Physical FitnessNCT01718548
The Effects of Cordyceps Sinensis and Lingzhi on Cardiovascular Fitness and Cognitive Function
A study testing Cordyceps Sinensis (CS) and Lingzhi and Tea and Flour in people with Physical Fitness and Executive Function, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Cordyceps Sinensis (CS) and Lingzhi extracts have been used in Chinese Medicine for many years for treatment of a variety of conditions. The aim of this study is to evaluate the effects of oral ingestion of CS and Lingzhi extracts of a period of 28 days on cardiopulmonary fitness and cognitive functioning in young… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness, Executive Function
- What is being tested?
- Cordyceps Sinensis (CS) and Lingzhi and Tea and Flour
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Dec 2013
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physical education students
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
Israel1 site
Wingate Institute
Netanya
Sharon Tsuk, PhD, 09-8639235, sharontsuk1@gmail.com
Sharon Tsuk, PhD
About this study
Cordyceps Sinensis (CS) and Lingzhi extracts have been used in Chinese Medicine for many years for treatment of a variety of conditions. The aim of this study is to evaluate the effects of oral ingestion of CS and Lingzhi extracts of a period of 28 days on cardiopulmonary fitness and cognitive functioning in young, healthy physical education students.
- Conditions
- Physical Fitness, Executive Function
- Being tested
- Cordyceps Sinensis (CS) and Lingzhi, Tea and Flour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cordyceps Sinensis (CS) and LingzhiDietary supplement
Tea and FlourDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CS and Lingzhi | Active comparator | CS liquid (each dosage is a bottle of liquid containing 30 ml: comprising 75% of CS, 6% Lingzhi, 6% shitake, 5% bamboo shoot, 2% honey, 0.1% potassium sorbet and 5.9% pure water) and Lingzhi capsule (each capsule contains 620mg of: 52.42% Lingzhi, 28.23% CS, and 19.35% soy gel ) ; one quarter bottle of CS to be ingested twice a day, and the Lingzhi capsule to be taken once a day, both for a period of 28 days. Receives: Dietary Supplement: Cordyceps Sinensis (CS) and Lingzhi |
| Placebo | Placebo comparator | Liquid tea ingested twice a day and flour-filled capsules ingested once a day over a period of 28 days Receives: Dietary Supplement: Tea and Flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Cardiopulmonary Fitness after Ingestion of CS and Lingzhi Extracts
Before and after 28-day ingestion of CS and Lingzhi extracts, subjects will undergo a graded exercise test on a treadmill and results will be compared.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FitnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718548
- Sponsor's protocol ID
- 0062-12-HYMC
- Status last verified
- Oct 2012
- First submitted
- 29 Oct 2012
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cordyceps Sinensis and Lingzhi on Cardiovascular Fitness and Cognitive Function
- ClinicalTrials.gov ID
- NCT01718548
- Acronym / sponsor ID
- 0062-12-HYMC
- Conditions
- Physical Fitness, Executive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 31 Oct 2012 (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.
Cordyceps Sinensis (CS) and Lingzhi extracts have been used in Chinese Medicine for many years for treatment of a variety of conditions. The aim of this study is to evaluate the effects of oral ingestion of CS and Lingzhi extracts of a period of 28 days on cardiopulmonary fitness and cognitive functioning in young, healthy physical education students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CS and Lingzhi | Active comparator | Dietary Supplement: Cordyceps Sinensis (CS) and LingzhiCS liquid (each dosage is a bottle of liquid containing 30 ml: comprising 75% of CS, 6% Lingzhi, 6% shitake, 5% bamboo shoot, 2% honey, 0.1% potassium sorbet and 5.9% pure water) and Lingzhi capsule (each capsule contains 620mg of: 52.42% Lingzhi, 28.23% CS, and 19.35% soy gel ) ; one quarter bottle of CS to be ingested twice a day, and the Lingzhi capsule to be taken once a day, both for a period of 28 days. |
| Placebo | Placebo comparator | Dietary Supplement: Tea and FlourLiquid tea ingested twice a day and flour-filled capsules ingested once a day over a period of 28 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physical education students
Key exclusion criteria (1 listed)
- All others
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 |
|---|---|---|
| Cordyceps Sinensis (CS) and Lingzhi | Dietary supplement | CS and Lingzhi |
| Tea and FlourPlacebo | Dietary supplement | Placebo |
Primary outcome
Improvement in Cardiopulmonary Fitness after Ingestion of CS and Lingzhi Extracts
Time frame: 28 days
Before and after 28-day ingestion of CS and Lingzhi extracts, subjects will undergo a graded exercise test on a treadmill and results will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cordyceps Sinensis (CS) and Lingzhi and Tea and Flour in people with Physical Fitness and Executive Function, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Cardiopulmonary Fitness after Ingestion of CS and Lingzhi Extracts (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2012.