Effect of Ginko and Cistanche Against Fatigue Symptoms

NCT02807649 | Completed DMC

• 1 other identifier: 13-SC-4-STL-002
• Study Type: interventional
• Target: 159
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mental Fatigue; Fatigue; Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

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

  60 days

Secondary Outcomes (2)

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

  60 days

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

  60 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo: Methyl cellulose and dextrose

Dietary Supplement: Placebo Comparator: Placebo

Low dose

ACTIVE COMPARATOR

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

Dietary Supplement: Experimental: Nutrilite® Low dose

High dose

ACTIVE COMPARATOR

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

Dietary Supplement: Experimental: Nutrilite® High dose

Interventions

Experimental: Nutrilite® Low dose DIETARY_SUPPLEMENT

Two tablets consume daily with meal.

Low dose

Experimental: Nutrilite® High dose DIETARY_SUPPLEMENT

Two tablets consume daily with meal.

High dose

Placebo Comparator: Placebo DIETARY_SUPPLEMENT

Two tablets consume daily with meal.

Placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Access Business Group: lead
• Sinphar Pharmaceutical Co., Ltd: collaborator
• Sprim Advanced Life Sciences: collaborator
• Fudan University: collaborator

Related Publications (7)

• 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

  BACKGROUND

• 2. Zhang J. Clinical study on behavior intervention in chronic fatigue syndrome. Liaoning Journal of Traditional Chinese Medicine, 2009, 36(8):1338-1340.

  BACKGROUND

• 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.

  PMID: 7978722 BACKGROUND

• 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.

  BACKGROUND

• 5. Jean Carper.Magical Food.Beijing: Xinhua Publishing

  BACKGROUND

• Dou GX. Diet Guide, 1981, Jiangsu Sci and Tech Publishing.

  BACKGROUND

• 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.

  PMID: 34901100 DERIVED

MeSH Terms

Conditions

Mental Fatigue; Fatigue; Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Shuguang Li, PhD

  Fudan University, Department of Nutrition and Food Hygiene

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: June 21, 2016
• Study Start: May 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 21, 2016

Record last verified: 2016-06