Efficacy and safety of Mitragynine gel in primary osteoarthritis knee ; Randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250717004

Enrollment

Registered

2025-07-17

Start date

2023-05-01

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

Primary knee osteoarthritis Primary knee osteoarthritis OA knee

Interventions

Mitragynine is a substance in Kratom that provides analgesic properties due to high affinity to mu opioid receptors and also has anti inflammatory properties by inhibiting COX2 mRNA and prostaglandin

Experimental Drug,Active Comparator Drug

Mitragynine gel ,Diclofenac gel

Eligibility

Sex/Gender

All

Age

50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age between 50 and 70 years 2. Primary OA of at least one knee KL I-III 3. Done inform consent

Exclusion criteria

Exclusion criteria: 1. Secondary osteoarthritis 2. Previous intraarticular corticosteroid use within 90days 3. History of peptic ulcer 4. Active liver/renal/cardiovascular diseases 5. Ongoing use of glucosamine or chondroitin within 90days 6. Concomitant skin disease or open skin lesion at application site 7. Deny inform consent 8. Kratom allergy 9. Paracetamol allergy 10. NSAIDs allergy

Design outcomes

Primary

Measure	Time frame
improvement of Western Ontario and McMaster Universities Osteoarthritis Index pain subscale 2weeks, 6weeks, 12weeks post treatment Western Ontario and McMaster Universities Osteoarthritis Index score	—

Secondary

Measure	Time frame
Satisfaction 2weeks, 6weeks, 12weeks post treatment Satisfaction score,improvement of Western Ontario and McMaster Universities Osteoarthritis Index stiffness subscale 2weeks, 6weeks, 12weeks post treatment Western Ontario and McMaster Universities Osteoarthritis Index score,improvement of Western Ontario and McMaster Universities Osteoarthritis Index physical function subscale 2weeks, 6weeks, 12weeks post treatment Western Ontario and McMaster Universities Osteoarthritis Index score,Safety 2weeks, 6weeks, 12weeks post treatment Liver enzyme level, Blood Urea Nitrogen level, Creatinine level	—

Measure

Time frame

Satisfaction 2weeks, 6weeks, 12weeks post treatment Satisfaction score,improvement of Western Ontario and McMaster Universities Osteoarthritis Index stiffness subscale 2weeks, 6weeks, 12weeks post treatment Western Ontario and McMaster Universities Osteoarthritis Index score,improvement of Western Ontario and McMaster Universities Osteoarthritis Index physical function subscale 2weeks, 6weeks, 12weeks post treatment Western Ontario and McMaster Universities Osteoarthritis Index score,Safety 2weeks, 6weeks, 12weeks post treatment Liver enzyme level, Blood Urea Nitrogen level, Creatinine level

—

Countries

Thailand

Contacts

Public ContactJarudej Deeprasertkul

Prince of Songkla University hospital

?jayyorwor68@gmail.com0888348312

Outcome results

None listed

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