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Study on the characteristics of intestinal damp-heat syndrome and the intervention mechanism of Gegen qinlian Decoction in type 2 diabetes from the "bacteria- toxic- inflammation - sugar" pathogenic pathways

Study on the characteristics of intestinal damp-heat syndrome and the intervention mechanism of Gegen qinlian Decoction in type 2 diabetes from the "bacteria- toxic- inflammation - sugar" pathogenic pathways

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-15006626
Enrollment
Unknown
Registered
2015-06-19
Start date
2015-06-01
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

Type 2 diabetes

Interventions

Treatment group:Gegen qinlian Decoction (granules)
placebo group:placebo
Healthy control group:none
control group of T2DM without damp-heat syndrome of intestinal:none

Sponsors

Guang’anmen Hospital,China Academy of Chinese Medicine Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. T2DM with damp-heat syndrome of intestinal: (1) signed the informed consent; (2) conforms the 1999 WHO criteria of type 2 diabetes mellitus. After screening period (diet control and exercise therapy after 2 weeks), FBG>=7.0mmol/L, but =11.1mmol/L; (3) HbA1c>=7.0%; (4) damp-heat syndrome of intestinal according to TCM syndrome differentiation; (5) aged 30-65. 2. healthy persons: (1) aged 30-65; (2) the normal constitution according to TCM criteria; (3) BMI in 18-24kg/m2; (4) no abnormal in the health examination. 3. T2DM without damp-heat syndrome of intestinal: without damp-heat syndrome of intestinal according to TCM syndrome differentiation; the rest is the same as item 1.

Exclusion criteria

Exclusion criteria: 1. Previously on diabetic therapy (including other traditional Chinese medicine and Western medicine, physical therapy, psychological therapy and health food, etc.) for up to 6 months above, group 1 month before the use of hypoglycemic, lipid-lowering drug therapy; 2. Diabetic complications, or other serious disease; 3. Blood pressure cannot be well controlled; dosage and types of antihypertensive drugs cannot remain stable; 4. In the last month, patients who had ketoacidosis, lactic acidosis, hyperosmotic coma and other acute complications of diabetesas well as infection; 5. Women who were in pregnancy or in lactation; and patients suffered from mental disease; Patients who were allergic to ingredients of Chinese drugs; 6. Patients who participated in other clinical studies 1 month before attending the study; 7. Alcohol and / or psychoactive substances, drug abusers and addicts in the past 5 years; 8. Patients who were unwilling to cooperate (unable to control the diet and take drug according to regulations, thus influencing the therapeutic effect); 9. Patients who had dysfunction of the liver and kidney; 10. Hypoglycemia.

Design outcomes

Primary

MeasureTime frame
HbA1c;TCM Syndrome;

Secondary

MeasureTime frame
Insulin secretion (0h, 1h, 2h);Lipids (CHO, TG, HDL-c, LDL-c);waist;weight;hip;Fasting blood glucose;2 - hr plasma glucose;

Countries

China

Contacts

Public ContactXiaolin Tong
xiaolintong66@sina.com+86 13910662116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026