OUR PRODUCT

SE_H1 is a well-standardized, phytochemically characterized, simplified proprietary Botanical Formula derived from the Oriental Medicinal Herbal Extract,  Xiao-Chai-Hu-Tang or XCHT in Chinese, also known as Sho-Saiko-to or SST in Japan. SST/XCHT is an aqueous extract of seven herbs: Bupleurum chinense (Chai-Hu), Pinellia ternata (Ban-Xia), Scutellaria baicalensis (Huang-Qin or Chinese skullcap root), Zizyphus jujube var. inermis (Da-Zao or jujube fruit), Panax ginseng (Ren-Shen or ginseng root), Glycyrrhiza uralensis (Gan-Cao or licorice root), and Zingiber officinale (Sheng-Jiang or ginger rhizome). Traditionally SST/XCHT has been used to treat a variety of liver and gallbladder diseases and disorders and has been well-tolerated by the majority of patients. 

In the United States, Memorial Sloan-Kettering Cancer Center New York, New York has conducted two clinical trials with SST in patients with liver cancer and hepatitis C. 

1. Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed (NCT00040898)

2. SHO-SAIKO-TO for Patients With Chronic Hepatitis C: A Phase II Study (NCT00590564). 

Safety of SST/XCHT: The dose and length of treatment in the NCT00590564 trial was 2.5 gm SST granules three times a day for 52 weeks. Results showed that there were 12.5% (3/42 patients) serious adverse events. Among non-serious adverse events, liver enzymes, Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) were found to be elevated in 45.83% (12/25) and 25% (6/24) patients. Gastrointestinal and hepatobiliary disorders and albumenia were reported in 8.33%, whereas hyperglycemia was reported in 16.67% patients.

Our research has shown that SST/XCHT can significantly prevent irinotecan-induced severe delayed onset diarrhea (SDOD) in mice and rats by protecting against the SN_38 mediated downregulation of intestinal detoxifying enzyme, uridine glucuronyl transferase UGT that help reduce the exposure of ileum and colon to SN-38.  The major key active constituents in SST also moderately inhibit the microbial beta-glucuronidases (GUS) enzyme responsible for the conversion of non-toxic SN-38-glucuronide to gut toxic SN-38 by the gut microbiome. Due to its local mechanism of action, SST/XCHT can uniquely target the intestinal exposure of SN-38, without significantly impacting the systemic levels and anticancer efficacy of SN-38 in the xenograft mouse model. Currently, a randomized clinical trial (NCT04926545) studying the safety and preliminary efficacy of XCHT on Irinotecan-Induced Gut Toxicities is underway in China.

Based on these promising data, Sanarentero is developing a simplified botanical product with proprietary ratio of active herbs resulting in a more potent anti-SDOD actionproduct than XCHT/SST with fewer herbs, better quality control, and reduced side-effects liver toxicity associated with SST.