Arabic
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

Study Evaluating the Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis

يمكن للمستخدمين المسجلين فقط ترجمة المقالات
الدخول التسجيل فى الموقع
يتم حفظ الارتباط في الحافظة
الحالة
الرعاة
Zhejiang University
المتعاونون
Sir Run Run Shaw Hospital

الكلمات الدالة

نبذة مختصرة

Previous study found that lipid extract from hard-shelled mussel (HMLE) at a dose of 100mg/kg possessed strong anti-inflammatory activity by diminishing the hind paw swelling and arthritis index in rat model. In the present study, HMLE was processed to capsules under strict food safety supervision and patients with active rheumatoid arthritis (RA)were selected to examine whether supplementation with HMLE could improve clinical and laboratory parameters of disease activity. The validated disease activity score that include 28 joint counts and ESR (DAS28) and validated clinical disease activity index (CDAI) were primary outcome measure. Laboratory parameters including IL-1β, IL-6, IL-10, TNF-α,PGE2 and COX-2 were also measured to explore the mechanisms.

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

Rheumatoid Arthritis

التدخل / العلاج

Dietary Supplement: Mussel oil capsules

Dietary Supplement: Corn oil capsuels

مرحلة

-

مجموعات الذراع

ذراعالتدخل / 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 للدراسةAll
يقبل المتطوعين الأصحاءنعم
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)]

The validated disease activity score that include 28 joint counts and ESR (DAS28) were primary outcome measure. DAS28 was calculated as the formula: DAS28=[0.56*sqrt(T28)+0.28*sqrt(SW28)+0.70*Ln(ESR)]*1.08+0.16. T28: Tender joint count; SW28: Swollen joint count; ESR: Erythrocyte sedimentation rate. T28 and SW28 were determined by a professional doctor who was blind to the patient groups and ESR (Westergreen's method) was analyzed on Monitor 20 (VITAL Diagnostics, Italy).

تدابير النتائج الأخرى

1. C-reactive protein [6 months (3-month intervals)]

Fasting blood specimens were obtained from all participants at entry, 12 and 24 wk later. C-reactive protein was analyzed on HITACHI 7020 chemistry analyzer using enzymebased colorimetric test or colorimetric test supplied by DiaSys Diagnostic Systems (Shanghai) Co., Ltd. within four hours of blood collection.

2. Rheumatoid factor [6 months (3-month intervals)]

Fasting blood specimens were obtained from all participants at entry, 12 and 24 wk later.Rheumatoid factor were analyzed on HITACHI 7020 chemistry analyzer using enzymebased colorimetric test or colorimetric test supplied by DiaSys Diagnostic Systems (Shanghai) Co., Ltd. within four hours of blood collection.

3. Prostaglandin E2 (PGE2) [6 months (3-month intervals)]

Levels of PGE2 from serum were determined by the research workers who were blind to the patient groups using ELISA Kits (Nanjing Jiancheng Technology Co., Lte., Nanjing, China), according to the manufacturer's instructions.

4. Interleukin-1β(IL-1β) [6 months (3-month intervals)]

Levels of IL-1β from serum were determined by the research workers who were blind to the patient groups using ELISA Kits (Nanjing Jiancheng Technology Co., Lte., Nanjing, China), according to the manufacturer's instructions.

5. Tumor necrosis factor-α (TNF-α) [6 months (3-month intervals)]

Levels of TNF-α from serum were determined by the research workers who were blind to the patient groups using ELISA Kits (Nanjing Jiancheng Technology Co., Lte., Nanjing, China), according to the manufacturer's instructions.

6. Interleukin-6 (IL-6) [6 months (3-month intervals)]

Levels of IL-6 from serum were determined by the research workers who were blind to the patient groups using ELISA Kits (Nanjing Jiancheng Technology Co., Lte., Nanjing, China), according to the manufacturer's instructions.

7. Interleukin-10 (IL-10) [6 months (3-month intervals)]

Levels IL-10 from serum were determined by the research workers who were blind to the patient groups using ELISA Kits (Nanjing Jiancheng Technology Co., Lte., Nanjing, China), according to the manufacturer's instructions.

انضم إلى صفحتنا على الفيسبوك

قاعدة بيانات الأعشاب الطبية الأكثر اكتمالا التي يدعمها العلم

  • يعمل في 55 لغة
  • العلاجات العشبية مدعومة بالعلم
  • التعرف على الأعشاب بالصورة
  • خريطة GPS تفاعلية - ضع علامة على الأعشاب في الموقع (قريبًا)
  • اقرأ المنشورات العلمية المتعلقة ببحثك
  • البحث عن الأعشاب الطبية من آثارها
  • نظّم اهتماماتك وابقَ على اطلاع دائم بأبحاث الأخبار والتجارب السريرية وبراءات الاختراع

اكتب أحد الأعراض أو المرض واقرأ عن الأعشاب التي قد تساعد ، واكتب عشبًا واطلع على الأمراض والأعراض التي تستخدم ضدها.
* تستند جميع المعلومات إلى البحوث العلمية المنشورة

Google Play badgeApp Store badge