Zingiber and Acmella Against Knee Osteoarthritis

NCT03907787 | Completed DMC

• 1 other identifier: 1206/15012017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (3)

• 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.

  0-15-30 days

• 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.

  0-15-30 days

• 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.

  0-15-30 days

Secondary Outcomes (4)

• Change Health-related quality of life: ShortForm36

  0-30 days

• Change in inflammatory blood markers (CRP) (mg/dl)

  0-30 days

• Change in Total fat mass (Kg), free fat mass (Kg) and visceral adipose tissue (Kg).

  0-30 days

• Change in inflammatory blood markers (ERS) (mm)

  0-30 days

Study Arms (1)

One-group pretest-posttest quasi-experimental design

OTHER

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

Interventions

Zingiber officinale and Acmella oleracea DIETARY_SUPPLEMENT

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.

One-group pretest-posttest quasi-experimental design

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

Study Sites (1)

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

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Pain

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mariangela Rondanelli, PhD

  IRCCS Mondino Foundation, Pavia, 27100 Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One-group pretest-posttest quasi-experimental design

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 9, 2019
• Study Start: February 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: February 15, 2018
• Last Updated: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)