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A randomized controlled clinical studies of Sancailianmei Particles for the Treatment of Newly Diagnosed Type 2 Diabetes Mellitus

A randomized controlled clinical studies of Sancailianmei Particles for the Treatment of Newly Diagnosed Type 2 Diabetes Mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16008440
Enrollment
Unknown
Registered
2016-05-09
Start date
2017-01-01
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 Mellitus

Interventions

Experimental group:Sancailianmei particle
The control group:acarbose

Sponsors

Teaching Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) At the age of 18-70; (2) In accordance with the diagnostic criteria of type 2 diabetes mellitus; (3) Body mass index in 18.5 kg/m2 to 30 kg/m2; (4) No drug history for treating Type 2 diabetes or Just received short-term (1 month) therapy and has been discontinued for 3 months before screening in the group; (5) poor blood sugar control after lifestyle intervention (HbA1c ranges7.0%-9.0%and FBG<=11.1mmol/L); (6) Not used antibiotics, micro ecological living bacteria preparation and lactulose before 4 weeks of visiting doctor (7) the patient who is Voluntary to participate in this study, and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) People with type 1 diabetes, Adult occult autoimmune diabetes, malignant tumor, or other autoimmune disease; (2) Gastrointestinal disease and (or) patients with periodontal disease; (3) Acute diabetes complications, including diabetic ketoacidosis, diabetes, high permeability of ketosis coma, hypoglycemia coma or severe unconsciousness hypoglycemia, etc.; (4) Severe gastrointestinal diseases, such as intestinal obstruction, intestinal ulcers or have obvious digestion, absorption, dysfunction of the patients; (5) Heart failure, unstable angina, severe arrhythmia, myocardial infarction occurred in 12 monthsSBP blood pressure > 180mmhg or DBP > 100mmhg; (6) History of liver disease such as cirrhosis of the liver, hepatitis B or hepatitis C (excluding carriers), or the AST and ALT 2.5 times higher than normal ceiling; (7) History of kidney disease or clinical diagnosis of renal insufficiency, serum creatinine greater than 1.5 mg/dl (including 132.6 mol/L); (8) With other endocrine system diseases, such as hyperthyroidism and disease of grow in quantity of cortisol; (9) suffering from severe trauma, severe infections, or surgery, as well as the treatment but not completely recovery; (10) people who have a mental illness, drug or other substance abuse or alcoholics; (11) people who are accepted Steroids or is being treated for a malignant tumor; (12) Allergies or allergic reactions to drugs used in this study; (13) Pregnancy, nursing mothers, childbearing age women not to take effective contraceptive measures, or plans to pregnancy during test, positive results of urine HCG test; (14) Participants take part in other drugs within three months; (15) Family members don't agree to participate in this test.

Design outcomes

Primary

MeasureTime frame
fasting blood glucose;2-hour plasma glucose;glycosylated hemoglobin;oral glucose tolerance test;insulin releasing test;glucagon;glucagon-like peptide-1;intestinal flora;

Countries

China

Contacts

Public ContactChenQiu

Chengdu University of TCM

chenqiu1969@163.com+86 18981885702

Outcome results

None listed

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