Author(s):
Carol P. Macwan, Yashvi S. Patel, Nirja J. Patel, Nisha Yadav
Email(s):
carolmacwan.ph@ddu.ac.in
DOI:
10.52711/2349-2988.2026.00052 
Address:
Carol P. Macwan*, Yashvi S. Patel, Nirja J. Patel, Nisha Yadav
Faculty of Pharmacy, Dharmsinh Desai University, Nadiad 387001, Gujarat, India.
*Corresponding Author
Published In:
Volume - 18,
Issue - 4,
Year - 2026
ABSTRACT:
Herbal medicine has evolved from an unofficial folk healing tradition into a well-known and financially important medical system. 75–80% of the world's population uses at least some plant-based treatments for primary healthcare. In the past, important medications like aspirin, digoxin, quinine, and morphine were derived from plants like willow bark, foxglove, cinchona bark, and opium poppy, indicating the continued pharmacological significance of botanical sources. Herbal products, in contrast to single-molecule pharmaceuticals, are complex multi-constituent mixtures whose composition varies with geographic origin, cultivation, harvesting, and processing. This makes standardization, safety assessment, and repeatable clinical evaluation more difficult. By offering unbiased data on safety, effectiveness, ideal dosage, and the possibility of herb-drug interactions, clinical trials are crucial to closing this gap. Additionally, they are necessary for obtaining regulatory approval and gaining access to global markets. The current literature on the justification for herbal clinical trials, the rules governing them (WHO, ICH-GCP, US DSHEA, EU THMPD, Indian NDCTR 2019 and AYUSH guidelines), the particular methodological difficulties of placebo design, blinding, and standardization, the function of marker compound-based quality control, herb-drug interactions and pharmacovigilance concerns, and the clinical evidence available for widely studied botanicals like St. Holy basil, ginger, garlic, curcumin, Ginkgo biloba, and guduchi. The global market for herbal medicines, which was valued at over USD 200 billion in 2022, is predicted to grow significantly by 2030, providing a strong commercial incentive for products with clinical validation. To improve trial design and product traceability, future directions might include cutting-edge technologies like artificial intelligence, blockchain-based supply-chain transparency, and genomics-guided customized herbal medicine. In summary, the review shows that in order to validate traditional knowledge, protect public health, and enable the responsible integration of herbal medicines into evidence-based health care systems, well-designed and ethically conducted clinical trials tailored to the unique multi-component nature of herbal products are still crucial.
Cite this article:
Carol P. Macwan, Yashvi S. Patel, Nirja J. Patel, Nisha Yadav. A Review on the Emerging Importance of Clinical Trials in Standardizing and Validating Herbal Drugs. Research Journal of Science and Technology. 2026; 18(4): doi: 10.52711/2349-2988.2026.00052
Cite(Electronic):
Carol P. Macwan, Yashvi S. Patel, Nirja J. Patel, Nisha Yadav. A Review on the Emerging Importance of Clinical Trials in Standardizing and Validating Herbal Drugs. Research Journal of Science and Technology. 2026; 18(4): doi: 10.52711/2349-2988.2026.00052 Available on: https://rjstonline.com/AbstractView.aspx?PID=2026-18-4-8