Clinical trial: Clinical Trial of Tahitian Noni Juice Safety (NCT01424748)

Eligibility criteria:
Inclusion Criteria:

          -  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 Criteria:

          -  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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Entailment