www.ramrakha.co.uk

A Phase 1 study to validate the regulation and methodology in the analysis of traditional herbal medicine in Clinical Research

The patient information leaflet has been designed to provide a summarise copy of the statutory requirements for informed consent of participants in clinical trials of investigational medicinal products. The requirements of informed consent are set out in Schedule 1 to The Medicines for Human Use (Clinical Trials) Regulations 2004. The Regulations transpose the provisions of the European Clinical Trials Directive (2001/20/EC) into UK law. The Human Tissue Act 2004 and Mental Capacity Act 2005 of the UK Law also set out clear parameters for informed consent in clinical research.

Researchers:

The Sponsor: Dr Sundus Tewfik BSc, MSc, PhD

University Position/Role: Senior Lecturer Pharmaceutical Science, Course Leader BSc Herbal Medicinal Science, Course Leader BSc Cosmetic Science, Placements Tutor, Research Interest Group (RIG) Co-ordinator.

Subject Specialism: Pharmacognosy, Natural products characterisation, Phytochemicals

Contacts:

Room T12-02, Tower Building,

London Metropolitan University

166-220 Holloway Road

London

N7 8DB

Telephone: 020 7133 4359,

Email: s.tewfik@londonmet.ac.uk

The Investigator: Rayish Ramrakha

Final year Student BSc Biomedical Science (Hons)

Contacts:

Through Dr Sundus Tewfik

Room T12-02, Tower Building,

London Metropolitan University

166-220 Holloway Road

London

N7 8DB

rar0215@londonmet.ac.uk

075 88 22 59 70

Phase of clinical trials: phase 1

Product to be tested: Cinnamomum (Cinnamon)

What is the purpose of the study?

Today more than ever, traditional herbal medicine is receiving scientist’s attentions in order to stimulate evidence-based research and proper archiving. Although practitioners claim that use of traditional herbal medicines can make a real difference in various therapies, there are still doubts about the monitoring of herbal practitioners, and the safety and accuracy of their therapies. Certain studies have recorded adverse reactions leading to serious damages (Journal of Chinese Medicine 1996) ^[1]. The World health organisation, with the help of 19 member countries, is setting up an International Regulatory Cooperation for herbal Medicines (IRCH) ^[2] (as from November 2005). Its aim is to protect and promote public health and safety through improved regulation for herbal medicines. The British Government, member of this committee, along with national and international health bodies is reviewing its legislation concerning the use of traditional herbal medicines. The conventional legislation of the Medicines for Human Use (Clinical Trials) Regulations 2004 ^[3] had some limitations regarding its enforcement on traditional herbal medicines. The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 [^4] was therefore introduced to give to The Medicines and Healthcare products Regulatory Agency (MHRA 2007) more legislative power and responsibility concerning the management of herbal medicines on the U.K market. The statutory document is based on the Traditional Herbal Medicinal Products Directive 2004/24 EC ^[5] by the European Union Directive. It ensures specific safety and quality standards of traditional herbal medicines on the British market. However, there is still a transitional period for old products on the market to comply with the new legislation by 2011 (MHRA 2007) ^[6].

What are we researching and why?

This project is specially designed to assess the use of these traditional herbal medicines. With the transitional period of the new legislation, the project is based on the rules of the 2004 conventional legislation. The legislation will regulate the use of a highly consumed traditional herbal medicine, Cinnamomum, in a phase 1 Clinical Trials study.

Aim: The aim of this project is to carry out a herbal medicines clinical trials under the Human Use (Clinical Trials) Regulations 2004 set up by The Medicines and Healthcare products Regulatory Agency (MHRA).

Objectives:

1. The objective of this project will mainly be focused on:

2. Application of the Medicines for Human Use (Clinical Trials) Regulations 2004 to the analysis of Traditional Herbal Medicines.

3. Ensure the use of the most appropriate documents, without causing any harm to the patient’s rights, safety and welfare according to Good Clinical Practice.

Hence, Cinnamomum will be tested as a main product in a phase 1 Clinical Trials. This will help to compare the limitations of the conventional legislation compared to the new legislation at the end of the project. A full report will be documented at the end of the study.

Why have I been chosen?

You have been chosen to represent our sample population collected randomly in order to assess the requirements needed to carry herbal medicine analysis. Cinnamon is the main product of our study.

Do I have to take part in the study?

It is up to you whether or not you take part. If you do decide to take part, you will be given a questionnaire to fill in and asked to sign a consent form. You are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive.

How will I be treated if I do not take part?

Not taking part will not affect the standard of care that you receive. Your consultant will follow you up and attend to any health problems incurred in relation to the study.

What does the study mean for me?

You will be in this study for 5 months. You will have an initial screening visit up to 2 weeks before this, which will involve finding out about your past and current illnesses and a general physical examination. It will also involve some basic blood tests. The initial screening dates will be at a mutually convenient time. Later in the study the visits will need to be at more set times and dates in order to follow your progress on the medication

Successful candidates at screening will be chosen for the study. It is divided into three visits. Cinnamon to be taken on a daily dosage will be administered to you. This study involves one clinic visit every week. You will have a weekly review to ensure that the dosage is carried out properly. Side effects encountered during the week will also be recorded. Throughout the study your weight will be recorded. Cinnamon will also have effects on your cholesterol and glucose level.

The second visit for a general check up is done after 3 months. It will involve a blood test where the effect of the herbal medicine on your glucose and cholesterol level will be analysed. There will be no weekly clinic session after this visit.

The last visit will take place 2 months after. . It will involve a blood test to ensure no on going side effect of the herbal medicine on you. Your glucose and cholesterol level will be analysed.

What are the benefits of taking part?

Although there is no guarantee that this herbal medicine will help you directly or indirectly, the information gained from this study will contribute to the analysis of traditional herbal medicines and possibly be of benefit to other people in the future.

What are the possible risks or disadvantages of taking part?

The study herbal medicine has been shown to be safe in healthy volunteers with no serious harm coming to the patients at the doses used. There were some minor side effects, the commonest being mouth inflammation.

This trial may affect any private health insurance that you have so you must check with your health insurance company if this is the case before deciding to take part.

Will my taking part be kept confidential?

All information collected during the course of the research will be kept strictly confidential. Any information about you, which leaves the hospital/surgery, will have your name and address removed so that you cannot be identified from it. The results of your study will be published for scientific purposes.

What if new information arises during the course of the study?

If new information arises during the study you will be informed.

What if something goes wrong?

It is unlikely that you will be harmed as a result of this research. In the unlikely event that this occurs, the drug company sponsoring the study will pay for all study drug and study related injuries, however all other injuries not caused by the study will be covered by contacting your personal General Practitioner (GP). If you wish to complain, or have any concerns about the way in which you have been approached or treated during the course of the study, the National Health Service complaints system will be available to you.

What if I do have any questions?

For queries please contact us on our email address, phone number or book in an appointment on the details available above on the researchers.

What now?

If you decide to voluntarily take part in this study, please fill in the patient questionnaire. You will be asked to sign a patient consent form before the start of the study.

Rayish Ramrakha

Final year Student BSc Biomedical Science (Hons)

rar0215@londonmet.ac.uk

References

1. Blackwell Richard, Adverse events involving certain Chinese herbal medicines and the response of the profession (1996) Journal of Chinese Medicine Number 50 January 1996

2. International Regulatory Cooperation for Herbal Medicines (IRCH), World Health organisation, November 2005, http://www.who.int/en/, accessed on 19th Nov 2009.

4. The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005, Statutory Instrument 2005 No. 2750, Crown Copyright 2005, http://www.opsi.gov.uk/si/si2005/20052750.htm, accessed on 19th Nov 2009.

5. Official Journal of the European Union (2004), directive 2004/24/EC of the European parliament and of the council, Strasbourg, 31 March 2004

6. MHRA (2007) Traditional Herbal Medicines Registration Scheme, The Medicines and Healthcare products Regulatory Agency, March 2007