Effect of Ginko and Cistanche Against Fatigue Symptoms
Condition: Mental Fatigue; Fatigue; Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue; Mental Fatigue
Study type: Interventional

Summary: 
      To evaluate the efficacy of Nutrilite® ginkgo biloba cistanche tablets in relieving the
      symptoms of chronic fatigue syndrome(CFS), the investigators randomly recruit189 subjects
      with CFS, aged 35-60 yrs. The relief of fatigue and improvement of sexual function are
      evaluated by World Health Organization Quality Of Life Brief (WHOQoL-Bref), Sexual Life
      Quality Questionnaire (SLQQ), chronic fatigue syndrome, symptoms of self-assessment at the
      baseline and the end of intervention. Subjects also underwent a blood test measuring the
      concentration of biochemical indicators. Cistanche is mainly used to strengthen the renal
      function, nourish essence and blood in the treatment of lumbar debility, impotence,
      infertility and muscles weakness, constipation. etc. The study is to test the hypothesis that
      consecutive 60-day intake of the study tablets can relieve the symptoms of CFS; according to
      the change of blood biology indicators, the investigators will also evaluate the association
      between the change of plasma outcome measures and chronic fatigue syndrome.
    

Detailed description: 
      Chronic fatigue syndrome (CFS) is the common name for a group of significantly debilitating
      medical conditions characterized by persistent fatigue and other specific symptoms that lasts
      for a minimum of six months in adults. Symptoms of CFS include malaise after exertion;
      unrefreshing sleep, physical exhaustion, sore throat, headaches, widespread muscle and joint
      pain, and depression. The cause of CFS is unclear, but appears to result from a multiple
      factors. Generally, the onset of CFS is associated with psychological stress, endocrine and
      immune disorder, genetic factors, and viral infections the diagnostic criteria for CFS
      modified by Fukuda,etc.in 1994. Currently, there is no one common treatment for CFS.
      regularly used treatments include the medications which enhance immunity system and
      nutrition-balanced therapy, Cognitive behavioural therapy (CBT), , local physiotherapy, , and
      graded exercise therapy(GET).The main purposes of the treatments are to relieve CFS symptoms,
      improve the psychological condition and social function. According to the U.S. Centers for
      Disease Control and Prevention (CDC) , CFS will become one of the main diseases that affect
      human health.

      Cistanche, is a desert plants in the family Orobanchaceae. It mainly grows in the sandy
      pastures of Inner Mongolia, Gansu and Xinjiang Province of China. The plants of the best
      quality is from Inner Mongolia. According to Traditional Chinese Medical theories, its nature
      and flavour is sweet, salty, warm, and goes into kidney, large intestine meridians. It is
      commonly used to invigorate the renal function, nourish essence and blood in the treatment of
      lumbar debility, impotence, infertility and muscles weakness, and regulates the intestinal
      tract environment such as dryness, and constipation. A clinical trial showed that Cistanche
      granules relieved kidney deficiency symptoms in 86.7% of the chronic fatigue syndrome
      patients, demonstrated a significant difference comparing post-intervention to baseline (P
      <0.01).

      Ginko As recorded in the Yuan Herbal Classic by Lulu Zhang Feng in Qing Dynasty, ginkgo has
      functions of reducing phlegm, detoxification, insect killing, could cure scabies and gangrene
      tumors, acute mastitis ulceration disease, dental caries, infantile diarrhea, leukorrhea with
      reddish discharge, chronic stranguria with turbid discharge, emission enuresis disease.

      In addition, ginkgo can inhibit various types of pathogenic bacteria. A clinical study
      (conducted by Wuhan Military General Hospital) of over 100 subjects with high cholesterol
      showed that ginkgo extract (guanxin ketones) has antihypertensive effect.

      Germany, United Kingdom, France, USA and South Korea also used ginkgo leaves to produce drugs
      for treating cardiovascular and cerebrovascular diseases.

      Ginkgo root, containing ginkgo lactone C, M, A, B, is sweet, warm, plain and nontoxic, and
      can be used to treat leucorrhea disease and emission.

      A study about late Alzheimer disease found that ginkgo can improve vascular patency, thus has
      notable effect in anti-aging of brain function in elderly people, and enhancing memories.

      Subjects with ginkgo juice supplement showed significant improvement in memory, attention and
      complex movements compared to the control group, patients who take ginkgo juice have
      significantly improved.
    

Intervention name(s): Experimental: Nutrilite® Low dose; Experimental: Nutrilite® High dose; Placebo Comparator: Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Two tablets consume daily with meal.; Two tablets consume daily with meal.; Two tablets consume daily with meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention