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Effect of Ginko and Cistanche Against Fatigue Symptoms (GkoCist)

Primary Purpose

Mental Fatigue, Fatigue, Chronic Fatigue Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental: Nutrilite® Low dose
Experimental: Nutrilite® High dose
Placebo Comparator: Placebo
Sponsored by
Access Business Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Fatigue

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Placebo

    Low dose

    High dose

    Arm Description

    Placebo: Methyl cellulose and dextrose

    This blend contains Ginko at 120 mg/day and Cistanche at 300 mg/day

    This blend contains Ginko at 180 mg/day and Cistanche at 450 mg/day

    Outcomes

    Primary Outcome Measures

    Net change in the score of World Health Organization Quality of Life survey before and after intervention

    Secondary Outcome Measures

    Net change in the score of Chalder fatigue scale survey before and after intervention
    Net change in the score of Chalder fatigue self assessment survey before and after intervention

    Full Information

    First Posted
    January 7, 2016
    Last Updated
    June 20, 2016
    Sponsor
    Access Business Group
    Collaborators
    Sinphar Pharmaceutical Co., Ltd, Sprim Advanced Life Sciences, Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02807649
    Brief Title
    Effect of Ginko and Cistanche Against Fatigue Symptoms
    Acronym
    GkoCist
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Access Business Group
    Collaborators
    Sinphar Pharmaceutical Co., Ltd, Sprim Advanced Life Sciences, Fudan University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Fatigue, Fatigue, Chronic Fatigue Syndrome

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    159 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo: Methyl cellulose and dextrose
    Arm Title
    Low dose
    Arm Type
    Active Comparator
    Arm Description
    This blend contains Ginko at 120 mg/day and Cistanche at 300 mg/day
    Arm Title
    High dose
    Arm Type
    Active Comparator
    Arm Description
    This blend contains Ginko at 180 mg/day and Cistanche at 450 mg/day
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Experimental: Nutrilite® Low dose
    Intervention Description
    Two tablets consume daily with meal.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Experimental: Nutrilite® High dose
    Intervention Description
    Two tablets consume daily with meal.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo Comparator: Placebo
    Intervention Description
    Two tablets consume daily with meal.
    Primary Outcome Measure Information:
    Title
    Net change in the score of World Health Organization Quality of Life survey before and after intervention
    Time Frame
    60 days
    Secondary Outcome Measure Information:
    Title
    Net change in the score of Chalder fatigue scale survey before and after intervention
    Time Frame
    60 days
    Title
    Net change in the score of Chalder fatigue self assessment survey before and after intervention
    Time Frame
    60 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shuguang Li, PhD
    Organizational Affiliation
    Fudan University, Department of Nutrition and Food Hygiene
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    Citation
    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
    Results Reference
    background
    Citation
    2. Zhang J. Clinical study on behavior intervention in chronic fatigue syndrome. Liaoning Journal of Traditional Chinese Medicine, 2009, 36(8):1338-1340.
    Results Reference
    background
    PubMed Identifier
    7978722
    Citation
    Fukuda K, Straus SE, Hickie I, Sharpe MC, Dobbins JG, Komaroff A. The chronic fatigue syndrome: a comprehensive approach to its definition and study. International Chronic Fatigue Syndrome Study Group. Ann Intern Med. 1994 Dec 15;121(12):953-9. doi: 10.7326/0003-4819-121-12-199412150-00009.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    5. Jean Carper.Magical Food.Beijing: Xinhua Publishing
    Results Reference
    background
    Citation
    Dou GX. Diet Guide, 1981, Jiangsu Sci and Tech Publishing.
    Results Reference
    background
    PubMed Identifier
    34901100
    Citation
    Kan J, Cheng J, Hu C, Chen L, Liu S, Venzon D, Murray M, Li S, Du J. A Botanical Product Containing Cistanche and Ginkgo Extracts Potentially Improves Chronic Fatigue Syndrome Symptoms in Adults: A Randomized, Double-Blind, and Placebo-Controlled Study. Front Nutr. 2021 Nov 26;8:658630. doi: 10.3389/fnut.2021.658630. eCollection 2021.
    Results Reference
    derived

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