Treatment of Patients With Chronic Osteoarthritis With Gi... | NCT02044432

Studies
Treatment of Patients With Chronic Osteoarthritis With Ginger Kidney Compress - a Randomized, Controlled Trial

NCT02044432

Sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Status

Completed

Last Update Posted

Aug 9, 2019Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

ginger compress

Countries

Not provided

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

Aug 2019

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

Jan 2014

Primary Completion Date

Jul 2015Actual

Completion Date

Dec 2017Actual

First Submitted Date

Jan 10, 2014

First Submission Date that Met QC Criteria

Jan 22, 2014

First Posted Date

Jan 24, 2014Estimated

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

Aug 7, 2019

Last Update Posted Date

Aug 9, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Jan Vagedes, Dr. Jan Vagedes MD, ARCIM Institute Academic Research in Complementary and Integrative MedicinePrincipal Investigator

Lead Sponsor

ARCIM Institute Academic Research in Complementary and Integrative MedicineOTHER

Collaborators

Not provided

Description Module

Brief Summary

The investigators hypothesize that by a 5-week treatment with ginger kidney compresses at least 2 of 3 main symptoms of the WOMAC (pain, stiffness, functionality) will be reduced at least 30% at the time of the post-measurement (after 5 weeks of therapy) in comparison to the respective control group (waitlist).

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ginger compress	Experimental		Other: ginger compress
Wait list	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ginger compress	Other	Kidney ginger compress	Ginger compress

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Sum Score (WOMAC)		Change from baseline at 5 weeks of treatment and 5 weeks follow up

Secondary Outcomes

Measure	Description	Time Frame
Change in medication		After 5 weeks of treatment and 5 weeks follow up

Other Outcomes

Measure	Description	Time Frame
Sum Score of "Short Arthritis Assessment Scale" questionnaire		After 5 weeks of treatment and 5 weeks follow up
Parameters of a warmth questionnaire		After 5 weeks of treatment and 5 weeks follow up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic osteoarthritis, mainly osteoarthritis of the knee
osteoarthritis symptoms for at least six months
written consent to participate in the study
Age: 30 years and more

Exclusion Criteria:

Rheumatoid Arthritis
Fibromyalgia
Oncological or other serious diseases
Use of corticosteroids
Nephropathy
Non-intact skin conditions in the area of application
Hypersensitivity / allergy to ginger
Simultaneous participation in another clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
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