Skip to content

The study of Hot Spring Water 99

Efficacy and Safety of Hot Spring Water 99 of Blood Glucose and Intestinal Variability: An Open Randomized Placebo-Controlled Two-sequence Two-Phase Crossover Phase IIb Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1070220018
Enrollment
20
Registered
2022-06-21
Start date
2022-07-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia

Interventions

1) Onsensui 99 Period: Hot spring water 99 (manufactured by SOC Corporation., 500 mL, three times a day) Drink three times a day (167 mL each time, 500 mL total) before each meal. 2) Saigaiyou Bichi

Sponsors

Ohishi Mitsuru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients providing written informed and consent to participate in the study. 2) Aged >= 20 years (irrespective of sex). 3) Patients with HbA1c levels in the boundary range(5.6-6.4%).

Exclusion criteria

Exclusion criteria: 1) Patients who have taken, or plan to take during this study, medications that may affect this study (antiallergic drugs, bowel preparations, laxatives, etc.) since the pre- test. 2) Patients who regularly use medicines for diabetes. 3) Patients who have taken antibiotics before one month prior to the start of drinking water for study, or plan to do so during this study period. 4) Patients who have been using food for specified health uses, functional foods, supplements, or health foods that may affect this study for more than 3 days a week prior to participation in this study. 5) Patients with a history of appendicectomy. 6) Patients who have undergone surgery that may affect the test within six months prior to the date of the pre-test (colonoscopy, removal of gallstones or gall bladder, gastric bypass surgery, etc.) 7) Heavy drinkers of alcohol. 8) Patients with extremely irregular dietary habits or irregular rhythms of life (shift workers, late-night workers, etc.) 9) Patients who are during participating in a clinical trial of another drug or health food, or who plan to participate in another clinical trial within 4 weeks after the completion of this trial or after consenting to participate in this trial. 10) Pregnant women, those who plan or may become pregnant, and those who are breastfeeding. 11) Patients with a history or current history of serious diseases of the heart, liver, kidney, digestive organs, etc. 12) Patients with allergies to medicines or food. 13) Patients who have donated component blood or 200mL whole blood for the month prior to the screening test. 14) Men who donated 400 mL of whole blood for 3 months prior to the screening test. 15) Women who donated 400 mL of whole blood for 4 months prior to the screening test. 16) Men whose blood collection volume from 12 months prior to the screening test plus the total planned blood collection volume for this study exceeds 1200 mL. 17) Women whose blood collection volume from 12 months prior to the screening test plus the total planned blood collection volume for this study exceeds 800 mL. 18) Employees of SOC Corporation and their families. 19) Patinets who are judged inappropriate to participate in this study by the principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Blood sugar level at a month after the start of feeding.

Secondary

MeasureTime frame
1) Blood sugar-related levels at a month after the start of feeding. - HbA1c - Insulin 2) Uric acid related values at 1 month after starting intake. - Uric acid 3) Uric acid excretion rate in urine at 1 month after the start of intake. - Urinary uric acid excretion rate 4) Lipid profile values at 1 month after the start of intake. - High density lipoprotein cholesterol - Low density lipoprotein cholesterol - Triglyceride 5) Liver function measurements at 1 month after intake. - Gamma-glutamyl transpeptidase - Alkaline phosphatase 6) Intestinal environment at 1 month after intake. - Intestinal microflora

Contacts

Public ContactAkihiro Tokushige

Kagoshima University

akihiro@med.u-ryukyu.ac.jp+81-99-275-5318

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026