ABSTRACT:
This study highlights the historical significance and current relevance of
traditional herbal therapy in India by examining its clinical trials and
regulatory environment. Herbal medicine, which has its roots in traditional
systems like Ayurveda, Unani, and Siddha, has become popular all over the
world since it is thought to be safe and effective. For product safety and
efficacy, regulatory frameworks such as ASU regulations, Revised Schedule
Y (2024), AYUSH pharmacopoeia (671+ monographs), and CTRI
transparency place a strong emphasis on standardisation and quality
evaluation. Thorough clinical trials navigate a 2-4-year pipeline from DNAbarcoded
authentication to Phase III RCTs by fusing conventional expertise
with contemporary techniques. India accounts for 37.6% of Asia's herbal
research, but it faces several obstacles, including polyherbal complexity,
placebo mismatches, 10,000-fold potency variations, and low public
awareness (e.g., Ghaziabad survey: 60% know Tulsi, <10% recognize
gurmar). Results show that interest is growing, bolstered by WHO initiatives
and the fact that 80% of the world's medicines are plant-based. This review,
which addresses standardisation and quality control for safe, egalitarian
healthcare, promotes the responsible promotion of evidence-validated herbal
remedies by utilising reverse pharmacology and Golden Triangle consortia
Cite this article:
Prof. Nhavale G. B., Dr. Abhishek Kumar Sen, Mr. Dnyaneshwar Pandit. Clinical Trials of Traditional Herbal Medicines in India: Current Scenario and Challenges. IJRPAS, March 2026; 5(3): 138-150.DOI: https://doi.org/https://doi.org/10.71431/IJRPAS.2026.5310