Clinical Evidence Herbals

8/3/2019 Clinical Evidence Herbals

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Clinical Evidence toEstablish Confidence in

Herbal ProductsGemiliano D. Aligui, MD, MPH, PhD

Associate Professor & Research Director, Ateneo School of Medicine & Public HealthHead of Research, The Medical City

Faculty, UERMMMCI Graduate SchoolPresident, Asian Foundation for Tropical Medicine, Inc.

Wednesday, February 15, 12


2/17

Confidence

Public trust in determining safety andefficacy of the herbal product

Level of confidence must relate to:

Safety at specific conditions (drug-drug,

drug-food interactions)

Specific Indications (not a global claim)



3/17

This talk will limit to the medicinal productsonly in which the final product conforms

with the definition of a herbal medicine

Herbal Medicines - are finished, labelled

medicinal products that contain as active

ingredient(s) aerial or underground part(s)

of plants or any other plant material, or

combination thereof, whether the crudestate or as plant preparations.



4/17

Clinical Evidence

There are two Administrative Ordersreferring to Herbal Products

A.O. 184 s2004 - Guidelines on theRegistration of Traditionally-Used Herbal

Products

A.O. 172 s2004 - Guidelines on theRegistration of Herbal Medicines

by virtue of regulatory requirements



5/17

A.O. 184 s2004

The claim is limited to the folkloric use Required to state on the label

The Traditional application/use of thisproduct has not been evaluated by thePhilippine Food & Drugs Administration

If symptoms persist, consult your doctor Not allowed for use in pregnant, lactating

mothers, and children below 18 years.



6/17

A.O. 172 s2004

Galenicals - Phase 1 trial Pharmaceutical Dosage - Phase 1, II ClinicalTrials

Indications - Phase III Clinical trials

Establish the clinical efficacy



7/17

What constitutes Public

Trust?

Clinical Trials done under ethical standards

Good Clinical Practice Guidelines

Conform with the accepted norms orethical procedures by which the products

was evaluated in a clinical trial



8/17

A.O. 172 s2004 further

states that:

Validated by the National Integrated

Research Program on Medicinal Plants

(NIRPROMP of the PCHRD-DOST)

Validated by other competent research

centers accredited/approved by Phil FDA

This regulatory condition adds to the list of regulatory

requirements that establish confidence



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Initiating the Trial

Clinical Trial Requirements

Investigators Brochure

Clinical Trial Protocol

ERC Review and Approval

a full documentation and process of review



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Botanical Authentication and

Chemical Characterization

Taxonomic certification from source

Validation of plant chromatographicsignatures

Validation of amounts of active ingredients

in the raw material



11/17

Product Quality

Standards

Stability Biochemical Analysis

Molecular validation

Nutritional Analysis

Certifications (others)



12/17

Preparation of the

Investigators Brochure Pre-Clinical Studies, Safety Studies done

Comprehensive literature review of allknown active and inactive ingredients

Acute LD50, toxidrome

Pharmacologic (effects) tests inlaboratory animals and in vitro studies



13/17

Preparation of the

Investigators Brochure Safety Studies done

Non-mutagencity test Sub-chronic toxicity test of 90 days if

product is intended for a ten day use

Chronic toxicity test of at least 9 months(mice); 12 months (rats)



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Clinical Trials

Phase I - Normal human volunteers forsafety (n=100)

Phase II - dose finding for efficacy,bioavailability (if applicable), (n=200)

Phase III - Randomized Clinical Trial(n=300)



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Ethical Review ApprovalParadigm of Clinical Research

Natural History of Disease

PrimaryPrevention Secondary

Prevention Tertiary

Prevention

Indications - Disease

Disease progression

Clinical Trials

Phase I, II, III

SAFETY

Bioavailability ?

INVE

STIGATORBROCHURE



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Paradigm of Clinical Research



Prevention Tertiary

Prevention


Disease progression

Clinical Trials

Phase I, II, III

SAFETY

Bioavailability ?

Eth

icalReview

Approval

INVE

STIGATORBROCHURE



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Paradigm of Clinical Research



Prevention Tertiary

Prevention


Disease progression

Clinical Trials

Phase I, II, III, IV

SAFETY

Bioavailability ?

Ethic

alReviewA

pproval

INVE

STIGATORBROCHURE

Clinical Evidence Herbals

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