In a context of drug development, natural medicines are ordinally focused as chemical sources. If extracts showed some pharmacological activities, active ingredients would be identified to serve drug seeds. However, extracts themselves are able to be developed as botanical drugs or functional foods. Especially, crude drugs classified as Non-drug in “Fundamental policies of ingredients (raw materials) in the food and drug classification in Japan” have an advantage of clinical study doable comparably due to anticipated safety. Based on our basic studies, clinical studies can be seamlessly performed aiming to develop products.
Today, I introduce two lines of our studies. C. tubulosa extract improved motor function in spinal cord injured mice despite of intractable chronic phase and sarcopenia model mice. The molecular mechanism of acteoside, an active constituent in the extract, was partially revealed. RCT clinical study showed that C. tubulosa extract improved walking ability in locomotive syndrome. Now, another RCT of the extract for cervical spondylosis myelopathy is ongoing.
Diosgenin showed a potent anti-dementia activity, and realized accurate axon pathfinding in the Alzheimer’s disease (AD) model mice. Detail molecular mechanism of diosgenin has clarified. RCT of diosgenin-rich Dioscorea batatas extract enhanced cognitive function in healthy adults. Now, another RCT of the extract for mild AD and MCI patients is ongoing. Our research is underway to get these two extracts on the drug approval track.