A Randomized controlled trial : Efficacy of Drug-free gel containing ultra-deformable phospholipid vesicles (TDT-064) in osteoarthritic knee

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190302001

Enrollment

Registered

2019-03-02

Start date

2019-03-01

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

Osteoarthritis Osteoarthritis ultra&#45

Interventions

Drug&#45

free gel containing ultra&#45

deformable phospholipid vesicles (TDT&#45

064) apply at osteoarthritic knee twice daily,Placebo gel apply at osteoarthritic knee twice daily

Experimental Drug,Placebo Comparator No treatment

TDT&#45

064,Control

Eligibility

Sex/Gender

All

Age

45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. osteoarthris : Kellgren and Lawrence classification level 2-3 2. able to walk without gait aids

Exclusion criteria

Exclusion criteria: 1. Previous surgery around the affected knee 2. Systemic arthritis conditions 3. Have abnormal neurological function and other lower musculoskeletal problem 4. Documented allergy to drug in the study 5. Skin diseases or problem around knee 6. Chronic kidney disease with CrCl <30 ml/min

Design outcomes

Primary

Measure	Time frame
Pain 2 week, 6 week, 3 month Verbal numerical pain score	—

Secondary

Measure	Time frame
Functional score 2 week, 6 week, 3 month Knee and Osteoarthritis Outcome Score (KOOS)	—

Countries

Thailand

Contacts

Public ContactVarah Yuenyongviwat

Faculty of Medicine, Prince of Songkla university

varahortho@gmail.com074451601

Outcome results

None listed

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

A Randomized controlled trial : Efficacy of Drug&#45;free gel containing ultra&#45;deformable phospholipid vesicles (TDT&#45;064) in osteoarthritic knee