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A eight-period, self-crossover, open-label clinical trial to assess the effect of Sanye Tablet on the Glycaemic Index of common carbohydrates

Mechanism of reduce blood glucose about Sanye Tablet base on inhibition kinetics and molecular conformation on a-glucosidase

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIN-16008500
Enrollment
Unknown
Registered
2016-05-19
Start date
2016-06-30
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

diabetes

Interventions

8:Sanye Tablet

Sponsors

The second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy male or female volunteers aged 18-40 years; 2. Body mass index (BMI) between 19~ 25; 3. General physical examination and laboratory, physical and chemical examination were normal; 4. No diabetes or any of the pre-diabetic state, fasting blood glucose levels in 3.9-5.5mmol/L (70-100mg/dl); 5. Not taking any medications for diabetes or insulin resistance; 6. According to GCP regulations, to obtain informed consent, volunteer subjects.

Exclusion criteria

Exclusion criteria: 1. Primary diseases of heart, liver and kidney and other important organs and digestive tract disease, metabolism of disease, nerve system disease history person; 2. Mental or physical disability; 3. Physical examination, biochemistry, urine routine and electrocardiogram, chest X-ray, ultrasound abnormalities and clinical significance; 4. History of drug dependence, drug abuse, history of alcoholism; 5. Allergies, a history of drug or food allergies, or known to the composition of the drug and the same ingredients have allergies; 6. 3 months with known to a certain organ damage drugs, had taken a variety of drugs within the past 2 weeks, 4 weeks had been applied research; 7. Abnormal signs of life (systolic blood pressure 140mmHg, diastolic blood pressure 90mmHg; heart rate 100bpm); 8. Within 6 months before the test regular drinkers, weekly drinking more than 14 units (1 unit =360ml beer or 45ml alcohol amount of alcohol for 40% of the spirits or 150ml wine); 3 months before the test daily smoking more than 1 branch; 9. Test 3 months before taking soft drugs (such as marijuana) or the year before taking hard drugs (such as cocaine, phencyclidine etc.); 10. There are other factors that may affect drug absorption, distribution, excretion and metabolism; 11. Blood donors in the last 3 months; 12. According to the researcher's judgment, should not be in the group (such as the weak, etc.).

Design outcomes

Primary

MeasureTime frame
Glycemic Index;

Countries

China

Contacts

Public ContactLi Yanfen
liyanfen2008@163.com+86 022-60335723

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026