Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances
NCT04623567 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2023-09-18
Summary
This study is a randomized, positive drug parallel-controlled clinical trial in participants with glucose and lipid metabolism disturbances. A total of 96 participants will be recruited for the study, all of whom are diagnosed as type 2 diabetes mellitus combined with dyslipidemia. The subjects will be divided randomly into two groups and treated with either Jiangtang Tiaozhi Recipe or metformin. After 12 weeks of treatment, therapeutic effect of Jiangtang Tiaozhi Recipe will be evaluated based on the changes of HbA1c, fasting blood glucose, postprandial blood glucose, blood lipid, waist circumference, body mass index.
Conditions
- Type2 Diabetes
- Dyslipidemias
Interventions
- DRUG
-
Jiangtang Tiaozhi recipe
The Jiangtang Tiaozhi recipe is a combination of several Chinese herbs, which has been granted a patent (No. ZL 2013 1 0373659.7)
- DRUG
-
The metformin tablets (500mg) will be administrated.
Sponsors & Collaborators
-
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
lead OTHER
Principal Investigators
-
Jiaxing Tian, PhD · Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-22
- Primary Completion
- 2023-12-30
- Completion
- 2024-06-30
Countries
- China
Study Locations
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