Transcript Clinical Pharmacology in Ayurveda – Current status and scope

Clinical Pharmacology in Ayurveda
Current status & Scope
Dr.T.P.Rajmohanan
Asst.Professor
College of Pharmaceutical Sciences
Govt. Medical College, Trivandrum
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When a drug is
given
A risk is taken
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What is clinical Pharmacology?
Clinical Pharmacology is a
branch of
pharmacology which bridges classical
fundamental pharmacology with Pharmacotherapeutics and clinical medicine and mainly
involves study of drugs in Humans
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Role & Importance of clinical Pharmacology
• Explores the safety parameters of the existing medications
• Monitors side effects: A single drug may have more than one effects.
• Adverse effects: detection, identification, monitoring, management
and reporting
• Vigil for drug toxicity: Toxicity is exaggeration of pharmacologic
response and is dose related
• Monitoring inter actions: drug-drug and drug-food interactions
• Monitor contraindications : imposes precautions and cautions
• Provides tailor made therapeutic regimen: adjustment and titration
of doses for a particular individual
• Optimization of therapeutic benefits: with existing drugs by
assessing risk versus benefit
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Primary obligations of Clinical Pharmacology
1. Optimize therapeutic benefits and safety with
already existing medications.
2. To provide new, improved Pharmaco-therapeutic
candidates by complementing the drug
development process
3. To imbibe the development and advancements in
science, intervene, improvise and improve the
ongoing pharmaco-therapeutic paradigms so that
it can face the challenges, needs and status of the
day.
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Drug development in modern medicine
Drug Molecule
Evaluation of In vitro & animal Pharmacology
Clinical Pharmacology Data in Humans (Phase I-III)
Marketing
POST MARKETING SURVILENCE (Phase IV)
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Drug development in modern medicine
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Chronology of development of a new drug
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Evaluation of Pharmacokinetics
Absorption: will it be absorbed orally? Else, from
which site? To what extent? What are the hindering
factors? Etc.
Distribution: Wide or narrow? Whether cross BBB &
BPB? To what extent? What about tissue penetrability?
Whether Protein bound? To what extent? Etc
Metabolism: Whether metabolized or not? What
fraction? Whether metabolite is active/toxic or not?
What are the metabolites? How and where? Etc
Excretion: Whether unchanged or not? Which route?
Whether entero-hepatic cycling? What enhances
/hinders elimination, what is the elimination kinetics etc
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Consideration of Factors determining route and dose
• Factors influencing rate of absorption: Food, Gastric
pH, Route of administration; solubility , co-morbidity etc
• First-pass effect: Drug absorbed by small intestine; liver
first metabolizes drug; remaining drug not sufficient to
produce therapeutic effect
• Entero-hepatic recycling:
• Age, gender, metabolic disorders etc.
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Distribution
• Systematic circulation: Drug distributed to
various body tissues and target sites - interact
with specific receptors in body
• Factors affecting distribution: Ionisation,
Pka, Protein binding, blood flow, solubility,
O/W partition coeft. Etc.
• Quick or slow ?
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Metabolism & Elimination
• Body changes drug to a more or less active form for
excretion
• Excretion: Elimination of drugs from the body
• Active metabolites: Long duration of action-low
dose
• Hepato-renal insufficiency: Require dosage
reduction and careful monitoring of kidney function
• Older adults: Diminished kidney function - require
careful monitoring and lower dosages
• Co-morbidity: May warrant special attention
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Half- life: Determine dose frequency
• Time required for the body to eliminate 50% of the
drug
• Drugs with short half-life: Administered frequently
• Drugs with long half-life: Require less frequent
dosing
• Difficulty in drug excretion: Increases half-life and
risk of toxicity
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Onset, Peak, CSS and Duration
• Onset of action: Time between drug administration
and beginning of therapeutic effect
• Peak concentration: Absorption rate equals
elimination rate
• Duration of action:
• Steady state concentration: Determines whether
consistent concentration is maintained for the
therapeutic effect or not on repeated dosing
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Elucidation of Pharmacodynamic Profile
• Does the drug has got the desired effect?
• Whether the primary effect is the desired therapeutic
effect?
• What are the physiologic changes produced by the drug?
• What are the biochemical mechanisms behind its action?
• What is the main mechanism? Is there additional
mechanisms involved?
• Which are the drug targets? Is the action specific or not?
• Is not specific, what are other targets? Which are the
secondary effects?
• Whether the secondary effects adverse or not?
• Whether the secondary effect is beneficial in other cases?
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The mechanism of action
• Drug interacts with receptor  function of a
cell alters
• Drug molecule joins with reactive site
(receptor) on surface of cell
• Agonist: Binds with and stimulates receptor therapeutic response
• Antagonist: Joins with but does not stimulate
receptors; prevents drug response;
competitive/noncompetitive
• Extent of response v/s dose Potency
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Evaluation of Safety in pregnancy
• Teratogenicity
• Mutagenicity
• Effect on foetal growth
• Organ differentiation
• Congenital abnormalities
• Look for abortion/foetal death
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Evaluation of drug reactions
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Allergic drug reactions
Drug idiosyncrasy
Drug tolerance
Cumulative drug effect
Toxic reactions
Pharmacokinetic reactions
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Drug Interactions
• One drug interacts and interferes with the action
of another drug
• Effects: Additive; synergistic; antagonistic
• Drug interaction in special types of patients
• Drug-food interaction: Food may impair or enhance
its absorption
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Clinical trials
(Elucidation of Clinical Pharmacology Profile in Humans)
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Consists of 4 Phases:
Phase-I
Phase-II
Phase-III
Phase-IV (Post marketing)
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PHASE-I
• It is an open study: Both the investigator and
volunteer know what the volunteer gets
• Conducted in healthy human volunteers (20-80
members) with written consent
• It is conducted by Clinical Pharmacologists
• It brings out data regarding Toxicity as well as
Pharmacokinetic profiles
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PHASE-II
• With utmost care, the drug is administered to
about 100-200 patients
• Aim is to gather Pharmacodynamic dataespecially efficacy as well as adverse effects in
patients
• Done at hospitals, Single blinded studies
• Patient get either (1) Test drug (2) Older drug
(3) Placebo with randomization
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PHASE-III
• Complex, multi-centered study involving 1000-2000 or
even more patients
• Double blinded and cross over designs employed
• Gives a clear pharmacokinetic out look
• Ensures efficacy and safety
• Helps to compare the effect with older drugs
• Helps to minimize dosage errors , especially in comorbid conditions
• Done by clinicians:
• Normally, marketing permission is given only after
satisfactory results are obtained in Phase-III studies
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PHASE-IV: The most important phase
• Post marketing surveillance
• Done by all medical workers
• Mainly indented to notice adverse effects,
toxicity manifestations in co-morbid
conditions, drug –drug/drug-food and drugdisease interactions
• Most important phase since many adverse
effects are reported late after marketing-many
drug fails and need withdrawal from market
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Ayurveda: the science of life
• Ayurveda, is an ancient, self contained branch of
science, which boasts a vast history of observations,
experimentations and research- For centuries
• In contrast to other systems of medicine, it elaborates
on the way of life which can keep a harmony between
the individuals and nature.
• In spite of the truth that this system of medicine
describes the efficacy and use of anything and
everything in nature for treatment of ailments
• However, a scientific and rational explanation for their
safety and efficacy is yet to be established in several
cases.
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Ayurveda and evidence based medicine
• Unique feature of ayurveda is its holistic
approach
• It focuses on patient as an individual- not the
disease
• The treatment is for the individual not the
disease
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• Although the terms ‘CLINICAL PHARMACOLOGY’
and ‘PHARMACO-VIGILANCE’ does not appear in
Ayurveda texts, quintessence of these concepts
are vibrant and omnipresent in Ayurvedic
literatures
• It is a common belief of layman and at least, a
few practitioners, that Ayurvedic drugs as well as
anything herbal is completely safe.
• Ancient literatures clearly points out that any
drug, not properly used, can equal a poison.
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back pain
or hearing problems
fever bloating or gas
changes in appetite
coughing
diarrhea
dry mouth
ear pain
general tiredness or weakness
headache
heartburn
increased sweating
muscle pain or spasm
nausea
nervousness
runny or stuffy nose
sneezing
sore throat
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Incidence not known:
Acid or sour stomach
belching
decreased interest in sexual intercourse
difficulty with moving
inability to have or keep an erection
indigestion
joint pain
lack or loss of strength
leg cramps
loss in sexual ability, desire, drive, or performance
muscle aching
stomach discomfort or upset
swelling
weakness
Major Side Effects
If any of the following side effects occur while taking telmisartan, check with your
doctor immediately:
Rare
Changes in vision
dizziness, lightheadedness, or fainting
fast heartbeat
large hives
painful urination or changes in urinary frequency
swelling in the hands, lower legs, and feet
Incidence not known:
Blurred vision
chest pain or discomfort
confusion
dark-colored urine
decreased urine output
dilated neck veins
extreme fatigue
flushing
hives or welts
hoarseness
irregular breathing
irritation
itching
joint pain, stiffness, or swelling
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet,
or sex organs
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muscle cramps or stiffness
numbness or tingling in the hands, feet, or lips
pain or discomfort in the arms, jaw, back, or neck
pounding in the ears
rash
redness of the skin
slow, fast, or irregular heartbeat
sweating
swelling of the eyelids, face, or lips
tightness in the chest
trouble breathing or swallowing
trouble with speaking or walking
trouble with thinking
unusual tiredness or weakness
unusually warm skin
weakness or heaviness of the legs
weakness, numbness, or tingling in the arms or legs
weight gain
Minor Side Effects
Some telmisartan side effects may not need any medical attention. As your body
gets used to the medicine these side effects may disappear. Your health care
professional may be able to help you prevent or reduce these side effects, but do
check with them if any of the following side effects continue, or if you are concerned
about them:
Less common:
Abdominal or stomach pain
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Maharasnadi kashayam
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A poison in right hands may
become A medicine
A medicine in wrong hands may become
A poison
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Two types of Ayurvedic medicines
• Classical products : Those that are to be
clinically evaluated for same indication for
which it is being used or as has been described
in the classical authoritative texts of Ayurveda
• Patent or Proprietary products: formulations
containing only such ingredients mentioned in
the formulae described in the authoritative
books of Ayurveda
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Principles of Clinical Pharmacology in ayurveda
• The decision making regarding prescription of
a medicine relies up on Yukthi of the
prescriber
• His/her assessment of the roga, rogi bala,
kaala, desa, satwa, satmya, adhara sakthi and
vyayama shakthi.
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Ayurveda: Challenges
• Major challenges for ayurveda at present is
industrialization and globalization
• Both of these warrants standardization and
quality assurance in every aspects
• There is a great need for scientific research in
Ayurveda to explain its principles in the
modern context so that it becomes more
evidence based.
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Why New concepts??
Man changed everything
Everything changed man
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Significance of Principles of Clinical
Pharmacology & Pharmaco-vigilance in
Ayurveda
• To improve therapeutic outcome and safety in
relation to the use of conventional as well as
patent and proprietary Ayurvedic medicines
• To contribute to the assessment of benefit, harm,
effectiveness and risk of Ayurvedic medicines,
encouraging their safe, rational and more effective
use
• To promote understanding, education and clinical
training in Pharmaco-vigilance and its effective
communication to health professionals and the
public.
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Reports of heavy metal poisoning in
Ayurvedic medicines: Facts
• In 2011, a cluster of reports came from a
community of users of Ayurvedic remedies
• The blood samples of the patients were
screened for heavy metal levels.
• The results showed that 46 of 115 participants
(40%) had elevated blood lead levels of
10 μg/dl or above, with 9.6% at or above
50 μg/dl.
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• Rasa shastra, the practice of adding metals,
minerals or gems to herbal preparations, is well
documented - So this might have occurred by
improper manufacture/ QC of the preparations or
due to improper dosing.
• Adverse reactions to herbs are described in
traditional Ayurvedic texts, but practitioners tend
to be reluctant to admit that their remedies could
be toxic and that reliable information on their
risks is not readily available.
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Pharmaco vigilance in ayurveda: The obstacles
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False belief that all herb based drugs are safe
Ignorance among some physicians
Lack of initiative from the physician to retrieve data from patients
Low levels of ADR detection and REPORTING
Too many formulations with multiple ingredients are difficult to
monitor
Co- morbid conditions and co-administered drugs (allopathic)
Lack of idea about the shelf life of products and expiry date
Bulk dispensing of toxic drugs
Methods to study drug safety problems in the modern context have
not evolved adequately in Ayurveda.
Information related to medicines are in the form of slokas in the
texts, it is not easily available for general public.
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Other pitfalls…..
• Inadequacy of the curriculum in covering ADR and ADR
detection, monitoring and management principles
• Inadequate facilities and expertise to evaluate the ADR
profile
• Inadequacy of QC and QA measures of formulations
• Informal pharma sector selling misbranded, spurious and
substandard products.
• Adulteration of formulations and substitution for actual
ingredients for economic considerations
• Tendency to prescribe allopathic medicine along with
ayurveda products for quick and visible effects
• Practice of self medication and non compliance by patients
• Improper formulation techniques with no logical
incorporation of additives and formulation aids other
excipients
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Some positive approaches by AYUSH
• Establishment of
the Ayurvedic Pharmacopoeia
Committee and formulation of the Ayurvedic Formulary of
India (AFI)
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AFI Part I (444 formulations)
AFI Part II (191 formulations)
Ayurvedic Pharmacopoeia of India (API)- Part-I {Volume I (80 monographs),
Volume II (78 monographs )
Volume III (100 monographs),Volume IV (68 monographs)
Volume V (92 monographs)
Volume VI (101monographs)
Volume VII (21 monographs)
(API)- Part-II-Formulations Volume I (50 monographs)
Volume II (51 monographs)
Volume III (51 monographs)
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• National Pharmaco-vigilance Programme for
Ayurveda, Sidha and Uniani drugs (2007)
• The format and protocols for ADR reporting
were discussed by AYUSH in 2008.
• A final draft was released on 29.10.2008 by
AYUSH
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What all things to be monitored
 All suspected ADR due to drugs
 All suspected ADR due to drugs and other drugs
 All suspected drug-drug or drug-food interactions
 All events during or after treatment, that may be suspected due
to the medications like hospitalization, temporary or
permanent disability, any serious reactions, any interventions
that may have undergone or even death of the patient
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Processing of ADR reports
• The information in the form shall be handled in
confidentiality.
• Peripheral Pharmaco-vigilance Centers shall
forward the form to the respective Regional
Pharmaco-vigilance Centers who will carry out
the causality analysis.
• This information shall be forwarded to the
National Pharmaco-vigilance Resource Centre.
• The data will be statistically analyzed and
forwarded to the Dept. of AYUSH, Govt. of India.
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Benefits of implementing Clinical
Pharmacology & PV in Ayurveda
• Contribute to the assessment of benefit, harm,
effectiveness and risk of medicines, encouraging their
safe, rational and more effective (including cost
effective) use.
• Promote understanding, education and clinical
training in Pharmaco-vigilance in terms of Ayurvedic
medicines and its effective communication to the
public.
• Improve knowledge and faith and acceptability of
Ayurveda among patients
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Do we need more medicines in Ayurveda?
• New forms of diseases, new drugs are needed
• It will be logical to think about new
formulations in ayurveda, without sacrificing
the basic concepts
• Various steps regarding the drug development
in modern medicine is unsuitable and
unwanted in ayurveda drug development.
However, it will be relevant to draw some
guidelines from it.
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Drug development in Ayurvedic
medicine: The lacuna
Drug combination
Evaluation of animal Pharmacology ???
Clinical Pharmacology Data in Humans???
Marketing
POST MARKETING SURVILENCE (Phase IV) ????
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XYZ PAIN BALM
Composition:
Eucalyptus oil: 10%
Turpentine oil: 5%
Methyl salicylate: 2.5%
Camphor : 5%
Menthol : 0.5%
Capsicum Oleoresin : 0.05%
Emulsifying base q.s: 100%
• FOR EXTERAL USE ONLY. KEEP OUT OF REACH OF CHILDREN
• DO NOT APPLY TO OPEN WOUNDS OR BROKEN SKIN
• IF IRRITATION OCCURS DISCONTINUE USE AND CONSULT THE
PHYSICIAN
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XYZ PAIN BALM
Composition:
Nilgiri ka Thel: 10%
Pine ka Thel: 5%
Wintergreen Ka thel: 2.5%
Karpoor : 5%
Pudin ka Thel : 0.5%
Mirchi ka extract : 0.05%
Base q.s: 100%
• FOR EXTERAL USE ONLY
• Ayurvedic medicine: Completely safe
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Plants: the backbone of Ayurveda
• India is blessed with Approx 4500 Plant species in
16 agro-climatic zones, 10 vegetation zones, 25
biotic provinces and 426 habitats.
• 18000 flowering plants
• 2500 types of algae
• 23000 types of fungi
• 1600 types of lichen
• 1800 types of bryophytes
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Need for collaborative research for new drug
formulations
• Lots of information regarding the phytochemical
composition and their pharmacological potentials are
now available.
• Regarding the scientific knowledge and skills, India
stands on the front line
• We have all kinds of technical expertise
• This provides an immense opportunity to experiment,
formulate, test and develop new drug combinations
and formulations
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Things to be remembered:
Problems with irrational drug combinations
• The ingredients having unmatched plasma half life
• Proportions do not sufficient to make peak plasma levels
• Ingredients interact chemically or physically so that it affect
the integrity or stability of the combination
• Incompatible Pharmacodynamics leading to low therapeutic
out come
• One of the drugs in the combination may be superfluous or
wasteful
• Burden of cost factors
• The incidence of adverse effects increases
• It is difficult to identify which medicine combination has
caused an adverse effect
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Avoid irrational use of drugs:
Reasons for irrational drug use
1. Lack of information related to indications & safety of
drugs.
2. Faulty & inadequate training & education
3. Poor communication between health professional &
patient
4. Lack of diagnostic facilities/Uncertainty of diagnosis:
5. Demand from the patient
6. Defective drug supply system & ineffective drug
regulation
7. Promotional activities of pharmaceutical industries:
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Hazardous outcomes of Irrational Combinations
1. Ineffective & unsafe treatment
2. Exacerbation or prolongation of illness.
3. Distress & harm to patient
4. Increase the cost of treatment
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Some studies on irrational combinations: Allopathic
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Clinical trials in Ayurveda: Limitations
• Lack of standardization and quality control of the
herbal drugs used in clinical trials
• Use of different dosages of herbal medicines
• Inadequate randomization in most studies, and
patients batch not properly selected
• Numbers of patients in most trials are insufficient
for the attainment of statistical significance
• Difficulty in establishing appropriate placebos
• Wide variations in the duration of treatments using
herbal medicines.
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Clinical trials in ayurveda: Difficulties
There are difficulties in estimation of "active"
molecules in body fluids in the pharmacokinetic
studies in phase I of drug development
Storage conditions can also alter the
bioavailability of herbal medicines
fungal or bacterial contamination resulting into
batch to batch variation
Diet component may also affect the treatment
outcome in clinical trial.
Ayurveda does not differentiate the disease from
the patient. This approach creates difficulties for
the inclusion and exclusion criteria in clinical trial
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Regulatory guidelines
• In 1993, the guidelines for the safety and efficacy
of herbal medicines developed by an expert
committee
• No new herbal medicines other than those
authorized by the licensing authorities be allowed
to be manufactured or marketed, except for those
mentioned in ancient scriptures
• The procedures laid down by the office of the
DCGI for allopathic drugs should be followed for
all traditional and herbal products to enter into
clinical trials for any therapeutic condition.
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• Co-investigators/collaborators of the expert group are
from the associations of physicians from the concerned
system for designing and evaluating the Study.
• Phase I studies may not be necessary
• Need for testing its toxicity in animals has been
considerably reduced.
• Toxicity study may not be needed for phase II trial unless
reports suggesting toxicity/herbal preparation is to be
used for more than 3 months
• Larger multicentric phase III trial is subsequently
planned based on results of phase II study.
• These trials have also got to be approved by the
appropriate scientific and ethical committees of the
concerned Institutes
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Need for immense research
Literary research -- Thorough Exploration of textual
information
Promote basic research – Find out the significance of the
ancient protocols
Promote Clinical research – In an independent manner not
mimicking modern medicine and make it ‘ more evidence based’
Identify the strengths & weakness -of Ayurveda in comparison
with other systems of medicine
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Research and documentation: Present day demand
•Emphasize on clinical research:
•Revalidate the facts explained in the texts in the current
scenario
• Derive better explanation of fundamental principles to
find out suitable treatment modalities for diseases of the
present age
•Find out feasible explanation for dose selection, dose
individualization, treatment length, and drug
combinations used.
•Document the important observations
•Share the observations and ideas with other clinicians,
researchers and public
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Present day demand
• Pin point and list out various possible effectsbeneficial or adverse- during therapy
• Share ideas about how to anticipate such
outcomes and manage them to fellow
physicians
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Generate evidence for safety and efficacy
of Ayurvedic drugs from texts, experience and
Current scientific facts and observations
• Add on your own contributions to the growth
of Ayurveda
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Opportunities in CP : Ayurveda Context
• Job potentials in scientific writing and
documentation
• AS the regulatory requirements becoming rigid,
educational institutions can start courses in
standardization, QC,QA and regulatory affairs
incorporating appropriate modification in basic
curriculum frame work
• Immense opportunities in ayurveda research and
development (R&D)in formulation technology
and cosmetology
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Let us
protect and promote
our tradition
and prosper
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Some of my efforts in finding out ADR
• Pharmacokinetic and Pharmackodynamic interaction
between Esomeprazole and Lacosamide: study in
experimental animals
• Liver toxicity of Rivaroxaban-possible mechanism:
study in experimental animals
• Depression and anxiogenicity due to
hydroxycloroquine: study in experimental animals
• Photosensitivity due to telmisartan: ADR reporting
• Possible potentiating of effects of between oral
diabetic drugs due to guava leaf extract: ADR reporting
• Sedative effect due to concurrent administration of
Pantoprazole and cetrizine- ADR reporting
Dr.TPR-AYU-Clinical Pharm-03-10-16
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