Herbal & Nutraceutical Safety Studies

Herbal & Nutraceutical Clinical Development

The expanding Nutraceutical market indicates that end users are seeking minimally processed food with extra nutritional. This development, in turn, is responsible for expansion in the Nutraceutical markets globally.

ICBio started its clinical operations by executed its first Herbal clinical trial in 2008, since then ICBio has dedicated and experienced team in conducting Nutraceutical & Herbal clinical studies. Since then several successful execution has been accomplished for products pertaining to sports nutrition, dietary supplements, herbal anti diabetic, herbal extract for Gastro-esophageal reflux disease, energy booster supplement, slimming supplements, sexual dysfunction, probiotics etc. Our skilled work force combines expertise and ability, which are the hallmarks in optimizing long lasting partnerships.

ICBio CRO is extending its services in designing and conducting clinical trials for herbal and neutraceutical products. We understand the complex issues faced throughout the life cycle of herbal and neutraceutical products and we offer innovative solutions by integrating our different services.

Herbal and neutraceutical products have become increasingly popular in recent years and companies are looking for options to develop products most efficient, as an innovative Contract Research Organization we are always seeking for new opportunities to offer our clients the most up-to-date services in various areas.

Use of plants as a source of medicine has been inherited and is an important component of the health care system in India. In the Indian systems of medicine, most practitioners formulate and dispense their own recipes. India is the largest producer of medicinal herbs and is appropriately called the botanical garden of the world. The major hindrance in the amalgamation of herbal medicines into modern medical practices is the lack of scientific and clinical data, and better understanding of efficacy and safety of the herbal products.

Clinical Studies

The common belief that "if a polyherbal product has been prepared as per the traditional system of medicine it is bound to be safe and effective" is not true. If you would like a herbal product to have an edge over the competition then it needs to have a health benefit claim. Well designed Double Blind Randomized Clinical trials can prove such health claims. India has now become the favorite destination to conduct Clinical Research due to modern facilities, high patient population and advanced data management skills.

We at IC BIO CRO have a protocol designed to meet the specific requirements of the clients in the field of clinical registration of new pharmaceutical products from phase I to phase IV, including Bioequivalence, Bioavailability, Pharmacokinetic/Pharmacodynamic studies, Statistical Analysis and Data Management strictly adhering to ICH and GCP guidelines. The company offers competitive and high quality clinical trial services to domestic and international pharmaceutical and Bio-Pharmaceutical companies.

Toxicity study/Animal study

Recent adverse events have clearly shown that all herbal products are not free from side effects and toxicity. Products that have been confirmed to have bio efficacy can then be taken up for safety studies to determine possible side effects, adverse reactions and the maximum tolerable dosages.

We at ICBIO undertake systematic animal studies of herbal extracts and formulations by utilizing appropriate models.

Toxicological Studies at our Laboratory are performed as per OECD, ICH, MHW, TGA, AYUSH, Schedule Y, etc�

Few of the types of toxicological/animal studies regularly performed are as follows.

  • Acute toxicity
  • Sub acute toxicity
  • Sub chronic toxicity
  • Chronic toxicity

We at IC BIO CRO provide technical expertise in clinical trials of herbal, neutraceutical and dietary supplement products.

Click here to Download ICBio brochure on herbal, neutraceutical and dietary supplement products.

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