Efficacy of herbal medicinal products MCQs With Answer

Introduction:

This quiz collection on the efficacy of herbal medicinal products is tailored for M.Pharm students studying Herbal and Cosmetic Analysis (MPA 204T). It focuses on rigorous concepts used to assess therapeutic activity of botanicals — from preclinical bioassays, chemical standardization, and pharmacokinetics to clinical trial design and regulatory pathways. Questions probe analytical approaches (HPTLC/HPLC, chemical fingerprinting, bioassays), study design (randomized, placebo-controlled, dose-response), and challenges unique to complex herbal mixtures such as batch-to-batch consistency, marker selection, and herb–drug interactions. Use these MCQs to deepen understanding of how scientific evidence is generated, interpreted, and validated for herbal medicines in research and regulatory contexts.

Q1. Which study design provides the strongest evidence for the clinical efficacy of an herbal medicinal product?

• Case series
• Randomized, double-blind, placebo-controlled trial
• Open-label observational study
• In vitro bioassay

Correct Answer: Randomized, double-blind, placebo-controlled trial

Q2. For standardization of a herbal extract to ensure consistent efficacy, which approach is most commonly used?

• Quantification of one or more marker compounds by validated HPLC/HPTLC
• Relying solely on traditional preparation methods
• Visual assessment of raw plant material color
• Random batch sampling without markers

Correct Answer: Quantification of one or more marker compounds by validated HPLC/HPTLC

Q3. Which regulatory concept recognizes herbal products based on documented long-standing use rather than modern clinical evidence?

• Well-established use (WEU)
• Traditional use registration
• New chemical entity approval
• Orphan drug designation

Correct Answer: Traditional use registration

Q4. When assessing efficacy of a multi-component herbal formulation, which experimental strategy helps identify active constituents contributing to activity?

• Bioactivity-guided fractionation
• Only measuring total solids content
• Testing raw plant material without extraction
• Using single solvent without fractionation

Correct Answer: Bioactivity-guided fractionation

Q5. Which in vitro assay type is commonly used for preliminary efficacy screening of herbal extracts with anti-inflammatory potential?

• Cyclooxygenase (COX) enzyme inhibition assay
• Determination of melting point
• Residual solvent analysis
• Moisture content measurement

Correct Answer: Cyclooxygenase (COX) enzyme inhibition assay

Q6. In herbal clinical trials, which endpoint is considered a surrogate endpoint rather than a direct clinical outcome?

• Reduction in pain score reported by patient
• Improvement in overall survival
• Change in inflammatory biomarker (e.g., CRP)
• Complete remission of disease

Correct Answer: Change in inflammatory biomarker (e.g., CRP)

Q7. Which challenge is most specific to demonstrating efficacy of herbal products compared with single-compound pharmaceuticals?

• Complex mixtures with multiple constituents and potential synergism
• Difficulty measuring pH of formulation
• Inability to use double-blinding
• Regulatory approval always faster

Correct Answer: Complex mixtures with multiple constituents and potential synergism

Q8. Which pharmacokinetic parameter is critical to evaluate when an herbal product contains poorly absorbed active constituents whose activity may depend on systemic exposure?

• Bioavailability (F)
• Melting point
• Ash value
• Moisture uptake

Correct Answer: Bioavailability (F)

Q9. Which analytical method is most appropriate for fingerprinting and comparative quality control of complex herbal extracts?

• High-performance thin-layer chromatography (HPTLC)
• Loss on drying
• Particle size distribution
• Acid value

Correct Answer: High-performance thin-layer chromatography (HPTLC)

Q10. Which type of clinical trial examines different dose levels of a herbal extract to determine optimal therapeutic dose and safety?

• Phase II dose-ranging study
• Cross-sectional survey
• Bioequivalence study only
• Post-marketing surveillance

Correct Answer: Phase II dose-ranging study

Q11. Which of the following best describes a validated bioassay used in herbal efficacy evaluation?

• An assay demonstrating specificity, precision, accuracy, and reproducibility for a biological response
• Any single-use assay performed without controls
• A qualitative description of color change only
• Assay limited to bacterial contamination measurement

Correct Answer: An assay demonstrating specificity, precision, accuracy, and reproducibility for a biological response

Q12. Which interaction mechanism commonly leads to clinically relevant herb–drug interactions affecting efficacy?

• Induction or inhibition of cytochrome P450 enzymes altering drug metabolism
• Change in tablet hardness
• Variation in plant leaf size
• Colorimetric interference in assays

Correct Answer: Induction or inhibition of cytochrome P450 enzymes altering drug metabolism

Q13. Which guideline or authority specifically develops scientific opinions and monographs on herbal medicines within the EU?

• European Medicines Agency Committee on Herbal Medicinal Products (EMA HMPC)
• FDA Center for Biologics Evaluation and Research
• World Trade Organization (WTO)
• International Organization for Standardization (ISO)

Correct Answer: European Medicines Agency Committee on Herbal Medicinal Products (EMA HMPC)

Q14. For confirming identity and preventing adulteration of raw botanical material, which technique is increasingly used alongside microscopy?

• DNA barcoding
• pH titration
• Evaporation residue test
• Limulus amebocyte lysate assay

Correct Answer: DNA barcoding

Q15. Which statement about placebo effects in herbal trials is correct?

• Placebo effects can be large and must be controlled by blinding and placebo comparators
• Placebo effects do not occur with herbal products
• Placebo control is unnecessary if an herb has historical use
• Placebo always produces objective biochemical changes identical to active treatment

Correct Answer: Placebo effects can be large and must be controlled by blinding and placebo comparators

Q16. When demonstrating equivalence between two herbal extract batches for efficacy, which study approach is most appropriate?

• Comparative in vitro bioassay combined with chemical fingerprinting and statistical equivalence testing
• Comparing only the bulk density
• Visual inspection by different operators
• Comparing color under sunlight alone

Correct Answer: Comparative in vitro bioassay combined with chemical fingerprinting and statistical equivalence testing

Q17. Which stability parameter directly impacts the potency and therefore efficacy of an herbal preparation over its shelf life?

• Degradation of active marker compounds measured under ICH stability conditions
• Container label font size
• Weight variation of packaging cartons
• Odor perceived by a single tester

Correct Answer: Degradation of active marker compounds measured under ICH stability conditions

Q18. In herbal pharmacology, the term “entourage effect” refers to which concept relevant to efficacy?

• Synergistic or modulatory interactions among multiple constituents in a botanical mixture
• Loss of volatile oils during drying
• Adverse reactions caused by contaminants
• Standardization to a single marker only

Correct Answer: Synergistic or modulatory interactions among multiple constituents in a botanical mixture

Q19. Which quality attribute must be controlled because microbial contamination can impact perceived efficacy and safety of herbal products?

• Total viable microbial count and absence of specific pathogens
• pH used only for cosmetics
• Tablet hardness of unrelated product
• Colorimetric assay for inorganic salts only

Correct Answer: Total viable microbial count and absence of specific pathogens

Q20. When interpreting clinical trial results for a herbal product, which evidence grading approach helps evaluate the overall strength of efficacy claims?

• GRADE (Grading of Recommendations, Assessment, Development and Evaluations)
• Only relying on expert opinion without systematic review
• Counting the number of herbs in a formulation
• Assessing only traditional texts

Correct Answer: GRADE (Grading of Recommendations, Assessment, Development and Evaluations)

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