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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01794260

Enrollment

100

Registered

2013-02-18

Start date

2012-12-31

Completion date

2013-12-31

Last updated

2013-02-18

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

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Moderate ot severe pain, ZINGIBER CASSUMUNAR ROXB

Brief summary

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

Interventions

DRUGCream from Zingiber cassumunar Roxb. extract

DRUGPlacebo cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index	week 8

Secondary

Measure	Time frame
Change from baseline of Pain visual analog scale (PVAS)	week 8
Change from baseline of Global assessment of disease status (GADS)	week 8
Clinical global impression of change (CGIC)	Week 8
Patient global impression of change (PGIC)	Week 8
Adverse events	Week 8

Countries

Thailand

Contacts

Primary ContactChuthamanee Suthisisang, Ph.D.

pycst@mahidol.ac.th662-644-8700

Backup ContactSuwimon Yeephu, M.Sc.

suwimony@swu.ac.th6686-9836644

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026