Participant Information Sheet The ORCHID Study: Polycystic Ovary Syndrome: Randomised feasibility pilot study using Chinese Herbal medicine to explore Impact on Dysfunction Principal Investigator: Lily Lai University of Southampton Approval No: 3977
We are writing to invite you to take part in a research study involving Chinese herbal medicine for polycystic ovary syndrome (PCOS). This study is a PhD study that is being funded by the National Institute for Health Research, a Department of Health organisation that funds research relevant to the NHS, and is supported by a study team consisting of GPs and researchers within the University of Southampton’s Faculty of Medicine division of Primary Medical Care.
Before you decide whether or not to take part in the study, it is important for you to understand why the research is being done and what it will involve. This information sheet provides further details about the study - please take some time to read it carefully. If you are happy to participate, you will be asked to sign a consent form during your first study visit stating that you have read this information.
1. What is polycystic ovary syndrome (PCOS)?
Polycystic ovary syndrome (PCOS) is a female hormonal condition that is typically diagnosed after at least two of the following three criteria have been identified:
1. Irregular and delayed, or no periods; 2. Excessive testosterone (checked by having a blood test, or by the presence of excessive hair
3. Polycystic ovaries (checked by ultrasound).
2. What is the purpose of the study?
Chinese herbs have long been used in China for symptoms of PCOS. Whilst some scientific research has been conducted in China, the effects of Chinese herbs have not been tested scientifically in the UK. We would like to carry out a feasibility and pilot study to see whether it is possible to test the effectiveness of this form of treatment using the same methods that are used to test Western medications. This will include seeing if women with PCOS are willing to participate, whether the questionnaires and tests we use are acceptable and whether there are any measurable effects of herbs on symptoms of PCOS.
3. Why have I been approached?
We are inviting women aged 18-44 with PCOS-related delayed or no periods to take part in this study. You may have expressed an interest about the study and asked for more information. Your healthcare provider or complementary therapist may also have provided you with this information because they felt that you may be interested.
4. Are Chinese herbs safe?
Chinese herbs are rarely associated with harmful side effects. During this study, you will be closely monitored throughout the study by qualified and experienced herbalists, your liver and kidney function will be checked as a precautionary safety measure and medical concerns will be escalated to a registered medical doctor on the study team.
The herbs in this study are routinely prescribed in the UK for symptoms of PCOS and are manufactured according to Good Manufacturing Practice (GMP). This is a recognised quality assurance standard that is required by the Register of Chinese Herbal Medicine, the UK’s main herbal regulatory body.
Participant Information Sheet, Version 5.3, Last updated 07/04/2013
5. What should I expect if I take part in this study?
As part of the study, you will be prescribed one of two types of Chinese herbs for 6 months. No placebo or dummy treatment will be used. You will have a 50/50 chance of receiving either type of herbs which will be decided randomly by a computer. During the study, neither you nor your herbalist will know which type of Chinese herbs you are taking. Over the 6 months, we will ask you to fill out some questionnaires, undergo some assessments and attend clinic visits to see a herbalist. Details are provided in Table 1.
Table 1: Outline of study tasks Location What you will be asked to do Durati on
Fill out questionnaire to check your suitability for the study which will ask
about your symptoms and your medical history. We aim to respond
regarding your suitability within 3 days of completing this questionnaire.
If found to be eligible, fill out questionnaires about your symptoms, how
you feel about PCOS and general wellbeing.
You will have the chance to ask further questions about the study. If you
agree to participate, you will be asked to sign a consent form.
10-15 minute Chinese herbal medicine consultation to ask about your symptoms and general wellbeing.
Other checks: blood test (finger prick or from arm), some measurements (weight, height, waist, hip), a brief assessment of hair growth on your back, thighs and face.
Fill out questionnaire to see how you feel about the study so far.
Follow-up Chinese herbal medicine consultation to check your symptoms
Follow-up Chinese herbal medicine consultation to check your symptoms
Fill out questionnaire to see how you feel about taking the herbs.
Follow-up Chinese herbal medicine consultation to check your symptoms
Week 12: Bring any unused herbs to this visit for weighing.
Follow-up Chinese herbal medicine consultation to check your symptoms
and general wellbeing. A study visit may be required if your herbalist
feels it is important in order to check it is safe for you to continue on in the
Fill out questionnaires about your symptoms, how you feel about PCOS
Follow-up Chinese herbal medicine consultation to check your symptoms
Other checks: blood test (finger prick or from arm), some measurements (weight, height, waist, hip), a brief assessment of hair growth on your back, thighs and face.
Bring any unused herbs to this visit for weighing.
Online/paper Invitation to complete questionnaire to provide feedback about taking part
Participant Information Sheet, Version 5.3, Last updated 07/04/2013
6. Who has approved this study?
This study has received ethical approval from the Register of Chinese Herbal Medicine, the UK’s main herbal regulatory body. This ethics committee ensures that the study is conducted according to internationally recognised ethical principles as described in the Declaration of Helsinki.
The University of Southampton Research Governance Office has also checked that the expected requirements for insurance purposes are met.
7. Where will the clinic visits be held?
Visits will be in Berkhamsted/Hemel Hempstead (Hertfordshire), and in Primrose Hill (London). Depending on the clinic, daytime and evening appointments will be available on some weekdays and on weekends. We will endeavour to arrange for your visits to be at a location and time convenient to you. Some consultations will require you to attend a study visit in order to conduct important checks e.g. safety. Other consultations can be conducted by telephone.
8. How do I take the herbs?
Your herbs will be sent to you after each consultation with the herbalist and you will receive powdered herbs in plastic bottles. A plastic measuring spoon will be provided for you to measure the correct dose of herbs. To take the herbs, place your prescribed dosage of herbs into an empty mug and mix with hot water to make into an ‘instant’ tea. This can be taken straight away. You will initially be asked to take this twice a day - morning and evening. If you are finding it difficult to take the herbs or if you are going away on holiday, please inform your herbalist who will be able to offer you further suggestions and advice, or organise a temporary break from taking the herbs. As part of the study, we will be measuring the quantity of unused herbs and will be asking you to bring in herbal containers to some study visits for weighing.
9. Can I continue with my usual medications or treatments during the study?
In most cases, this will not be a problem. However, the use of some medications and treatments are restricted for safety reasons. A study team member will go through these with you in the pre-study check.
We recommend you keep to your usual diet or levels of activity during the study.
10. What benefits could there be if I take part?
By taking part, you will be entitled to Chinese herbs and consultations with experienced herbalists, normally costing £800-1000. You will receive monitoring throughout the study and may experience improvements in some of your symptoms. Your participation in this study will be helpful in supporting research for women with PCOS, even if you do not experience improvements in your own symptoms.
11. What disadvantages or risks could be involved if I take part?
Herbs are occasionally associated with side-effects such as diarrhoea, loss of appetite and headaches in the first 48 hours. These usually subside after 48 hours and will be monitored closely by your herbalist. Herbs can sometimes aggravate current symptoms that you have but this is usually a temporary side-effect and will be monitored closely. You may experience minor discomfort or bruising following the blood test. Chinese herbs have rarely been associated with kidney or liver damage. The dosages in this study have been carefully measured and we will monitor for any such effects. If you have any concerns during the study, you should contact a member of the study team for advice immediately.
12. Will my GP be notified about taking part in this study?
We will write to inform your GP about your taking part in this study. This is in order that they are aware of any known side-effects of the herbs and possible conflicting medications. If you wish, you may also ask us not to contact your GP – this will not affect your eligibility to take part in the study.
Participant Information Sheet, Version 5.3, Last updated 07/04/2013
13. Are the herbs suitable for use whilst trying for a baby?
We strongly discourage participants from actively trying for a baby whilst taking herbs during the study. Although the Chinese herbs in this study may be helpful for preparing your body for conception, the safety of the herbs in this study has not been formally tested during pregnancy and we recommend you use appropriate contraception. It will be safe for you to try for a baby immediately after stopping the herbs.
14. Are there other reasons why I should not participate?
You may not be able to participate if you:
have allergies to herbal ingredients such as nuts, citrus fruit peel, goji berry, licorice or cinnamon;
have a history of alcoholism or problems with your liver or kidney;
have been diagnosed with any of the following medical conditions: thyroid disorders, prolactin disorders, acromegaly, congenital adrenal hyperplasia, androgen-secreting tumours of the ovary or adrenal gland, Cushing’s syndrome, genetic primary hypothalamic amenorrhoea, primary ovarian failure or genetic defects in insulin action;
are currently severely depressed or have a history of psychotic illness;
are currently pregnant or breastfeeding;
are planning to receive assisted fertility treatments e.g. IVF, Clomid within the next 6 months;
are not able to attend study visits at the available clinic locations.
A member of the study team will go through these with you before you join the study.
We will also ask you about any other medical conditions and will need to make a note of any prescribed medications you are taking to make sure it is suitable for you to take part. If you are unsure about participation, please discuss this with your GP, consultant and/or a member of the study team.
15. Will my taking part in this study be kept confidential?
Any personal details e.g. name, address will only be accessed by authorised persons such as study personnel who need to, for example, post study-related questionnaires. Under certain circumstances the study team may deem it necessary for personal details, medical information or treatment details to be disclosed, for example, in case of a medical emergency. All data collection and storage procedures will adhere to the Data Protection Act 1998. Any information you give that is collected during this study will be anonymised, treated as strictly confidential and only used for medical research. Study data may be used by other research institutions and may be audited by competent authorities but confidence and anonymity will be strictly maintained. Study data will be stored securely for a minimum of 15 years as per University of Southampton guidelines.
16. Can I withdraw if I change my mind after I have joined the study?
Yes, you are free to withdraw from the study at any point and for any reason. The study team will invite you to attend a withdrawal visit and will ask you to complete some further information as well as provide a reason for your withdrawal. However, you are not obliged to attend this visit nor provide further information or a reason for your withdrawal if you do not wish to. The information that you have provided up until the point that you withdraw will contribute to the final analysis of the study unless you specify otherwise. After you have attended the withdrawal visit, you will not be contacted by the study team for any further information.
17. What expenses will be covered?
All participants taking part in this trial will receive all Chinese herbs and consultations free of charge. We will however be unable to reimburse you for expenses that may be incurred such as travel costs.
Participant Information Sheet, Version 5.3, Last updated 07/04/2013
18. Will I have access to the research findings?
Yes, all participants will be entitled to receive a summary report of the study findings following data analysis. For confidentiality, no identifiable information will be distributed and personal results will not be available.
19. Can I continue with my Chinese herbal treatment after the study has finished?
At the last study visit, we will ask you to bring along all herbal containers that were sent out to you during the study. These containers may be empty or may contain unused herbs and will be weighed at this final visit. You will be free to either keep the remaining herbs, or to leave them with us for disposal.
You will be eligible for one further complimentary telephone consultation with a herbalist within 4 weeks of your final visit to discuss further treatment options if you so wish.
20. What happens if something goes wrong?
The University of Southampton will be insuring the study and all necessary documentation for professional indemnity and insurance will be in place in the unlikely event that something goes wrong.
Any complaints and concerns relating to this study will be taken seriously and can be directed at any time to:
Principal Investigator (PI): Lily Lai, Primary Medical Care, Faculty of Medicine, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, Hampshire, SO16 5ST 07527 929 322, Senior Member of Research Team: Professor George Lewith, Primary Medical Care, Faculty of Medicine, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, Hampshire, SO16 5ST 02380 241 073, Research Governance Office (RGO): Dr. Martina Prude, Head of Research Governance, Research Governance Office, Corporate Services, George Thomas Building 37, Room 4055, University of Southampton, University Road, Highfield, Southampton, SO17 1BJ 02380 598 848,
21. Where can I get more information?
More information can be found on the study website at:
You can also contact the principal investigator Lily Lai at any time for further information.
22. How can I register to participate?
You can register your participation using one of the three ways:
1. By visiting our study website:and following the link to the
2. By emailing Lily directly on 3. By calling Lily directly on 07527 929 322.
Thank you for taking the time to read this information sheet and for considering taking part in this study.
Participant Information Sheet, Version 5.3, Last updated 07/04/2013
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Participant Information Sheet