Clinical Trials & Evidence-Based Herbal Medicine
Corresponding author: [email protected]
Abstract
The increasing worldwide popularity of herbal medicine has heightened the necessity for stringent clinical trials to ascertain its safety, efficacy, and therapeutic value in evidence-based healthcare. While traditional medical systems offer substantial empirical information, contemporary clinical research is crucial for validating herbal therapies using standardised scientific methods. Randomised controlled trials, pragmatic clinical research, systematic reviews, and meta-analyses are essential for producing high-quality evidence about herbal therapies. The standardisation of herbal formulations, quality assurance, pharmacovigilance, biomarker-guided evaluations, and regulatory compliance augment the reliability and repeatability of clinical outcomes. Innovations in trial design, digital health technology, real-world evidence, and artificial intelligence are enhancing participant monitoring, data integrity, and personalised therapy assessment. This chapter reviews the principles and methodologies of clinical trials for herbal medicine, the challenges of generating robust evidence, and the ways in which integrating clinical data with traditional knowledge can foster the rational, evidence-based application of herbal medicines in women's healthcare.
Author Affiliations
- 1 Department of Pharmacology, Dr. Kolpe Institute of Pharmacy, Kolpewadi, Tal. Kopargaon, Dist. Ahilyanagar 423602, Maharashtra, India.
- 2 Department of Pharmaceutical Chemistry, Rashtriya College of Pharmacy, Hatnoor, Tal. Kannad, Dist. Chhatrapati Sambhajinagar 431102, Maharashtra, India.
- 3 Department of Pharmaceutics, SND College of Pharmacy, Babhulgaon, Tal. Yeola, Dist. Nashik 423401, Maharashtra, India.
- 4 Department of Pharmaceutical Quality Assurance, Dr. Kolpe Institute of Pharmacy, Kolpewadi, Tal. Kopargaon, Dist. Ahilyanagar 423602, Maharashtra, India.