JRCT ID: jRCTs071200042
Registered date:13/10/2020
Hesperidin (SHINJIMUN) blood perfusion trial
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | N/A |
Date of first enrollment | 13/10/2020 |
Target sample size | 14 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Arm A:Fermented Shekwasa (SHINJIMUN) 4 tabs/day given on day 1 to 7 and then Placebo 4 tab/day given on day 8 to 14. Arm B:Placebo 4 tabs/day given on day 1 to 8 then ermented Shekwasa (SHINJIMUN) 4 tab/day given on day 8 to 14 |
Outcome(s)
Primary Outcome | Amount of Peripheral blood perfusion (ml/min) |
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Secondary Outcome | 1. Serum Hesperetin concentration 2. Intracranial SpO2 (%) 3. Serum Hexanoyl Lysine concentration 4. Stool 5. Serum Triglyceride level |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | < 70age old |
Gender | Both |
Include criteria | 1. Male and female patients, 20-70 years old 2. Written informed consent 3. For participants taking medications (including supplements and dietary supplements), those who have not changed their dosage and administration during the study period |
Exclude criteria | 1. Renal dysfunction (eGFR<30ml/min/1.73m2) 2. Liver cirrhosis 3. Clinical evidence of cholestasis 4. Active cancer 5. Pregnant or lactating female 6. Participant deemed inadequate to this study |
Related Information
Primary Sponsor | Inafuku Hitoshi |
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Secondary Sponsor | |
Source(s) of Monetary Support | CATARIST RYUKYU |
Secondary ID(s) |
Contact
Public contact | |
Name | Hitoshi Inafuku |
Address | 207 Uehara, Nishihara, Okinawa Okinawa Japan 903-0215 |
Telephone | +81-98-895-1168 |
hitoshiinafuku@yahoo.co.jp | |
Affiliation | University of the Ryukyus Hospital |
Scientific contact | |
Name | Hitoshi Inafuku |
Address | 207 Uehara, Nishihara, Okinawa Okinawa Japan 903-0215 |
Telephone | +81-98-895-1168 |
hitoshiinafuku@yahoo.co.jp | |
Affiliation | University of the Ryukyus Hospital |