Derris Scandens Benth Extract VS Naproxen in Knee OA | NCT00503828

Studies
Derris Scandens Benth Extract VS Naproxen in Knee OA

NCT00503828

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jan 13, 2010Estimated

Enrollment

120Actual

Phase

Phase 3

Conditions

Knee Osteoarthritis

Interventions

Derris scandens Benth extracts
naproxen

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jul 18, 2007

First Submission Date that Met QC Criteria

Jul 18, 2007

First Posted Date

Jul 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2010

Last Update Posted Date

Jan 13, 2010Estimated

Name	Class
Ministry of Health, Thailand	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Derris Scandens Benth (family : Leguminosae) is a woody vine growing throughout Southeast Asia, including Thailand. The stem of D.Scandens has been widely use in Thai traditional medicine, foe example of myalgia. Previous study shown that D.Scandens Benth extract has the anti-inflammatory activity. Although NSAIDs are efficaciously in the treatment of osteoarthritis,but the GI side effect is still concerned. In this study we aim to investigate the efficacy and safety of D. Scandens Benth extract compared with Naproxen for therapy of patients with knee osteoarthritis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
naproxen	Active Comparator	Naproxen 500 mg/day for 4 weeks	Drug: naproxen
Derris Scandens Benth	Experimental	Derris Scandens Benth	Drug: Derris scandens Benth extracts

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Derris scandens Benth extracts	Drug	Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks	Derris Scandens Benth

Measure	Description	Time Frame
WOMAC score		2, 4 weeks

Measure	Description	Time Frame
6-minute walk, Quality of Life, adverse event		2, 4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >=50 yr
Known case of primary knee osteoarthritis
WOMAC pain subscale (item1) >= 5
signed informed consent

Exclusion Criteria:

hypersensitive to NSAIDs
history of peptic ulcer or melena
unable to walk , i.e. patient with severe spinal stenosis, myocardial infarction
history of intra-articular injection of knee within 3 months
status post knee replacement

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vilai Kuptniratsaikul, Assoc.Prof.	Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Siriraj Hospital		Bangkoknoi	Bangkok	10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009288	Naproxen

Ancestor Terms

ID	Term
D009280	Naphthaleneacetic Acids
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided