Clinical study on the intervention of Tangdi prescription on spleen deficiency and phlegm-dampness syndrome of pre-diabetes and its mechanism of targeted regulation of intestinal flora -BCAA

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400084943

Enrollment

Unknown

Registered

2024-05-28

Start date

2024-05-31

Completion date

Unknown

Last updated

2024-06-03

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

Conditions

Pre-diabetes

Interventions

Experimental group:Lifestyle intervention+Tangdiefang granules

Control group:Lifestyle intervention+Tangdiefang placebo

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? It meets the diagnostic criteria of prediabetes ? it meets the TCM diagnosis of spleen deficiency and phlegm-dampness syndrome of prediabetes through syndrome differentiation by 2 deputy chief Chinese medicine doctors and above experts. ? Age 18-65 years old. ? no antibiotics have been used in the past 1 month, and there is no history of beneficial bacteriological supplementation. ?Patients can provide detailed contact information, no short-term migration, willing to cooperate with follow-up.? Sign the informed consent.

Exclusion criteria

Exclusion criteria: ? Patients with a history of diabetic ketoacidosis, malignant hypertension, myocardial infarction, cerebrovascular accident, heart failure and other critical conditions within 6 months.? There have been serious infections in the near future (within 4 weeks). ? Patients with serious primary diseases such as heart, liver, brain, kidney and hematopoietic system, cancer and mental illness.? Women who are pregnant or preparing for pregnancy or breastfeeding. ? People with known allergy to Chinese medicine and severe allergy. ?Patients who have participated in other clinical drug trials within the last 3 months.? Those who do not know enough about this study, do not want to participate, or have poor compliance.?Not the author (can not cooperate with the diet control, or does not follow the prescribed medication and affect the efficacy of the judgment).

Design outcomes

Primary

Measure	Time frame
TCM symptom score;Diabetes incidence;Prediabetes reversal rate;Improvement rate of clinical efficacy;	—

Secondary

Measure	Time frame
Fasting plasma glucose;Postprandial blood glucose;Glycated albumin;Glycosylated hemoglobin;Fasting insulin;Total cholesterol;Triglyceride;Low density lipoprotein cholesterol;High density lipoprotein cholesterol;	—

Countries

CHINA

Contacts

Public ContactGao Hui-juan

Tsinghua University Yuquan Hospital (Tsinghua University Hospital of Integrated Chinese and Western Medicine)

987202931@qq.com+86 130 0124 9259

Outcome results

None listed

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