OsteoarthritisPhase 2/3NCT01794260
Efficacy and Safety of Topical Essential Oil Extracted From Zingiber Cassumunar Rokb in Osteoarthritis
A Phase 2/3 study testing Cream from Zingiber cassumunar Roxb. extract in people with Osteoarthritis, run by Mahidol University at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Cream from Zingiber cassumunar Roxb. extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2012to Dec 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Srinakharinwirot University
Ongkarak, Changwat Nakhon Nayok, 26120
Chuthamanee Suthisisang, Ph.D, 662-644-8700, pycst@mahidol.ac.th
Suwimon Yeephu, M.Sc., 6686-9836644, suwimony@swu.ac.th
About this study
Official title: Efficacy and Safety of Topical Preparation of Essential Oil Extracted From Zingiber Cassumunar Rokb in Patients With Osteoarthritis
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
- Conditions
- Osteoarthritis
- Being tested
- Cream from Zingiber cassumunar Roxb. extract, Placebo cream
- Keywords
- Osteoarthritis, Moderate ot severe pain, ZINGIBER CASSUMUNAR ROXB
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cream from Zingiber cassumunar Roxb. extractDrug
Placebo creamDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo cream | Placebo comparator | Placebo cream Receives: Drug: Placebo cream |
| Plai cream | Experimental | Cream from Zingiber cassumunar Roxb. extract Receives: Drug: Cream from Zingiber cassumunar Roxb. extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index
Measured: week 8
Secondary outcomes (5)
Change from baseline of Pain visual analog scale (PVAS)
Measured: week 8
Change from baseline of Global assessment of disease status (GADS)
Measured: week 8
Clinical global impression of change (CGIC)
Measured: Week 8
Patient global impression of change (PGIC)
Measured: Week 8
Adverse events
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chuthamanee Suthisisang, Ph.D., Study director, Department of Pharmacology, Faculty of Pharmacy, Mahidol University 447 Sri-Ayudhya Rd., Rajthevee, Bangkok 10400, ThailandSuwimon Yeephu, M.Sc., Principal investigator, Faculty of Pharmacy, Srinakharinwirot UniversityChuthamanee Suthisisant, Ph.D, Study chair, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794260
- Sponsor's protocol ID
- AFTA-01
- Status last verified
- Dec 2012
- First submitted
- 11 Dec 2012
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Preparation of Essential Oil Extracted From Zingiber Cassumunar Rokb in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT01794260
- Acronym / sponsor ID
- AFTA-01
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Moderate ot severe pain, ZINGIBER CASSUMUNAR ROXB
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo cream | Placebo comparator | Drug: Placebo creamPlacebo cream |
| Plai cream | Experimental | Drug: Cream from Zingiber cassumunar Roxb. extractCream from Zingiber cassumunar Roxb. extract |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cream from Zingiber cassumunar Roxb. extract | Drug | Plai cream |
| Placebo cream | Drug | Placebo cream |
Primary outcome
Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index
Time frame: week 8
5 secondary outcomes
Change from baseline of Pain visual analog scale (PVAS)
Time frame: week 8
Change from baseline of Global assessment of disease status (GADS)
Time frame: week 8
Clinical global impression of change (CGIC)
Time frame: Week 8
Patient global impression of change (PGIC)
Time frame: Week 8
Adverse events
Time frame: Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuthamanee Suthisisang, Ph.D. study director
Department of Pharmacology, Faculty of Pharmacy, Mahidol University 447 Sri-Ayudhya Rd., Rajthevee, Bangkok 10400, Thailand
Suwimon Yeephu, M.Sc. principal investigator
Faculty of Pharmacy, Srinakharinwirot University
Chuthamanee Suthisisant, Ph.D study chair
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cream from Zingiber cassumunar Roxb. extract in people with Osteoarthritis, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuthamanee Suthisisang, Ph.D. (662-644-8700, pycst@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of The WOMAC (Western Ontario and McMaster Universities) index (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2013.