-3 stage of Kellgren Lawrence stage and baseline of pain scores by VAS have not less than 3.

Exclusion criteria

Exclusion criteria: 1.overweight (BMI > 32 ) 2.underlying arthritis (e.g., rheumatoid arthritis or gouty arthritis) 3.uncontrolled hypertension (>140/90 mmHg), Heart diseases (congenital valve disease, arrhythmia, heart failure), liver diseases, renal diseases, condition requiring knee surgery in the next few months use of intra-articular corticosteroid injections in the past three months

Design outcomes

Primary

MeasureTime frame
Efficacy 28 days Western Ontario and McMaster Universities Osteoarthritis Index Scores

Secondary

MeasureTime frame
Efficacy 28 ays Thai Knee Injury and Osteoarthritis Outcome Score

Countries

Thailand

Contacts

Public ContactChakrapanpong Threrapanithan

Faculty of Medicine, Thammasat University

champkub@tu.ac.th0800499829

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026