Impact of evidence based formulated multivitamin-mineral” supplementation on fatigue scale and serum level cytokines in multiple sclerosis

Sinagene Pharmaceutical Company/ Nano Hayat Daru0 个研究点目标入组 100 人开始时间: 待定最近更新: 2018年2月22日

适应症

试验速览

暂无简介。

•Patients with definite diagnosis of multiple sclerosis according to McDonald (2010) criteria; Patients with Relapsing Remitting Multiple Sclerosis (RRMS) as the clinical course of disease; Patients must be at range of 18-45 years old; Patients should take every types of interferon for at least 3 months before the study; Patients should not take any supplements from at least 3 months before the study; The fatigue score of patients must be 21-84 based on MFIS questionnaire; Patients should not take any antidepressant SSRI, modafinil, bupropion and Amurel at least 3 months before the study. patients EDSS must be 0-6
•Exclusion criteria:
•Patients with definite diagnosis of severe liver disease, gallstones and pancreatitis, systemic diseases affecting the balance of Th1 / Th2 such as asthma and active viral disease, autoimmune diseases such as SLE and RA,inflammatory bowel disease, type I diabetes; Patients with abnormal result tests of serum ferritin, serum zinc, vitamin D; Patients with malnutrition (BMI less than 19) or obesity (BMI greater than 25); Patients with changes in drugs and diet during the study; ); Patients with known allergic reactions to vitamin supplements; Patients with Pregnancy; Patients with alcohol or drug addiction and Smoking; Patients that forget to use of more than 12 days of supplements (10% of supplementation); Patients with increasing in EDSS more than 1 unit during the study.

发起方

Sinagene Pharmaceutical Company/ Nano Hayat Daru