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Effect of Ginko and Cistanche Against Fatigue Symptoms (GkoCist)

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ClinicalTrials.gov Identifier: NCT02807649
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Collaborators:
Sinphar Pharmaceutical Co., Ltd
SPRIM China (Shanghai) Consulting Co., LTD.
Fudan University
Information provided by (Responsible Party):
Access Business Group

Brief 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.

Condition or disease Intervention/treatment Phase
Mental Fatigue Fatigue Chronic Fatigue Syndrome Dietary Supplement: Experimental: Nutrilite® Low dose Dietary Supplement: Experimental: Nutrilite® High dose Dietary Supplement: Placebo Comparator: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A 60-Day Clinical Study to Evaluate Nutrilite Ginko Biloba Cistanche Tablets in Relieving the Symptoms of Chronic Fatigue Syndromes Compared to Negative Control
Study Start Date : May 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo: Methyl cellulose and dextrose
Dietary Supplement: Placebo Comparator: Placebo
Two tablets consume daily with meal.

Active Comparator: Low dose
This blend contains Ginko at 120 mg/day and Cistanche at 300 mg/day
Dietary Supplement: Experimental: Nutrilite® Low dose
Two tablets consume daily with meal.

Active Comparator: High dose
This blend contains Ginko at 180 mg/day and Cistanche at 450 mg/day
Dietary Supplement: Experimental: Nutrilite® High dose
Two tablets consume daily with meal.




Primary Outcome Measures :
  1. Net change in the score of World Health Organization Quality of Life survey before and after intervention [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Net change in the score of Chalder fatigue scale survey before and after intervention [ Time Frame: 60 days ]
  2. Net change in the score of Chalder fatigue self assessment survey before and after intervention [ Time Frame: 60 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be diagnosed as CFS by general practitioner and at least have four symptoms:

memory loss or lack of concentration, muscle pain, sleep disturbances, continuous discomfort after labor; Or be diagnosed as CFS according to the clinical diagnosis 30-60 days before screening;

  • Have normal electrocardiograms (ECG) and blood pressure during quiet respiration and during exercises.
  • Be willing to use reliable contraception methods during the study period (only for volunteers with fertility).
  • Agree not to take any medication, supplement or nutrition with promoting function to exercise capacity;
  • Be willing to comply with all the requirements and procedures of the study;
  • Agree to sign the informed consent form;
  • Fully understand the nature, objective and the potential risks and side effects of the study.

Exclusion Criteria:

  • BMI≧28;
  • Female on menopausal;
  • Have participated in similar clinical trials within 6 months before the screening;
  • Currently taking medicines for cardiovascular or metabolic disease ;
  • Have flu/symptoms of viral infection within three months before the first visit;
  • Have history of or be diagnosed of any of the following diseases that may affect the study results: gastrointestinal disorders, hepatopathy, nephropathy, endocrine disease, blood disorders, respiratory and cardiovascular diseases;
  • Current or previous alcohol abuser, currently taking or took illicit drugs, substance or over the counter prescription drugs which promote athletic performance;
  • Subject with iron-deficiency anemia, diabetes mellitus, epilepsy, bleeding tendency or Coagulation disorders;
  • Currently suffering from any gastrointestinal disorders or skeletal muscle dysfunction, including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, osteoporosis or arthritis;
  • Currently having or had any medical or nutritious therapies, including taking protein supplements or nutrients that promote exercise capacity within 3 months before screening;
  • Have lost or gained weight over 5 kilograms within 3 months before screening;
  • Had hospitalizations within 3 months before screening;
  • According to investigator's judgement, current frequent users of drugs which may affect the electrolyte balance or hydration.
  • Pregnant or nursing female, as determined by a questionnaire.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807649


Sponsors and Collaborators
Access Business Group
Sinphar Pharmaceutical Co., Ltd
SPRIM China (Shanghai) Consulting Co., LTD.
Fudan University
Investigators
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Principal Investigator: Shuguang Li, PhD Fudan University, Department of Nutrition and Food Hygiene

Publications:
1. Li Y, He DJ, Jiang ZL, Wu YQ and al. Studies on Emotional characteristics of individuals with chronic fatigue syndrome. China Journal of rehabilitation medicine, 2006, 21(3):218-220
2. Zhang J. Clinical study on behavior intervention in chronic fatigue syndrome. Liaoning Journal of Traditional Chinese Medicine, 2009, 36(8):1338-1340.
4. Shen XH, Zheng L, Zhu WR, Xu JZ, Chen JX and al. Clinical effect observation of Cistanch Yishen granule in the treatment of kidney deficiency type of chronic fatigue syndrome. China Pharmacy, 2008, 19(18):1416-1418.
5. Jean Carper.Magical Food.Beijing: Xinhua Publishing
Dou GX. Diet Guide, 1981, Jiangsu Sci and Tech Publishing.

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Responsible Party: Access Business Group
ClinicalTrials.gov Identifier: NCT02807649     History of Changes
Other Study ID Numbers: 13-SC-4-STL-002
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Syndrome
Fatigue
Mental Fatigue
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Behavioral Symptoms