Evaluating a Chinese herbal medicine for treating diabetes and lipid issues
Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances and Associations Study Between Glucose and Lipid Metabolism Disturbances and Cardiovascular Risk Factors
This study is testing if a Chinese herbal medicine can help people with type 2 diabetes and cholesterol problems feel better compared to a common diabetes medication.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04623567 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, controlled study assessing the efficacy of the Jiangtang Tiaozhi Recipe in participants with type 2 diabetes and dyslipidemia. A total of 96 participants will be randomly assigned to receive either the herbal treatment or metformin for 12 weeks. The study will evaluate changes in key health indicators such as HbA1c, fasting blood glucose, postprandial blood glucose, and lipid levels. The trial aims to determine if the herbal remedy can effectively improve metabolic disturbances compared to a standard medication.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 diagnosed with type 2 diabetes and dyslipidemia who have not achieved normal glucose and lipid levels through diet and exercise.
Not a fit: Patients with type 1 diabetes, gestational diabetes, or serious complications from diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an alternative treatment option for patients struggling with glucose and lipid metabolism disturbances.
How similar studies have performed: While the use of herbal medicine in diabetes management is explored, this specific approach with Jiangtang Tiaozhi Recipe is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 to 70 years at the time of their consent; 2. Diagnosed with type 2 diabetes; 3. TG≥1.7 mmol/L or LDL-C≥3.4 mmol/L; 4. BMI≥24.0 kg/m2 or male waist circumference≥90 cm, female waist circumference≥80 cm; 5. Failed to reach the normal standards of blood glucose and lipids after diet control and exercise therapy before enrollment; 6. TCM Syndrome differentiation as excess heat in the stomach and intestines syndrome; 7. Signed informed consent. Exclusion Criteria: 1. Type 1 diabetes, gestational diabetes, other special types of diabetes. 2. Diabetic complications were the main symptoms, that is, patients with serious heart, lung, liver, kidney, brain complications or other serious primary diseases. 3. Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month. 4. Have a history of serious gastrointestinal diseases, or are suffering from serious gastrointestinal diseases, such as peptic ulcer, gastrointestinal bleeding, gastroparesis, pyloric stenosis, gastric shunt, etc.. 5. Psychiatric patients, alcoholism and/or psychoactive substances, drug abusers and addicts. 6. Pregnant, preparing for pregnancy or lactation. 7. Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies. 8. According to the judgment of the researcher, other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment, are likely to cause loss of follow-up.
Where this trial is running
Beijing, Beijing
- Guang'anmen Hospital, China Academy of Chinese Medical Sciences — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Jiaxing Tian, PhD — Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Study coordinator: Jiaxing Tian, PhD
- Email: tina_yai@126.com
- Phone: +8601088001166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.