InflammationPhase 1NCT00817752
Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation
A Phase 1 study testing Ashwagandha in people with Inflammation and Cancer, run by National University of Natural Medicine at 1 site in United States.
Trial summary
Ayurvedic medicine has been practiced in for more than 2,500 years. Ashwagandha is one of the most widely utilized herbs in the system. It is thought to affect the endocrine, immune, nervous, and cardiopulmonary systems. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Cancer, Autoimmune Diseases
- What is being tested?
- Ashwagandha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Feb 2008
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults, not pregnant
Who cannot join
- Fear or aversion to needles or blood draws.
- Recent infection or immunocompromised.
- Allergy to cow's milk.
- Known herb allergies.
- Aversions or medical contraindications to alcohol.
- Medication contra-indications, such as: benzodiazepines, CNS depressants,immunosuppressants and thyroid hormone and supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Ayurvedic medicine has been practiced in for more than 2,500 years. Ashwagandha is one of the most widely utilized herbs in the system. It is thought to affect the endocrine, immune, nervous, and cardiopulmonary systems. This study is designed as a preliminary investigation of the effects of Ashwagandha on stress, inflammation, and immune modulation. Participants will take the liquid extract in cow's milk twice a day for five days. The results of initial, one-day, and final blood draws will be compared to determine participant's beginning and ending levels of cortisol, inflammatory cytokines, and immune-cell activation (CD4 T-cells, CD8 T-cells, B cells and natural killer cells). Measurements will be completed using flow cytometry and ELISA assay. The purpose of this study is to determine which effects of Ashwagandha are most suitable for further investigation.
Read the detailed description
Due to the increased use of alternative medicine, supplements and herbs are consumed more frequently in the treatment of common ailments. This pilot study investigates the immune, anti-inflammatory and anti-stress effects of Ashwagandha in human subjects.
Liquid extract of the herb will be taken followed by milk; this mode of administration will be used as it approximates the traditional administration as well as making self administration easier for participants. Extract will be taken in 3 milliliter quantities 2 times per day, (morning and evening), for five days. Total dosage of 6 milliliters will approximate the higher end of the traditional daily dosage of 6 grams daily of powdered root.
Flow of visit:
25 participants will arrive at the research lab and after being consented, filling out health histories and two stress questionnaires, (POMS and STAI Self-Evaluation), average milk intake questionnaire. The 25 participants will receive blood draws. They will then be administered the herb extract, milk and instructions for taking them.
Subjects will return to the research institute after 24 hours for a second blood draw and then after 5 days for a final blood draw and two more stress questionnaires, (POMS and STAI Self-Evaluation).
Once the blood samples are drawn, they will be refrigerated and processed within 24 hours at the NCNM laboratory. Initially they will be centrifuged to separate the white from the red blood cells using Ficoll separating tubes. Then the white blood cells will be stained using CD69 marker (Cytokine Detection type 69) which assesses cell-surface phenotypic markers in combination with intracellular cytokines, measuring response to activation. It is especially effective for rare-event, antigen-specific events, such as the administration of a specific immune-stimulating herbal tincture. We will also stain with other similar florescent CD markers specific for CD4 T-cells, CD8 T-cells, B-cells, NK cells, and macrophages. These markers will be analyzed using a FACScan flow cytometer, which will count the number of cells that have been activated in each subtype of the immune cell and overall action. Blood will also be analyzed for cortisol levels and inflammatory cytokines, (IL-1, IL-6 and TNF-alpha) using the ELISA assay procedure.
- Conditions
- Inflammation, Cancer, Autoimmune Diseases
- Being tested
- Ashwagandha
- Keywords
- stress, inflammation, natural remedy, cytokines, interleukin, inflammatory conditions, auto-immune disorders
- Medical subject headings
- Inflammation, Neoplasms, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AshwagandhaDietary supplement
Participants consume 3mL of Ashwagandha for 5 days. Blood work/immune cells (CD4 T-cells, CD8 T-cells, B-cells, NK cells, macrophages, IL-1, IL-6 and TNF-alpha) and psychological assessments (POMS and STAI Self-Evaluation) given at specified time intervals.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Receives Ashwagandha herb. Receives: Dietary Supplement: Ashwagandha |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study will be to measure immune cell activation, inflammatory cytokines and cortisol levels after administration of the herb.
Measured: 24 hours and again at 5 days
Secondary outcomes (1)
The secondary endpoint of this study will be to measure and correlate stress levels to the use of the herb.
Measured: 24 hours and again at 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startMay 2007
- Primary completionJan 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Helfgott Research Institute
- Investigators
- Heather Zwickey, PhD, Principal investigator, Helfgott Research Institute at NCNM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817752
- Sponsor's protocol ID
- 02202007A
- Status last verified
- Jan 2009
- First submitted
- 2 Jan 2009
- Last updated
- 18 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation
- ClinicalTrials.gov ID
- NCT00817752
- Acronym / sponsor ID
- 02202007A
- Conditions
- Inflammation, Cancer, Autoimmune Diseases
- Keywords
- stress, inflammation, natural remedy, cytokines, interleukin, inflammatory conditions, auto-immune disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- Helfgott Research Institute
- Study start
- May 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 6 Jan 2009 (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.
Ayurvedic medicine has been practiced in for more than 2,500 years. Ashwagandha is one of the most widely utilized herbs in the system. It is thought to affect the endocrine, immune, nervous, and cardiopulmonary systems. This study is designed as a preliminary investigation of the effects of Ashwagandha on stress, inflammation, and immune modulation. Participants will take the liquid extract in cow's milk twice a day for five days. The results of initial, one-day, and final blood draws will be compared to determine participant's beginning and ending levels of cortisol, inflammatory cytokines, and immune-cell activation (CD4 T-cells, CD8 T-cells, B cells and natural killer cells). Measurements will be completed using flow cytometry and ELISA assay. The purpose of this study is to determine which effects of Ashwagandha are most suitable for further investigation.
Detailed description
Due to the increased use of alternative medicine, supplements and herbs are consumed more frequently in the treatment of common ailments. This pilot study investigates the immune, anti-inflammatory and anti-stress effects of Ashwagandha in human subjects.
Liquid extract of the herb will be taken followed by milk; this mode of administration will be used as it approximates the traditional administration as well as making self administration easier for participants. Extract will be taken in 3 milliliter quantities 2 times per day, (morning and evening), for five days. Total dosage of 6 milliliters will approximate the higher end of the traditional daily dosage of 6 grams daily of powdered root.
Flow of visit:
25 participants will arrive at the research lab and after being consented, filling out health histories and two stress questionnaires, (POMS and STAI Self-Evaluation), average milk intake questionnaire. The 25 participants will receive blood draws. They will then be administered the herb extract, milk and instructions for taking them.
Subjects will return to the research institute after 24 hours for a second blood draw and then after 5 days for a final blood draw and two more stress questionnaires, (POMS and STAI Self-Evaluation).
Once the blood samples are drawn, they will be refrigerated and processed within 24 hours at the NCNM laboratory. Initially they will be centrifuged to separate the white from the red blood cells using Ficoll separating tubes. Then the white blood cells will be stained using CD69 marker (Cytokine Detection type 69) which assesses cell-surface phenotypic markers in combination with intracellular cytokines, measuring response to activation. It is especially effective for rare-event, antigen-specific events, such as the administration of a specific immune-stimulating herbal tincture. We will also stain with other similar florescent CD markers specific for CD4 T-cells, CD8 T-cells, B-cells, NK cells, and macrophages. These markers will be analyzed using a FACScan flow cytometer, which will count the number of cells that have been activated in each subtype of the immune cell and overall action. Blood will also be analyzed for cortisol levels and inflammatory cytokines, (IL-1, IL-6 and TNF-alpha) using the ELISA assay procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: AshwagandhaReceives Ashwagandha herb. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults, not pregnant
Key exclusion criteria (6 listed)
- Fear or aversion to needles or blood draws.
- Recent infection or immunocompromised.
- Allergy to cow's milk.
- Known herb allergies.
- Aversions or medical contraindications to alcohol.
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 |
|---|---|---|
| AshwagandhaParticipants consume 3mL of Ashwagandha for 5 days. Blood work/immune cells (CD4 T-cells, CD8 T-cells, B-cells, NK cells, macrophages, IL-1, IL-6 and TNF-alpha) and psychological assessments (POMS and STAI Self-Evaluation) given at specified time intervals. | Dietary supplement | 1 |
Primary outcome
The primary endpoint of this study will be to measure immune cell activation, inflammatory cytokines and cortisol levels after administration of the herb.
Time frame: 24 hours and again at 5 days
1 secondary outcome
The secondary endpoint of this study will be to measure and correlate stress levels to the use of the herb.
Time frame: 24 hours and again at 5 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 18 Mar 2010.
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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.
Heather Zwickey, PhD principal investigator
Helfgott Research Institute at NCNM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ashwagandha in people with Inflammation and Cancer, run by National University of Natural Medicine at 1 site in United States.
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 6 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 18 Mar 2010. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary endpoint of this study will be to measure immune cell activation, inflammatory cytokines and cortisol levels after administration of the herb. (time frame: 24 hours and again at 5 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 18 Mar 2010.