International Journal of Research in Pharmacy and Allied Science

ISSN: 2583-6544   |  Issues per year: Monthly  |   Indexed In: Google Scholar, CORE, ScienceOpen, Researchgate

ISSN:2583-6544

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Clinical Trials of Traditional Herbal Medicines in India: Current Scenario and Challenges

Author(s): Prof. Nhavale G. B.1, Dr. Abhishek Kumar Sen2, Mr. Dnyaneshwar Pandit3

Email(s): 1panditdnyaneshwar75@gmail.com

Address:

    Pratibhatai Pawar College of Pharmacy, Shrirampur, Ahilyanagar, Maharashtra, India-413739

Published In:   Volume - 5,      Issue - 3,     Year - 2026

DOI: https://doi.org/10.71431/IJRPAS.2026.5310  

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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

Keywords:

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


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