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Zingiber and Acmella Against Knee Osteoarthritis

Primary Purpose

Pain, Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Zingiber officinale and Acmella oleracea
Sponsored by
Azienda di Servizi alla Persona di Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • established moderate knee OA (classification 1-3 according to Kellgren and Lawrence system for classification of knee OA)
  • Lequesne Index of 6-10; 3) Body Mass Index (BMI) between 22 and 30 kg/m2
  • aged 40-75
  • no drugs for OA, such as nonsteroidal anti-inflammatory drugs (NSAIDs).

Exclusion Criteria:

  • diabetes, metabolic disease, or neoplasia, as well as the patients with disabling diseases that could directly affect muscle weakness (such as neurological diseases, hip fractures, or amputations)

Sites / Locations

  • Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

One-group pretest-posttest quasi-experimental design

Arm Description

50 subjects with moderate knee osteoarthritis were supplied for four weeks with two tablets/day, each containing 350 mg of standardized extracts of Zingiber officinale and Acmella oleracea.

Outcomes

Primary Outcome Measures

Change in generic pain (Visual Analogue Scale)
Pain intensity measured both at motion and at rest, using the Visual Analogue Scale (VAS). VAS measures a characteristic or attitude ranging across a continuum of values and cannot be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The results are showed with a scale 0-10. 0 means no pain and 10 high pain.
Change in knee pain (WOMAC)
Assessment of knee pain by WOMAC (Western Ontario and McMaster Universities Arthritis) Index. The WOMAC pain scale consists of five questions that assess pain while walking on a flat surface, going up or down stairs, in bed at night, sitting or lying, and standing upright. The responses are recorded on a five-point Likert scale, with a higher score representing a greater level of pain. This scale is valid and reliable in hip and knee OA populations.
Change in knee functionality (TLKS)
Tegner Lysholm Knee function Scoring (TLKS). Each patient completed a self-report questionnaire, TLKS, related to knee symptoms and function. It includes eight items: Limp, Support, Locking, Instability, Pain, Swelling, Stair climbing and Squatting. Each possible response to the items gives an arbitrary score on an increasing scale with a maximum of 100, a higher score representing a higher ability.

Secondary Outcome Measures

Change Health-related quality of life: ShortForm36
Health-related quality of life, recorded by the Short Form 36 Health questionnaire (SF-36), a generic measure of health status designed for use in population surveys which consider body pain as a dimension of health status. This is a self-reporting questionnaire and outcomes are measured with 8 numbers that express 8 different aspects of quality of life. Scoring 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the given scoring key. all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.
Change in inflammatory blood markers (CRP) (mg/dl)
Inflammation markers in plasma: C-reactive protein (CRP) (mg/dl). High-Sensitivity CRP was determined by immunonephelometry (mg/dl).
Change in Total fat mass (Kg), free fat mass (Kg) and visceral adipose tissue (Kg).
Body composition by dual-energy X-ray absorptiometry (DXA). Body composition was measured at baseline by DXA, using a Lunar Prodigy DEXA (GE Medical Systems, Waukesha, WI). Free Fat mass (Kg), Fat mass and visceral fat (Kg) data were derived from DXA using the DXA Prodigy enCORE software (version 17; GE Healthcare).
Change in inflammatory blood markers (ERS) (mm)
Inflammation markers in plasma: erythrocyte sedimentation rate (ESR) (mm). The erythrocyte sedimentation rate (ESR) was analyzed by capillary photometry (mm).

Full Information

First Posted
March 26, 2019
Last Updated
April 5, 2019
Sponsor
Azienda di Servizi alla Persona di Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT03907787
Brief Title
Zingiber and Acmella Against Knee Osteoarthritis
Official Title
The Use of a New Food-grade Lecithin Formulation of Highly Standardized Ginger (Zingiber Officinale) and Acmella Oleracea Extracts for the Treatment of Pain and Inflammation in a Group of Subjects With Moderate Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
February 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda di Servizi alla Persona di Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
One-group pretest-posttest quasi-experimental design in which primary outcomes were: a) the evaluation of pain intensity, by a 30-days Visual Analogue Scale (VAS) and b) the assessment of knee function by Western Ontario and McMaster Universities Arthritis Index and by Tegner Lysholm Knee Scoring collected at baseline, at 15 and 30 days after treatment. Secondary outcomes were the evaluation: c) of Health-related quality of life, by the ShortForm36, d) of inflammation by C-reactive protein and Erythrocyte Sedimentation Rate, and e) of body composition by dual-energy X-ray absorptiometry measured at baseline and 30 days after treatment.
Detailed Description
To evaluate the safety and the efficacy on pain and inflammation of a new food-grade lecithin formulation of standardized extracts of Zingiber officinale and Acmella oleracea.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Osteo Arthritis Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One-group pretest-posttest quasi-experimental design
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
One-group pretest-posttest quasi-experimental design
Arm Type
Other
Arm Description
50 subjects with moderate knee osteoarthritis were supplied for four weeks with two tablets/day, each containing 350 mg of standardized extracts of Zingiber officinale and Acmella oleracea.
Intervention Type
Dietary Supplement
Intervention Name(s)
Zingiber officinale and Acmella oleracea
Intervention Description
Subjects were supplied for four weeks with two tablets/day and there was the evaluation of pain intensity, by a 30-days Visual Analogue Scale (VAS) and b) the assessment of knee function by Western Ontario and McMaster Universities Arthritis Index and by Tegner Lysholm Knee Scoring collected at baseline, at 15 and 30 days after treatment, Health-related quality of life, by the ShortForm36, inflammation by C-reactive protein and Erythrocyte Sedimentation Rate, body composition by dual-energy X-ray absorptiometry measured at baseline and 30 days after treatment.
Primary Outcome Measure Information:
Title
Change in generic pain (Visual Analogue Scale)
Description
Pain intensity measured both at motion and at rest, using the Visual Analogue Scale (VAS). VAS measures a characteristic or attitude ranging across a continuum of values and cannot be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The results are showed with a scale 0-10. 0 means no pain and 10 high pain.
Time Frame
0-15-30 days
Title
Change in knee pain (WOMAC)
Description
Assessment of knee pain by WOMAC (Western Ontario and McMaster Universities Arthritis) Index. The WOMAC pain scale consists of five questions that assess pain while walking on a flat surface, going up or down stairs, in bed at night, sitting or lying, and standing upright. The responses are recorded on a five-point Likert scale, with a higher score representing a greater level of pain. This scale is valid and reliable in hip and knee OA populations.
Time Frame
0-15-30 days
Title
Change in knee functionality (TLKS)
Description
Tegner Lysholm Knee function Scoring (TLKS). Each patient completed a self-report questionnaire, TLKS, related to knee symptoms and function. It includes eight items: Limp, Support, Locking, Instability, Pain, Swelling, Stair climbing and Squatting. Each possible response to the items gives an arbitrary score on an increasing scale with a maximum of 100, a higher score representing a higher ability.
Time Frame
0-15-30 days
Secondary Outcome Measure Information:
Title
Change Health-related quality of life: ShortForm36
Description
Health-related quality of life, recorded by the Short Form 36 Health questionnaire (SF-36), a generic measure of health status designed for use in population surveys which consider body pain as a dimension of health status. This is a self-reporting questionnaire and outcomes are measured with 8 numbers that express 8 different aspects of quality of life. Scoring 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the given scoring key. all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.
Time Frame
0-30 days
Title
Change in inflammatory blood markers (CRP) (mg/dl)
Description
Inflammation markers in plasma: C-reactive protein (CRP) (mg/dl). High-Sensitivity CRP was determined by immunonephelometry (mg/dl).
Time Frame
0-30 days
Title
Change in Total fat mass (Kg), free fat mass (Kg) and visceral adipose tissue (Kg).
Description
Body composition by dual-energy X-ray absorptiometry (DXA). Body composition was measured at baseline by DXA, using a Lunar Prodigy DEXA (GE Medical Systems, Waukesha, WI). Free Fat mass (Kg), Fat mass and visceral fat (Kg) data were derived from DXA using the DXA Prodigy enCORE software (version 17; GE Healthcare).
Time Frame
0-30 days
Title
Change in inflammatory blood markers (ERS) (mm)
Description
Inflammation markers in plasma: erythrocyte sedimentation rate (ESR) (mm). The erythrocyte sedimentation rate (ESR) was analyzed by capillary photometry (mm).
Time Frame
0-30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: established moderate knee OA (classification 1-3 according to Kellgren and Lawrence system for classification of knee OA) Lequesne Index of 6-10; 3) Body Mass Index (BMI) between 22 and 30 kg/m2 aged 40-75 no drugs for OA, such as nonsteroidal anti-inflammatory drugs (NSAIDs). Exclusion Criteria: diabetes, metabolic disease, or neoplasia, as well as the patients with disabling diseases that could directly affect muscle weakness (such as neurological diseases, hip fractures, or amputations)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariangela Rondanelli, PhD
Organizational Affiliation
IRCCS Mondino Foundation, Pavia, 27100 Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Zingiber and Acmella Against Knee Osteoarthritis

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