ABSTRACT
Introduction ............................................................................................................ 318 Deˆnitions ......................................................................................................... 319
Traditional Medicines ................................................................................... 319 Herbal Medicines ......................................................................................... 319
Historical Aspects .................................................................................................. 320 Regulatory Aspects on Conducting Clinical Trials ................................................ 320
World Health Organization (WHO) Guidelines ................................................ 321 Indian Council of Medical Research (ICMR) Guidelines................................. 321 Good Clinical Practice (GCP) Guidelines......................................................... 322 Department of AYUSH, India ........................................................................... 322 Ethical Issues ..................................................................................................... 322
Limitations of Herbal and Traditional Medicine with Reference to Clinical Trials ...................................................................................................................... 323
Trial Design ....................................................................................................... 324 Randomized Controlled Trials .......................................................................... 324 Blinding ............................................................................................................. 324 Placebo .............................................................................................................. 325 Standardization or Quality Control ................................................................... 325 Ayurvedic Perspective ....................................................................................... 325
Need of Alternative Approach to Clinical Trial for Traditional Medicine ............. 326 Prakriti (Psychosomatic Constitution) .............................................................. 326 Rogi (Patient), Roga (Disease), and Pariksha (Examination) ........................... 326 Kriyakala (Interventions at Different Stages of Disease) ................................. 327 Pathya-apathya (Diet) to Be Followed with Medicine ..................................... 327 Anupana (Vehicle) for Drug Administration ..................................................... 327 Proposed Methodologies for Clinical Trials on Ayurvedic Drugs .................... 327
Toxicity Studies on Ayurvedic and Herbal Drugs .................................................. 328 Acute Toxicity (OECD Test No. 43) ................................................................. 329 Subacute Toxicity (OECD Test No. 412) .......................................................... 330 Subchronic Toxicity (OECD Test No. 413) ...................................................... 330 Chronic Toxicity (OECD Test Guideline 452) .................................................. 330 Carcinogenicity (OECD Test Guideline 451) ................................................... 330
The search for natural and safe health products has led to the recent resurgence of interest in herbal medicines. In both developed and developing countries, consumers and health care providers need to be supplied with up-to-date and authoritative information on the beneˆcial properties and possible harmful effects of herbal medicines. The potential beneˆts of herbal medicines could lie in their high acceptance by patients, efˆcacy, relative safety, and affordable cost. Patients worldwide seem to have adopted herbal medicines in a major way.
