In order to be able to conduct a clinical trial into Chinese herbal medicine we have had to use the best quality herbs that have been properly tested to ensure they have been correctly identified (authenticity) and are free from unwanted contaminants such as heavy metals, bacteria and fungi. In this section we describe where the herbs come from and how they are being manufactured for this trial.
The dried herb extracts used in the RUTI trial have been manufactured in China by Jiangyin Tianjiang Pharmaceutical Co., Ltd, and supplied in the UK by Phoenix Medical Direct. Herbs dispensed in capsules via GP practices will be prepared by Essential Nutrition Ltd.
The rigorous controls and checks that are applied to these companies involved in our herbal supply chain mean that we are confident that we are using high quality herbs that are properly identified and free from any unwanted contaminants.
Herb production in China
Jiangjin Tianjiang Pharmaceutical Co. is a Chinese state approved supplier of dried herbs extracts that also has Good Manufacturing Practice (GMP) certification from the Australian Therapeutic Goods Association (TGA). Every herb used in the trial is collected from either wild or specially cultivated fields in China. These herbs are dried, stored and processed according to traditional methods but using modern methods of production. Each herb supplied has a Certificate of Analysis and is tested for authenticity, heavy metals, microbial and fungal contamination.
Herbal granules are manufactured by cooking individual herbs in 20 x water which are then spray dried to produce a dried powder. All manufacturing procedures have been evaluated by and conform to the GMP requirements of the Australian TGA which is also accepted by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
Importing and dispensing the herbs in the UK
These herbal granules are then imported into the UK by Phoenix Medical Ltd, who are an Approved Supplier within the Register of Chinese Herbal Medicines (RCHM) Approved Supplier scheme. This means that their storage and dispensing facilities are regularly checked and assessed to be of high standard.
Preparing the herbs for the RUTI trial
Analysis, encapsulation, packaging and distribution of the herbal medicines will be undertaken by Essential Nutrition. Essential Nutrition are an MHRA licensed GMP manufacturer for clinical trials. Essential Nutrition will be responsible for testing for herb authenticity using Thin Layer Chromatography (TLC) and for stability testing of the herbal product during the trial.