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Baihuloulian granules in the treatment of newly diagnosed type 2 diabetes mellitus (stomach and intestines heat syndrome): a single-arm clinical study

Baihuloulian granules in the treatment of newly diagnosed type 2 diabetes mellitus (stomach and intestines heat syndrome): a single-arm clinical study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082878
Enrollment
Unknown
Registered
2024-04-10
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Type 2 diabetes

Interventions

test group:Based on lifestyle intervention, oral administration of Baihuloulian granules four times a day for four weeks

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? Meet the diagnostic criteria for new diagnosis of T2D in Western medicine; ? Meet the diagnostic criteria for stomach and intestines heat syndrome in Chinese medicine; ? Age =18 and =65; ? Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: ?Those who have obvious acute and chronic complications related to diabetes mellitus and are not suitable to participate in the study as assessed by clinicians, including but not limited to acute complications of diabetes mellitus (diabetic ketoacidosis, hyperosmolar hyperglycemia syndrome, lactic acidosis), diabetic renal disease, diabetic peripheral neuropathy, diabetic ophthalmopathy, and diabetic foot; ? Combined with severe cardiovascular, cerebrovascular and other diseases, assessed by the clinician is not suitable for participation in this study, including but not limited to very high-risk hypertension, unstable angina pectoris, myocardial infarction, stroke, malignant tumors and so on; ? Patients with psychiatric disorders such as bipolar disorder, schizophrenia, etc. in combination; ? Patients with impaired liver and kidney functions: serum transaminases greater than two times the normal value, serum creatinine greater than the upper limit of normal value; ? Those who have experienced allergy to an ingredient of the Chinese medicine compound used in the study; ? Females of childbearing age who have recent reproductive needs; ? Those who have recent need for surgery and may interrupt the treatment program; ?Those who are participating in or have participated in other clinical studies within the past month; ? Subjects with chronic alcoholism and other adverse personal habits, and poor compliance, which, in the judgment of the investigators, may potentially affect the results of the study; ? Those who, in the judgment of the investigator, may have difficulties in follow-up or other complications after enrollment of the subject, including but not limited to unstable place of residence, frequent changes in work environment, etc.

Design outcomes

Primary

MeasureTime frame
fasting glucose;

Secondary

MeasureTime frame
2h postprandial blood glucose;HbA1c;glycosylated albumin (GAL);

Countries

CHINA

Contacts

Public ContactRensong Yue

Hospital of Chengdu University of Traditional Chinese Medicine

songrenyue@cdutcm.edu.cn+86 189 8088 0163

Outcome results

None listed

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