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Clinical study of Jiedu Tongluo Tiaogan formula regulating biological clock in treatment of type 2 diabetes mellitus patients

Clinical study of Jiedu Tongluo Tiaogan formula regulating biological clock in treatment of type 2 diabetes mellitus patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086103
Enrollment
Unknown
Registered
2024-06-25
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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:On the basis of conventional western medicine treatment, Jiedu Tongluo Tiaogan formula is added to intervene
control group:Conventional Western medicine treatment, including basic treatment (diabetes education, diet control, strengthening exercise, smoking cessation and alcohol restriction and other lifestyl

Sponsors

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of T2DM in Western medicine; (2) Conforming to the TCM standard of liver-stomach stagnation heat syndrome differentiation; (3) Hemoglobin a1C (HbA1c) =10%; (4) Age between 18 and 75 years old, gender is not limited; (5) The observed voluntarily participated in the subject and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Those who have a history of drug allergy and allergic constitution in this study; (2) Women planning to become pregnant, pregnant or breastfeeding; (3) Patients who have recently experienced various acute infections, acute diabetic complications and diabetic foot gangrene (co-infection); (4) People with mental disorders, serious diseases of the heart, liver, kidney, brain, blood vessels and other systems or with other serious diseases; (5) Chronic colitis, spleen and stomach deficiency cold; (6) Patients who have participated in other clinical studies in the past 3 months.

Design outcomes

Primary

MeasureTime frame
24-hour dynamic blood glucose monitoring;

Secondary

MeasureTime frame
Munich ChronoType Questionnaire;melatonin;Sleep, heart rate, exercise, and other physical activity records;FBG;HbA1c;FINS;HOMA-IR;TC;TG;LDL;HDL;BMI;WHR;Total score of TCM syndrome;

Countries

China

Contacts

Public ContactChunli Piao

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)

pcl2013@sina.cn+86 188 1907 5590

Outcome results

None listed

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