NCT02044432

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

January 10, 2014

Last Update Submit

August 7, 2019

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Total Sum Score (WOMAC)

    Change from baseline at 5 weeks of treatment and 5 weeks follow up

Secondary Outcomes (1)

  • Change in medication

    After 5 weeks of treatment and 5 weeks follow up

Other Outcomes (4)

  • 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

  • Range of knee movement

    After 5 weeks of treatment and 5 weeks follow up

  • +1 more other outcomes

Study Arms (2)

Ginger compress

EXPERIMENTAL
Other: ginger compress

Wait list

NO INTERVENTION

Interventions

ginger compressOTHER

Kidney ginger compress

Ginger compress

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Jan Vagedes MD

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 24, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

December 1, 2017

Last Updated

August 9, 2019

Record last verified: 2019-08