Mental FatigueGkoCistNCT02807649
Effect of Ginko and Cistanche Against Fatigue Symptoms
A study testing Experimental: Nutrilite® Low dose and Experimental: Nutrilite® High dose in people with Mental Fatigue and Fatigue, run by Access Business Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Fatigue, Fatigue, Chronic Fatigue Syndrome
- What is being tested?
- Experimental: Nutrilite® Low dose and Experimental: Nutrilite® High dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Mental Fatigue, Fatigue, Chronic Fatigue Syndrome
- Being tested
- Experimental: Nutrilite® Low dose, Experimental: Nutrilite® High dose, Placebo Comparator: Placebo
- Medical subject headings
- Mental Fatigue, Fatigue, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Nutrilite® Low doseDietary supplement
Two tablets consume daily with meal.
Experimental: Nutrilite® High doseDietary supplement
Two tablets consume daily with meal.
Placebo Comparator: PlaceboDietary supplement
Two tablets consume daily with meal.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo: Methyl cellulose and dextrose Receives: Dietary Supplement: Placebo Comparator: Placebo |
| Low dose | Active comparator | This blend contains Ginko at 120 mg/day and Cistanche at 300 mg/day Receives: Dietary Supplement: Experimental: Nutrilite® Low dose |
| High dose | Active comparator | This blend contains Ginko at 180 mg/day and Cistanche at 450 mg/day Receives: Dietary Supplement: Experimental: Nutrilite® High dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net change in the score of World Health Organization Quality of Life survey before and after intervention
Measured: 60 days
Secondary outcomes (2)
Net change in the score of Chalder fatigue scale survey before and after intervention
Measured: 60 days
Net change in the score of Chalder fatigue self assessment survey before and after intervention
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mental FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access Business Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sinphar Pharmaceutical Co., Ltd, Sprim Advanced Life Sciences, Fudan University
- Responsible party
- Sponsor
- Investigators
- Shuguang Li, PhD, Principal investigator, Fudan University, Department of Nutrition and Food Hygiene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807649
- Sponsor's protocol ID
- 13-SC-4-STL-002
- Acronym
- GkoCist
- Status last verified
- Jun 2016
- First submitted
- 7 Jan 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
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.
PubMed 79787224. 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.
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.
PubMed 34901100
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02807649
- Acronym / sponsor ID
- GkoCist / 13-SC-4-STL-002
- Conditions
- Mental Fatigue, Fatigue, Chronic Fatigue Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Access Business GroupIndustry (pharma, biotech, devices)
- Collaborators
- Sinphar Pharmaceutical Co., Ltd, Sprim Advanced Life Sciences, Fudan University
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo Comparator: PlaceboPlacebo: Methyl cellulose and dextrose |
| Low dose | Active comparator | Dietary Supplement: Experimental: Nutrilite® Low doseThis blend contains Ginko at 120 mg/day and Cistanche at 300 mg/day |
| High dose | Active comparator | Dietary Supplement: Experimental: Nutrilite® High doseThis blend contains Ginko at 180 mg/day and Cistanche at 450 mg/day |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Nutrilite® Low doseTwo tablets consume daily with meal. | Dietary supplement | Low dose |
| Experimental: Nutrilite® High doseTwo tablets consume daily with meal. | Dietary supplement | High dose |
| Placebo Comparator: PlaceboTwo tablets consume daily with meal. | Dietary supplement | Placebo |
Primary outcome
Net change in the score of World Health Organization Quality of Life survey before and after intervention
Time frame: 60 days
2 secondary outcomes
Net change in the score of Chalder fatigue scale survey before and after intervention
Time frame: 60 days
Net change in the score of Chalder fatigue self assessment survey before and after intervention
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Background1. 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
- Background2. Zhang J. Clinical study on behavior intervention in chronic fatigue syndrome. Liaoning Journal of Traditional Chinese Medicine, 2009, 36(8):1338-1340.
- Background: PubMed 7978722Fukuda 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.
- Background4. 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.
- Background5. Jean Carper.Magical Food.Beijing: Xinhua Publishing
- BackgroundDou GX. Diet Guide, 1981, Jiangsu Sci and Tech Publishing.
- Derived from this study: PubMed 34901100Kan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuguang Li, PhD principal investigator
Fudan University, Department of Nutrition and Food Hygiene
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Nutrilite® Low dose and Experimental: Nutrilite® High dose in people with Mental Fatigue and Fatigue, run by Access Business Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net change in the score of World Health Organization Quality of Life survey before and after intervention (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02807649, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.