Effect of Herbal Products on Platelet Function and Clotting

NCT02008981 | Completed Phase 3

• 1 other identifier: TCM platelet function
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Platelet Function Test

Outcome Measures

Primary Outcomes (1)

• 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

  3 weeks

Study Arms (3)

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.

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.

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.

Drug: Siwu Tang; Drug: Aspirin

Interventions

Curcuma longa DRUG

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.

Curcuma longa

Angelica sinensis DRUG

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.

Angelica sinensis

Siwu Tang DRUG

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.

Siwu Tang

Aspirin DRUG

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.

Angelica sinensis; Curcuma longa; Siwu Tang

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Singapore General Hospital: lead
• Singhealth Foundation: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

Location

MeSH Terms

Interventions

turmeric extract; angelicae sinensis extract; Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Yeh-Ching Linn, MBBS, MRCP

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2013
• First Posted: December 11, 2013
• Study Start: December 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

SG (1)