Status:
COMPLETED
Clinical Trial of Tahitian Noni Juice Safety
Lead Sponsor:
Tahitian Noni International, Inc.
Collaborating Sponsors:
TNO-BIBRA
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
For 28 days, healthy volunteers will consume one of four daily quantities of Tahitian Noni juice: 0 mL (placebo), 30 mL, 300 mL, or 750 mL. Hematology, biochemistry, urinalysis, vital signs, and adver...
Eligibility Criteria
Inclusion
- Subjects were male or female, aged between 18 and 65 years inclusive.
- Subjects had a BMI of between 19 and 30 kg/m2 inclusive.
- Prior to study commencement, subjects signed and dated a witnessed informed consent form.
- Subjects had a satisfactory documented medical history during the 21 days prior to study commencement.
- Normal blood biochemistry, haematology, urinalysis and ECG were confirmed during the 21 days prior to study commencement.
- Subjects had negative virology profile (hepatitis B surface-antigen and hepatitis C virus antibody) confirmed during the 21 days prior to study commencement.
- Females of child-bearing potential had a documented negative urine pregnancy test and were not lactating or trying to become pregnant during the course of the study. They were using an adequate method of contraception. A female of non-childbearing potential was defined as one who had been post-menopausal for at least 12 months, had been surgically sterilised, or had a hysterectomy at least 3 months prior to study start.
Exclusion
- Subjects with any evidence or history of clinically significant hepatic or renal disorder, cardiovascular, respiratory, metabolic, immunological, neurological, psychiatric or gastrointestinal disease.
- Subjects with a history of asthma or allergic skin rash or other relevant allergic reaction.
- Subjects with known hypersensitivity or intolerance to drugs in general.
- Subjects with a history of alcohol abuse (more than 28 units per week for males and more than 21 units for females).
- Subjects who tested positive for hepatitis B surface-antigen and hepatitis C virus antibody.
- Subjects who had been on a course of prescribed drug treatment within 28 days of the study start that had not been approved by the Principal Investigator.
- Subjects who had taken any over the counter (OTC) drugs, vitamins, herbal remedies or used topically applied preparations within one week of study start unless the Principal Investigator had given approval.
- Subjects who smoked more than five cigarettes daily.
- Subjects who participated in a clinical trial or donated more than 500 ml of blood in the three months prior to study commencement.
- Female subjects who were pregnant, lactating or trying to become pregnant during the course of the study.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01424748
Start Date
April 1 2003
End Date
June 1 2003
Last Update
August 29 2011
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