Platelet Function TestPhase 3NCT02008981
Effect of Herbal Products on Platelet Function and Clotting
A Phase 3 study testing Curcuma longa, Angelica sinensis and Siwu Tang in people with Platelet Function Test, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
This is a research study on the effect of some commonly used "blood activating" herbal products on platelet function and coagulation profile, ie whether it causes an increase in bleeding tendency, either used alone or in combination with Aspirin which is a commonly used anti-platelet drug. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet Function Test
- What is being tested?
- Curcuma longa, Angelica sinensis and Siwu Tang
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2013to Apr 2014
- Phase
- Phase 3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females between the ages of 18 and 70 years.
- Healthy by medical history and physical exam.
- Laboratory values within established guidelines for participation in clinical studies: AST less than or equal to 2 times the ULN; SCr less than or equal to ULN; FBC showing normal Hb; WBC and platelet count; normal aPTT/PT
- Negative urine pregnancy test for females of child-bearing potential.
- Females of child-bearing potential who are able and willing to practice abstinence or use non-hormonal effective methods of birth control during the study, such as condoms or diaphragms.
Who cannot join
- Concomitant therapy (chronic or intermittent) with herbal drugs, aspirin, any other anti-platelet agents, non-steroidal anti-inflammatory medications or warfarin from 14 days prior to study participation and throughout the study period
- Inability to obtain venous access for blood sample collection.
- The presence of any of the following significant medical conditions:
- Diabetes mellitus poorly controlled or requiring insulin
- Hypertension poorly controlled
- Cardiac disease : heart failure, arrhythmia poorly controlled
Show all 17Show fewer
- Renal disease,
- Hepatic impairment
- Bleeding disorders including thrombocytopenia and coagulopathy, either congenital or acquired
- Peptic ulcer disease
- Psychiatric illnesses that may interfere with the subject's ability to participate in the study, or any other condition that may interfere with the interpretation of the study results or not be in the best interest of the subject in the opinion of the investigators.
- Plans for elective surgery during the investigation or within 2 weeks following completion of the study.
- Positive urine pregnancy test or breastfeeding female.
- The presence of persistent diarrhea or malabsorption that would interfere with the subject's ability to absorb drugs.
- Drug or alcohol abuse that may impair safety or adherence (more than 3 alcoholic drinks per day, on a daily basis).
- History of intolerance or allergic reaction to aspirin or any NSAIDS
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Crossover Study on the Effect of Commonly Used Herbal Products on Platelet Function and Coagulation Profile of Healthy Volunteers
This is a research study on the effect of some commonly used "blood activating" herbal products on platelet function and coagulation profile, ie whether it causes an increase in bleeding tendency, either used alone or in combination with Aspirin which is a commonly used anti-platelet drug.
Read the detailed description
This study is being conducted because there has not been any proper studies to provide evidence that these commonly used "blood activating" herbal preparations can in fact affect blood clotting by interfering with platelet function or clotting mechanism and potentiate the antiplatelet activity of Aspirin. These are assumptions based on TCM theory, laboratory experiments and animal studies but have led to the general statement in medical literature that these herbs increases bleeding risk in patients taking Aspirin or any other anti-platelet drugs. This has resulted in advice that these herbal products should not be taken by patients on Aspirin, which is a common drug taken by many patients. We hope to prove or disprove this theoretical concern by measurement of platelet and clotting function in healthy volunteers before and after taking the herbal product, alone and in combination with Aspirin. This will help to answer the question of whether it is safe for patients to take these common "blood -activating " herbs alone or together with Aspirin.
Healthy volunteers will be consecutively enrolled into 3 arms, each studying one herbal product for 25 volunteers. The design involves taking all 3 of the following combinations: aspirin + placebo, herb + placebo, aspirin + herb, each for a 3-week period, in a randomized order, with 2 weeks of wash-out in between each 3-week period. Platelet function and coagulation profile will be assayed
- Conditions
- Platelet Function Test
- Being tested
- Curcuma longa, Angelica sinensis, Siwu Tang, Aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcuma longaDrug
Curcuma longa in capsule form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after.
Angelica sinensisDrug
Angelicae sinensis in capsule form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after.
Siwu TangDrug
TCM formulation "Siwu Tang" consisting of 4 herbs ( Ligustici chuangxiong, Angelicae sinensis, Rehmanniae praeparata and Paeoniae alba) in tablet form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after.
AspirinDrug
Aspirin (enteric-coated) at 100mg daily will be given one of the actual herb or placebo herb, each for a 3 week period. Clotting profile and platelet function test will be done before and after.
| Study group | Role | What they receive |
|---|---|---|
| Angelica sinensis | Active comparator | Angelica sinensis in capsule form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after. Receives: Drug: Angelica sinensis; Drug: Aspirin |
| Curcuma longa | Active comparator | Curcuma longa in capsule form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after. Receives: Drug: Curcuma longa; Drug: Aspirin |
| Siwu Tang | Active comparator | TCM formulation "Siwu Tang" consisting of 4 herbs ( Ligustici chuangxiong, Angelicae sinensis, Rehmanniae praeparata and Paeoniae alba) in tablet form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after. Receives: Drug: Siwu Tang; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet function test and coagulation profile
Platelet function test and coagulation profile ( aPTT/PT) will be done at baseline and after each phase of 3 weeks of Herb/aspirin or their placebo
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Function TestStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singhealth Foundation
- Responsible party
- Sponsor
- Investigators
- Yeh-Ching Linn, MBBS, MRCP, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008981
- Sponsor's protocol ID
- TCM platelet function
- Status last verified
- Nov 2015
- First submitted
- 8 Dec 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Crossover Study on the Effect of Commonly Used Herbal Products on Platelet Function and Coagulation Profile of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02008981
- Acronym / sponsor ID
- TCM platelet function
- Conditions
- Platelet Function Test
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Singhealth Foundation
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Dec 2013 (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.
This is a research study on the effect of some commonly used "blood activating" herbal products on platelet function and coagulation profile, ie whether it causes an increase in bleeding tendency, either used alone or in combination with Aspirin which is a commonly used anti-platelet drug.
Detailed description
This study is being conducted because there has not been any proper studies to provide evidence that these commonly used "blood activating" herbal preparations can in fact affect blood clotting by interfering with platelet function or clotting mechanism and potentiate the antiplatelet activity of Aspirin. These are assumptions based on TCM theory, laboratory experiments and animal studies but have led to the general statement in medical literature that these herbs increases bleeding risk in patients taking Aspirin or any other anti-platelet drugs. This has resulted in advice that these herbal products should not be taken by patients on Aspirin, which is a common drug taken by many patients. We hope to prove or disprove this theoretical concern by measurement of platelet and clotting function in healthy volunteers before and after taking the herbal product, alone and in combination with Aspirin. This will help to answer the question of whether it is safe for patients to take these common "blood -activating " herbs alone or together with Aspirin.
Healthy volunteers will be consecutively enrolled into 3 arms, each studying one herbal product for 25 volunteers. The design involves taking all 3 of the following combinations: aspirin + placebo, herb + placebo, aspirin + herb, each for a 3-week period, in a randomized order, with 2 weeks of wash-out in between each 3-week period. Platelet function and coagulation profile will be assayed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Angelica sinensis | Active comparator | Drug: Angelica sinensis, Drug: AspirinAngelica sinensis in capsule form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after. |
| Curcuma longa | Active comparator | Drug: Curcuma longa, Drug: AspirinCurcuma longa in capsule form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after. |
| Siwu Tang | Active comparator | Drug: Siwu Tang, Drug: AspirinTCM formulation "Siwu Tang" consisting of 4 herbs ( Ligustici chuangxiong, Angelicae sinensis, Rehmanniae praeparata and Paeoniae alba) in tablet form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females between the ages of 18 and 70 years.
- Healthy by medical history and physical exam.
- Laboratory values within established guidelines for participation in clinical studies: AST less than or equal to 2 times the ULN; SCr less than or equal to ULN; FBC showing normal Hb; WBC and platelet count; normal aPTT/PT
- Negative urine pregnancy test for females of child-bearing potential.
- Females of child-bearing potential who are able and willing to practice abstinence or use non-hormonal effective methods of birth control during the study, such as condoms or diaphragms.
Key exclusion criteria (17 listed)
- Concomitant therapy (chronic or intermittent) with herbal drugs, aspirin, any other anti-platelet agents, non-steroidal anti-inflammatory medications or warfarin from 14 days prior to study participation and throughout the study period
- Inability to obtain venous access for blood sample collection.
- The presence of any of the following significant medical conditions:
- Plans for elective surgery during the investigation or within 2 weeks following completion of the study.
- Positive urine pregnancy test or breastfeeding female.
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 |
|---|---|---|
| Curcuma longaCurcuma longa in capsule form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after. | Drug | Curcuma longa |
| Angelica sinensisAngelicae sinensis in capsule form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after. | Drug | Angelica sinensis |
| Siwu TangTCM formulation "Siwu Tang" consisting of 4 herbs ( Ligustici chuangxiong, Angelicae sinensis, Rehmanniae praeparata and Paeoniae alba) in tablet form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after. | Drug | Siwu Tang |
| AspirinAspirin (enteric-coated) at 100mg daily will be given one of the actual herb or placebo herb, each for a 3 week period. Clotting profile and platelet function test will be done before and after. | Drug | Angelica sinensis, Curcuma longa, Siwu Tang |
Primary outcome
platelet function test and coagulation profile
Time frame: 3 weeks
Platelet function test and coagulation profile ( aPTT/PT) will be done at baseline and after each phase of 3 weeks of Herb/aspirin or their placebo
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 20 Nov 2015.
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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.
Yeh-Ching Linn, MBBS, MRCP principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Curcuma longa, Angelica sinensis and Siwu Tang in people with Platelet Function Test, run by Singapore General Hospital at 1 site in Singapore.
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 5 inclusion and 17 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 20 Nov 2015. 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 Singapore. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
platelet function test and coagulation profile (time frame: 3 weeks). 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 20 Nov 2015.