Zingiber and Acmella Against Knee Osteoarthritis
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
Paskutinį kartą patikrinta: | 03/31/2019 |
Pirmasis pateikimas: | 03/25/2019 |
Numatytas registravimas pateiktas: | 04/04/2019 |
Pirmas paskelbtas: | 04/08/2019 |
Paskutinis atnaujinimas pateiktas: | 04/04/2019 |
Paskutinis atnaujinimas paskelbtas: | 04/08/2019 |
Faktinė studijų pradžios data: | 01/31/2017 |
Numatoma pirminio užbaigimo data: | 12/30/2017 |
Numatoma studijų užbaigimo data: | 02/14/2018 |
Būklė ar liga
Intervencija / gydymas
Dietary Supplement: One-group pretest-posttest quasi-experimental design
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
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: One-group pretest-posttest quasi-experimental design 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. |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 40 Years Į 40 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | 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) |
Rezultatas
Pirminės rezultatų priemonės
1. Change in generic pain (Visual Analogue Scale) [0-15-30 days]
2. Change in knee pain (WOMAC) [0-15-30 days]
3. Change in knee functionality (TLKS) [0-15-30 days]
Antrinės rezultatų priemonės
1. Change Health-related quality of life: ShortForm36 [0-30 days]
2. Change in inflammatory blood markers (CRP) (mg/dl) [0-30 days]
3. Change in Total fat mass (Kg), free fat mass (Kg) and visceral adipose tissue (Kg). [0-30 days]
4. Change in inflammatory blood markers (ERS) (mm) [0-30 days]