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Herbal Clinical Trials

Today more than ever, there is increasing demand for herbal treatment. Traditional systems of medicine such as Ayurveda, Siddha, Unani and Homeopathy, based on herbal medicines, have long been the cornerstones of healthcare in India, and now the world is awakening to the power of these systems. The world has now realized the potential of the systems for providing low-cost healthcare to society and their ability to provide treatment and cure for diseases considered to be incurable in the modern system of medicine.

The growing demand and global acceptance of these systems has dramatically changed the dynamics of this industry and the need for herbal treatment. Medicines and formulations which were earlier made by physicians to treat patients within their villages or neighbourhood now have to travel through the length and breadth of our country and around the world. And also the manufacturing scale has changed from a few hundred pills or couple of liters at a time to hundreds of thousands at a time.

These changes and the global reach have put tremendous pressure for clinical trials and quality control of these products and herbal clinical trial testing has rapidly progressed to keep up with this pressure. Many countries are now expecting the same level of evaluation and control for herbal medicines as they expect for the modern system of medicine. Regulatory dossiers for registration in US and Europe for herbal medicines are no different from those of modern medicine requiring clinical evaluation, and stability studies amongst other things.

Axon has been supporting the herbal industry to establish the quality of the products for close to two years now. The herbal clinical trial services offered by us include.

  • Regulatory Consultation for Registration of clinical trial.
  • Regulatory Dossier Development.
  • Clinical study reports.
  • Consent documents.
  • Statistical analysis plan.
  • Clinical study protocols.
  • Investigators' brochures.
  • Ayush dept issues good clinical practice guidelines

    With the introduction of Drugs & Cosmetics Rule 158 B since August 2010, the requirement of proof of effectiveness for licensing of patent or proprietary ASU medicine has necessitated the development of present guidelines of Good Clinical Practice. However, these guidelines are for voluntary use by the researchers interested in taking up clinical trials by using ASU medicine. Conducting clinical trials and generating evidence on the basis of these guidelines would help convincing the world about the potential scope of ASU remedies in scientific parlance and address the questions of lack of evidence and validation. Immense opportunities thus lie ahead for the stakeholders to adopt the guidelines as a tool for promoting scientific and quality clinical research for credible outcomes.

    The department of Ayush has issued good clinical practice (GCP) guidelines for clinical trials in Ayurveda, Siddha and Unani (ASU) medicines which will facilitate the researchers and institutions in adopting a standard way of good clinical practice while conducting the ASU clinical trials.

    It aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the ASU medicine under investigation are properly documented. The guidelines seek to establish two cardinal principles: protection of the rights of human subjects and authenticity of ASU medicine clinical trial data generated.

    Over the years we have worked with most of the leading companies in this field in India and supported their operations within India and around the world. Contact us today to get a customized solution for your requirements. You can use the quick query form on the right or call us now at last +91-9833031529.

    Medical Writing

    Medical writing involves precision, meticulous approach and high expertise for delivering resources that are in fact masterpieces. This is why Axon has brought together a rich pool of qualified and knowledgeable professionals who are capable of delivering high quality study protocols, integrated safety summaries, consent documents, statistical analysis plans, reports, summaries, feasibility survey reports, investigator’s brochures, narratives and other resources.

    Contact Us

    Our Experience

    Axon’s medical writing team is currently involved in the conception and creation of essential resources for clinical research based activities. Our team has been successful in delivering resources based on various application areas and subjects pertaining to clinical trials, nutraceuticals and other therapeutic areas, and a wide range of Good Clinical Practice (GCP) compliant pharmaceutical documents.

    Nutraceutical Studies Conducted

    Axon’s writers have created and conducted the following studies related to nurtaceuticals.

    • Top MNC 1

    • Activity:
      Designing and conduction of health programs
    • Focus:
      Oats
    • Scope:
      Different regions in India
    • Top MNC 2

    • Activity:
      Designing and conduction of studies
    • Focus:
      Glycemic Index, Saffola oats, Saffola wheat powder and antioxidant rich oils.
    •  
       
    • Top MNC 3

    • Activity:
      Designing and conduction of herbal studies
    • Focus:
      Treatment of severe dyslipidemia
    •  
       
    • Top MNC 4

    • Activity:
      Designing and conduction of nutritional studies
    • Focus:
      Various animal products
    •  
       

    Achievements

    Axon prides itself on the following achievements which were achieved with the contribution of our writers and their valuable insights.

    Subject: Glycemic Index studies

    Sponsor: Undisclosed

  • The study was designed in accordance to the guidelines of WHO.
  • The test subjects were kept constant for test and control for reducing the applicable time and costs.
  • Subject: Oats, Wheat powder and fiber rich powders

    Sponsor: Undisclosed

    Before shifting the responsibility of the study to us, the sponsor was finding it difficult to achieve 100% compliance and eligibility of required volunteers.

    Issues with compliance

  • The scope of the study was shifted to corporate offices from the previous scope (hospitals). This resulted in 100% compliance and eligibility of required volunteers.
  • The entire program was completed within the stipulated timeline.
  • Subject: Cooking rice bran oils, Fiber rich protein powder

    Sponsor: Undisclosed

    When the study was implemented solely by the sponsor, it failed to get response from other hospitals and no clear data was collected for the study.

    Issues with compliance and improper diet instruction.

  • The entire protocol and approach was redesigned, including the study conduction plan.
  • The new target area were hospitals with 300-500 staff strength. This helped to maintain 100% compliance and the study was successfully completed as per the decided timeline.
  • Subject: Hemoglobin Improvement in elderly patients

    Sponsor: Undisclosed

  • The study was initiated and completed as per the decided schedule and costs.
  • Subject: Facial Skin Improvement

    Sponsor: Undisclosed

  • The study was initiated and completed as per the decided schedule and costs.
  • Investigational New Drugs Projects

    Duration: 2007 - 2013

    Activity: Pariticipation and conduction of Phase 1, 3 and 4 (clinical trials) for the following companies:

    Sanofi Aventis (India) – Diabetes Trial

    Grifols (USA) - Hematology trial

    Progenics (USA) - Oncology trial

    Omthera Pharmaceuticals(USA) - Dyslipidemia trial

    Apimeds Pharmaceuticals (Korea) - Osteoarthritis trial,

    MJ Biopharm Pvt. Ltd(UK) - Immunogenicity trial

    Takeda Pharmaceutical Company Limited (Japan) - Diabetes trial

    Cumberland Pharmaceuticals(USA) - Burns trial

    BPL (USA) - Hematology trial.

    (The project management for EPANOVA study (2011-2012), India was managed by us and it was approved by the US FDA in May, 2014. The study was focused on the treatment of severe hypertriglyceridemia.)

    References

    The following references are from the Clinical Trial Registry of India

  • CTRI/2011/10/002035
  • CTRI/2012/01/002325
  • CTRI/2012/03/002492
  • CTRI/2012/12/003220
  • CTRI/2013/04/003528
  • CTRI/2014/05/004611
  • (The Clinical Trials Registry - India (CTRI), set up at the National Institute of Medical Statistics, ICMR, New Delhi is a free and online system for registration all clinical trials being conducted in India (www.ctri.nic.in). Registration of clinical trials in the CTRI is now mandatory, as per notification of the Drugs Controller General (India).