Zingiber and Acmella Against Knee Osteoarthritis

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Pain; Osteo Arthritis Knee

Treatments: Dietary Supplement: Zingiber officinale and Acmella oleracea

Study type: Interventional

Funder types: Other

Identifiers

NCT03907787

1206/15012017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

One-group pretest-posttest quasi-experimental design

Other group

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.

Treatment:

Dietary Supplement: Zingiber officinale and Acmella oleracea