Herbal Drugs: clinical

perspective
Dr. Bhavesh Nayak
Principal
Shree Swaminarayan Sanskar
Pharmacy College

Definition:

Herbal Drug /Herbal Medicine:

The WHO has defined traditional medicine
(including
herbal
drugs)
as
comprising
therapeutic practices that have been in
existence, often for hundred of years, before
the development and spread of modern
medicine and are still in use today.
Traditional medicine is the synthesis of
therapeutic
experience
of
generations
of
practicing physicians of indigenous system of
medicine. Traditional preparations comprise
medicinal plants, minerals and organic matter
etc.
Herbal drugs constitute only those traditional
medicines which primarily use medicinal plant
preparations for therapy.
The earliest recorded evidence of their use in
Indian, Chinese, Egyptian, Greek, Roman and
Syrian texts dates back to about 5000 years.

Classification of Herbal
Drugs
Organized drugs.
Unorganized drugs.
Also classified on the basis of Therapeutic
use, chemical constituents and indigenous
method of preparation
On the basis of Traditional system of
medicine
Phytopharmaceutical
Nutraceutical (Nutritionally or Medicinally
enhanced foods with health benefits)

Why Herbal medicine?

Herbal medicine are being used by about

80% of the world population primarily in
the developing countries for primary
health care. They have stood the test of
time for their safety, efficacy, cultural
acceptability and lesser side effect.
The chemical constituents present in
herbs are part of
physiological
functions of living flora and hence they
are
believed
to
have
better
compatibility with human body.

 Ancient literature also mentions herbal for

age related diseases namely memory loss,
osteoporosis, diabetic wounds, immune
and liver disorders for which no modern
medicine or only palliative therapy is
available.
Herbal drugs are made from renewable
resources of raw materials by ecofriendly
processes and will bring economic
prosperity to the population growing these
raw material.

 In rural areas, there are additional cultural

factors that encourage the use of botanicals,
such as the environment and culture, a
man earth relationship. People believe
that where an area gives rise to a particular
disease, it will also support plants that can
be used to cure it (Winslow and Kroll, 1998).
In India vast sections of the rural population
have no assess to modern medicine (Mudur,
1997). Hundred of primary health centers
which are intended to serve rural areas, lack
staffs, diagnostic facilities, and adequate
supplies of drugs. The rural population is
heavily dependent on traditional medical
systems (Mudur, 1995).

 Natural (plant) products are perceived

to be healthier than manufactured
medicine (Gesler, 1992).
Report
of
adverse
effect
of
conventional medications are found in
the nonprofessional reports at a much
higher rate than reports of herbal
toxicities

Status of Herbal Medicine

in
India
has a rich tradition of herbal medicine as
India
evident from Ayurveda, which could not have

flourished for two thousand years without any

scientific basis.
Ayurveda which literally means knowledge (Veda)
of life (Ayur) had its beginning in Atharvaveda
(Circa 1500-1000 BC).
Charak Samhita and Sushruta Samhita are the
two most famous treatises of Ayurveda several
other were compiled over the centuries such as
Bela Samhita, Kashyap Samhita, Agnivesh Tantra,
Vagbhatas Ashtang hridaya (600), Madhava
Nidan(700 AD).
Vegetable products dominated Indian Meteria
Medica which made extensive use of bark, leaves,
flower, fruit, root, tubers and juices.

 Charak, Sushruta and Vagbhata described

700 herbal drugs with their properties and
clinical effects.
Based on clinical effects 50 categories of
drug have been described
such as appetizers, digestive stimulant,
laxatives, anti-diarrhea, anti-haemorrhoid,
anti-emetic, anti-pyretic, anti-inflammatory,
anti-pruritic, anti-asthmatic, antiepileptic,
anti-helminthic, haemoptietic, haemostatic,
analgesis, sedative, promoter of life
(Rasyana),
promoter
of
strength,
complexion, voice, semen and sperm,
breast milk secretion, fracture and wound
healing, destroyer of kidney stones etc
(Lele, 1999).

Ayurvedic drugs which are understood in

terms
of
todays molecular
pharmacology:
Sarpagangha
(Rauwolfia serpentina)
Reserpine uniquely

prevent pre-synaptc neuronal vesicular uptake of biogenic

amines (dopamine, serotonin and nor-epinephrine).
Mainmool (Coleus forskoli Briq) Forskolin directly
stimulates adenylate cyclase and cyclic AMP, with
inotropic and Lusitropic effect on heart muscle.
Sallaki (Boswellia serrata) Boswelic acid inhibits 5lipooxygenase and leukotreine B4 resulting in antiinflammatory and anti-complement effect.
Shirish
(Albizzia
lebek)
prevents
mast
cell
degranulation, similar to sodium cromoglycate.
Aturagupta (Mucona pruriens) contains L-DOPA
Ashwagandha (Withania somnifera) GABA-A receptor
agonist.
Katuka (Picrorhiza kurua) anti-oxidant action equal to
a tocopherol, effect on glutathion metabolism in liver
and brain

 Drugs like Asparagus racemousus, Tinospora

codifolia and Ocimum sanctum antagonise
the effect of stress (Dhuri et al., 2000).
Emblica officinalis L., Curcuma longaL.,
Mangifera indica L., Momordica charantia L.,
Santalum album L., Swertia chirata Buch-Ham,
Winthania somnifera (L.) have well defined
antioxidant properties and justify their use
in traditional medicine in the past as well as the
present.
Use of the herbal medicine in jaundice,
presumably viral hepatitis, has been known in
India science the Vedic times.
About 170 phyto-constituents isolated from 110
plants have been reported so far to possess
liver protective activities. It is estimated that
about 6000 commercial herbal formulations are
sold world over as hepatoproctective drugs.

WHAT CONSTITUTES AN HERBAL

CLINICAL
RESEARCH
Doctrine of Signatures:
The Doctrine of Signatures- the idea that the
shape, colour and other features of a plant may
suggest its medicinal purpose.
For example, they noted the red and puffy
bladder-shaped covering of Physalis alkekengi
fruit, and experimented with various parts of the
plant in treating kidney and bladder disorders.
walnuts were good for curing head conditions
because "they have the perfect signatures of the
head".
the general impression today is that there is no
scientific evidence that plant shapes and colours
help in the discovery of medical uses of plants
(Bennett, 2007). But the idea cannot be
discarded.

Zoopharmacognosy Animal SelfMedication

The term zoopharmacognosy to describe
the phenomenon whereby animals selfmedicate, by selecting and using plants,
soils, and insects to treat and prevent
disease (Gerber, 1998).
The term literally means animal drug
knowledge, coined from zoo ("animal"),
pharma ("drug"), and gnosy ("knowledge").
In East Africa, pregnant elephants selfmedicate by chewing the leaves of a tree
(Family:Boraginaceae) that induces labor.
Incidentally, Kenyan women also use this
tree for the same purpose (Linden, 2002).

 herbalism developed from necessity, trialand-error, and serendipity, rather than from
phased trials as we know them today.
Still the term herbal clinical trials is not a
misnomer since a certain amount of human
experimentation must have taken place at
some stage in the long history of herbal
medicine
opium, mandrake, tea, coffee, volatile oil
(sandalwood oil, rose oil), fruit juice, salt
solution, Herbs and spices stand out as
herbal remedies that have a long history of
application in TM

Herbal Clinical Research at

a Glance

General purpose:
The general purpose of an herbal clinical trial is
to generate safety and efficacy data needed
to guide the use of an herbal medicine.
Approval
The trial can only take place when the
respective national regulatory authority is
satisfied with the quality of data provided on:
1.The safety and efficacy of the drug.
2.The necessity for the trial.
3.How the trial is to be carried out that is: a
detailed study protocol.
4.The capability of investigators/ sponsor.

 Principles of pharmacodynamics to herbal

drugs:
Principles of pharmacodynamics to herbal drugs
invariably lead one of the following three scenarios:
1. Herbal drugs whose efficacies have been
demonstrated -their active principles are known
and their doses are more-or-less established.
2. Herbal drugs whose efficacies are probable, but
have not been clearly demonstrated - their active
agents may be used to standardize them.
3. Herbal drugs with uncertain efficacies, but a long
history of traditional usage such drugs can be
used for treating common disorders, but should be
used exactly as in the traditional practice.

 Methodologies of herbal clinical studies:

1.Administration of the drug to selected
subjects.
2.Collection of data on the subjects conditions,
such as: measurements of vital signs,
concentration of the drug in the blood or
other fluids, whether the patient's health
improved or not, and so on.
3.The data collected are subjected to statistical
analysis.

TRADITIONAL HERBAL REMEDIES IN THE

CONTEXT OF PHASED CLINICAL TRIALS
Phase I:
First trial of an herbal remedy or formulation
is carried out with a small number of
healthy volunteers or patients suffering
from the disease for which the remedy is
intended.
The main purpose is to observe tolerance
to the remedy
To get an indication of the dose that
might be used safely in subsequent studies.

Phase II:
Although phase II studies are often
preferably designed as randomized,
doubleblind,
controlled studies, using for control
groups either an existing alternative
treatment or a placebo; such is
uncommon with long standing herbal
remedies.
The dosage schedules established in
phase II studies are used for the phase III
study.

Phase III:
A phase III trial of an herbal drug involves a
large patient group studied at several
centres using a randomized double-blind
design.
To validate preliminary evidence of
efficacy obtained in phase II. As in the
case of conventional drugs,
herbal phase III trials are conducted under
conditions that are as close as possible to
the anticipated conditions of normal
use.

Phase IV:
Phase IV studies are desired for an
herbal
remedy,
they
may
be
performed after the dosage form is
made fully available for general
use.
The main purpose of such studies is
to
detect
toxicities
and
idiosyncrasies that may occur so
rarely that they are not detected
earlier.

 Double-blinded
and
well-designed
clinical trials have also been conducted
with
Argyowardhani in viral hepatitis.
Mucuna pruriens in Parkinsons disease.
Phyllanthus amarus in hepatitis
Tinospora cordifolia in obstructive
jaundice

Global status of Herbal Clinical

Research:

In 2002 the US National Center for

Complementary and Alternative Medicine
(NCCAM) of the National Institutes of
Health (NIH) began funding clinical trials
into the efficacy of herbal medicine
(Herbal Medicine-NIH-NCCAM, 2011).
In a survey conducted in 2010, 356 of
1000 herbal products available in Europe
and North America had published trial
results on "pharmacological activities and
therapeutic applications" (Cravotto et al.,
2010).

References

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the
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States
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