Zingiber and Acmella Against Knee Osteoarthritis

April 5, 2019 updated by: Azienda di Servizi alla Persona di Pavia

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: One-group pretest-posttest quasi-experimental design
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.
Dietary supplement: Zingiber officinale and Acmella oleracea
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in generic pain (Visual Analogue Scale)
Time Frame: 0-15-30 days
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.
0-15-30 days
Change in knee pain (WOMAC)
Time Frame: 0-15-30 days
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.
0-15-30 days
Change in knee functionality (TLKS)
Time Frame: 0-15-30 days
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.
0-15-30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change Health-related quality of life: ShortForm36
Time Frame: 0-30 days
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.
0-30 days
Change in inflammatory blood markers (CRP) (mg/dl)
Time Frame: 0-30 days
Inflammation markers in plasma: C-reactive protein (CRP) (mg/dl). High-Sensitivity CRP was determined by immunonephelometry (mg/dl).
0-30 days
Change in Total fat mass (Kg), free fat mass (Kg) and visceral adipose tissue (Kg).
Time Frame: 0-30 days
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).
0-30 days
Change in inflammatory blood markers (ERS) (mm)
Time Frame: 0-30 days
Inflammation markers in plasma: erythrocyte sedimentation rate (ESR) (mm). The erythrocyte sedimentation rate (ESR) was analyzed by capillary photometry (mm).
0-30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda di Servizi alla Persona di Pavia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mariangela Rondanelli, PhD, IRCCS Mondino Foundation, Pavia, 27100 Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1206/15012017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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