Government Funded Herbal Medicine Clinical Trial: Feasibility Study

EXCALIBUR STUDY

At the end of 2019, we announced Phoenix will be taking part in the UK and Chinese government-funded clinical trial to test the effectiveness of herbal medicine treating COPD (Chronic Obstructive Pulmonary Disease). 

We are working with the Centre for Evidence-Based Chinese Medicine at Beijing University of Chinese Medicine, Southampton Clinical Trails Unit (SCTU) at the University of Southampton and Anhui Jiren Pharmaceutical Company to investigate the effects of the herbal formula, ShuFeng JieDu.

Before the trial can go ahead, a feasibility study has to be conducted by the SCTU. The EXCALIBUR trial is currently underway. To conduct the trial, Jiren Pharmaceutical will be supplying 200 Investigational Medicinal Products (IMP) – 100 placebo capsules and 100 ShuFeng JieDu capsules. The IMPs will be sent from Jiren to the University Medical Centre, Hamburg where they will be quality control tested by PhytoChem, a certified herbal quality control laboratory. Once the IMPs have passed the checks, they will be imported to Phoenix HQ. 

The SCTU team are currently recruiting GP surgeries to take part in the EXCALIBUR study. Once all sites have been confirmed, the trial can start. The feasibility study will recruit 80 patients who are suffering from a COPD flare-up and prescribe them with either the herbal medicine or the placebo. All 80 patients must complete 14 days of the IMP before returning to their GP. Once the feasibility trial is over and all data is collected, the SCTU team will then have the relevant information to launch the clinical trial with China. 

The role of Phoenix in both the feasibility study and clinical trial is to store and distribute the IMPs. In preparation for the EXCALIBUR trial, two of SCTU Trial Managers, Catherine Simpson and Thomas Oliver visited Phoenix HQ at the end of last week. The visit aimed to ensure our premises, facilities and operations comply with the Medicines for Human Use (Clinical Trials) Regulations 2006. Furthermore, it is also imperative that the IMPs are kept at the correct humidity level to prevent contamination. If the IMPs fall above or below the recommended humidity level, all IMPs will be placed into quarantine and removed from the trial. 

Our facilities passed the checks but to ensure all specific storage and distribution requirements were met, Catherine and Tom took us through rigorous training, which included all the relevant paperwork and regulations. All members of Phoenix staff involved in the handling and storage of the IMPs will be trained to ensure the highest level of quality control. 

The next step in the EXCALIBUR study is to finalise the sites and to receive the IMP from China via Hamburg. Once all sites are confirmed, we hope to recruit patients from May, in time for the COPD season, which usually starts around September/October.

As always, we will continue to keep you updated throughout the process and share this great opportunity with the whole Chinese medicine community!

If you would like to know more information, please contact marketing@phoenixmd.co.uk.    

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