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Summary
A double-blinded,
randomized parallel
group pilot study was
conducted showing the
effects of Apocynum
venetum Leaf Extract on
symptoms of depression
in individuals with mild
depression. The study
began
in August 2005 and ended
in May 2006. Once the
last subject was
recruited, final results
were compiled.
This trial revealed that
Apocynum venetum Leaf
Extract may be
considered a beneficial
alternative
for those who experience
mild depression and
suffer from anxiety.
Study Participants and
Protocol
In order to be included
as a participant in the
trial, several criteria
had to be met. Both men
and women,
between the ages of
18-65 years, were
eligible. At the initial
screening visit, a
signed consent form was
obtained. Mild
depression was
determined through the
use of the Hamilton
Depression Rating Scale
(HAM-D) — a multiple
choice questionnaire
that rates the severity
of symptoms observed in
depression such as low
mood, insomnia,
agitation, anxiety, and
weight loss. Originally
developed in 1960, it is
one of the most widely
used and respected
clinical scales for
rating the severity of
depression in medical
research. Those who
fulfilled the inclusion
criteria for mild to
moderate depression (a
total score in the range
of 14-20 on the HAM-D
17-item version), but
with a maximum score of
1 on HAM-D Question 3
(regarding suicidality)
were asked to undergo a
physical examination by
the study physician.
Potential subjects were
required to be deemed
healthy, which was
determined by a physical
examination and blood
chemistry panels. The
physical examination
included blood pressure
and anthropometric
measurements as well as
health tests {glucose,
urea, creatinine,
sodium, potassium,
chloride, TSH, bilirubin,
Alk Phos, AST, SGOT,
SGPT, total protein, CBC,
hemoglobin, RBC, WBC,
and platelets}. Body
Mass Index (BMI) — a
measure of body fat
based on height and
weight — had to be in
the range of 18-35 kg/m2
to be considered.Upon
confirmation that the
individual was mildly
depressed, but healthy,
and eligible according
to blood tests, an
appointment was arranged
for the study to
commence.
The exclusion criteria
included:
• Non-compliance
• Anticipated problems
with product
consumption
• Moderately severe
co-morbid disease
(including cardiac,
pulmonary, renal,
hepatic, active cancer,
diabetes,
hypertension,
immunological
and neurological
disease)
• Consumption of
nutritional, herbal or
prescription product
containing
St. John’s wort,
hypericin, hyperforin,
hyperoside or
isoquercitrin within
the past 30 days
• High alcohol intake
{more than two
drinks per day}
• Pregnant or
breastfeeding
• Use of antidepressant
prescription
medication
• Use of herbal products
within one week
before the study
Sixty-six subjects were
assessed for
eligibility; 47 were
enrolled in the study.
At baseline (Day 0),
eligible subjects were
randomly divided, using
randomization tables,
into two groups — the
Apocynum venetum Leaf
Extract group was
assigned 27 subjects,
and 20 were in the
placebo group. Subjects
were blindly designated
to receive an 8-week
supply of either
Apocynum venetum Leaf
Extract or placebo.
Participants were
instructed to take two
tablets per day.
Subjects were given
forms to report weekly
adverse effects, blood
pressure was measured,
and blood samples were
drawn to determine blood
neurotransmitters. After
4 weeks had elapsed,
HAM-D scores and blood
pressure were
determined. At the end
of the 8-week study
period, completed
symptom/side effect
forms and unused study
product were collected.
A second blood sample
was drawn from study
participants for
determination of blood
neurotransmitters. HAM-D
scores and blood
pressure were also
measured.
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