Study Evaluating the Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis
الكلمات الدالة
نبذة مختصرة
وصف
In this randomized controlled design, patients continued receiving background medications (slow-acting anti-rheumatic drugs and non-steroidal anti-inflammatory drugs) without change and were assigned to two groups. The first group (G1) received daily four mussel oil capsules (containing 800mg mussel oil and 800mg corn oil) for first two months and two mussel oil capsules per day thereafter. The second group (G2) received corn oil capsules (400mg corn oil per capsule) according to the same regimen. All patients were asked to keep a 7-day food diary before intervention and during wk 12. Dietary energy and nutrient intake of each subject during the preexperimental and study period were assessed from the dietary records by using "Diet Analysis" software (Cao Aihong, Taiyuan, China). All the enrolled patients visited Zhejiang Sir Run Run Shaw Hospital in the morning following an overnight fast at baseline and 3-month intervals, and underwent anthropometric measurements including height, body weight, waist circumference, hip circumference, heart rate and blood pressure. Then clinical evaluations were performed during face-to-face interview by a professional attending doctor and ten milliliter of peripheral venous blood was drawn. Serum and erythrocyte samples were also promptly processed and frozen at -80℃ until analysis.
تواريخ
آخر التحقق: | 05/31/2014 |
تم الإرسال لأول مرة: | 06/21/2014 |
تم إرسال التسجيل المقدر: | 06/22/2014 |
أول نشر: | 06/24/2014 |
تم إرسال آخر تحديث: | 06/22/2014 |
آخر تحديث تم نشره: | 06/24/2014 |
تاريخ بدء الدراسة الفعلي: | 01/31/2014 |
تاريخ الإنجاز الأساسي المقدر: | 06/30/2014 |
التاريخ المتوقع لانتهاء الدراسة: | 06/30/2014 |
حالة أو مرض
التدخل / العلاج
Dietary Supplement: Mussel oil capsules
Dietary Supplement: Corn oil capsuels
مرحلة
مجموعات الذراع
ذراع | التدخل / العلاج |
---|---|
Experimental: Mussel oil capsules Four mussel oil capsules (containing 800mg mussel oil and 800mg corn oil) per day for first two months and two mussel oil capsules (containing 400mg mussel oil and 400mg corn oil) per day thereafter for four months. | Dietary Supplement: Mussel oil capsules Each mussel oil capsule contained 200mg thick shell mussel lipid extract and 200mg corn oil.Each patient in this group received daily four mussel oil capsules (containing 800mg mussel oil and 800mg corn oil) for first two months and two mussel oil capsules per day thereafter |
Placebo Comparator: Corn oil capsuels Four corn oil capsules (containing 1600mg corn oil) for first two months and two mussel oil capsules (containing 800mg corn oil) per day thereafter for four months. | Dietary Supplement: Corn oil capsuels Each corn oil capsule contained 400mg corn oil.Each patient in this group received daily four corn oil capsules (1600mg corn oil) for first two months and two corn oil capsules per day thereafter |
معايير الأهلية
الأعمار المؤهلة للدراسة | 18 Years إلى 18 Years |
الأجناس المؤهلة للدراسة | All |
يقبل المتطوعين الأصحاء | نعم |
المعايير | Inclusion Criteria: - According to the American College of Rheumatology criteria, patients from Zhejiang province with active RA were included in this study and all participants were Chinese. Patients had at least 3 swollen joints and 6 tender joints or had an erythrocyte sedimentation rate (ESR) of >28mm/hr or morning stiffness of at least 45 min were classified as with active disease. Exclusion Criteria: - Subjects suffering hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems, liver and renal failure. |
النتيجة
مقاييس النتائج الأولية
1. Disease activity score that include 28 joint counts and ESR (DAS28) [Six months (3-month intervals)]
تدابير النتائج الأخرى
1. C-reactive protein [6 months (3-month intervals)]
2. Rheumatoid factor [6 months (3-month intervals)]
3. Prostaglandin E2 (PGE2) [6 months (3-month intervals)]
4. Interleukin-1β(IL-1β) [6 months (3-month intervals)]
5. Tumor necrosis factor-α (TNF-α) [6 months (3-month intervals)]
6. Interleukin-6 (IL-6) [6 months (3-month intervals)]
7. Interleukin-10 (IL-10) [6 months (3-month intervals)]