Efficacy and Safety of Topical Essential Oil Extracted From Zingiber Cassumunar Rokb in Osteoarthritis

Mahidol University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: Placebo cream; Drug: Cream from Zingiber cassumunar Roxb. extract

Study type: Interventional

Funder types: Other

Identifiers

NCT01794260

AFTA-01

Details and patient eligibility

About

The objectives of this study are to assess short term efficacy and safety of of topical preparation of essential oil extracted from ZINGIBER CASSUMUNAR ROXB in patients suffering from osteoarthritic pain

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis: osteoarthritis of the knee at least on side with standard radiologic method within 6 weeks (Kellgren-Lawrence radiographic grading scale at least 1)
• Pain visual analog scale at rest at least 40 mm
• No previous analgesic treatment or receiving stable dose of analgesic drugs at least 2 weeks. If previously treated with antidepressants, glucosamine, chondroitin or diacerein, dosage should be stable for at least 3 months.
• Agree to attain non-pharmacologic treatment as prior to participate the study

Exclusion criteria

• having an open wound or abnormal skin at site of application
• having diagnose with other chronic arthritis such as rheumatoid arthritis
• history of allergy to the extraction of Zingiber cassumunar Roxb
• pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo cream

Placebo Comparator group

Description:

Placebo cream

Treatment:

Drug: Placebo cream

Plai cream

Experimental group

Description:

Cream from Zingiber cassumunar Roxb. extract

Treatment:

Drug: Cream from Zingiber cassumunar Roxb. extract