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Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders
Sponsor: Qing Ni
Summary
The primary objective of this clinical trial is to assess the clinical efficacy and safety of the Buyuan Zhixiao Formula in treating elderly patients with diabetes and multiple metabolic disorders exhibiting symptoms of renal deficiency and blood stasis. Furthermore, this study aims to intervene in high-risk factors to prevent arteriosclerosis and to investigate the clinical efficacy of the Buyuan Zhixiao Formula in the prevention and treatment of cognitive impairments. The main questions it aims to answer are: 1. What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity? 2. Can Buyuan Zhixiao Formula improve cognitive impairment in diabetes? Researchers compared Buyuan Zhixiao Formula with a placebo (a drug that looks similar but contains only 10% of the active ingredients) to see if the drug Buyuan Zhixiao Formula can treat elderly people with diabetes and multiple metabolic disorders. Participants will: 1. Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months;Follow-up for 6 months; 2. Check fasting blood sugar and 2-hour postprandial blood sugar every month; check HbA1c, blood lipids, vascular function, and cognitive impairment serum markers every 3 months; 3. Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events; 4. Urine and serum samples were collected before and after treatment;
Official title: Clinical Research on Evidence Based Traditional Chinese Medicine for Elderly Diabetes Based on State Target Theory-Buyuan Zhixiao Fang in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders: Study Protocol for a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-07-06
Completion Date
2025-07-01
Last Updated
2024-06-04
Healthy Volunteers
No
Conditions
Interventions
Buyuan Zhixiao Formula
Buyuan Zhixiao Formula
Placebo
The placebo contains 10% of the active ingredients of the Chinese medicine group
Locations (6)
China Academy of Chinese Medical Sciences Guang'anmen Hospital
Beijin, Beijing Municipality, China
Cangzhou integrative medicine hospital
Hebei, China
Hohhot Mongolian Traditional Chinese Medicine Hospital
Neimeng, China
Binzhou Traditional Chinese Medicine Hospital
Shandong, China
Yantai Baishi Traditional Chinese Medicine Hospital
Shandong, China
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, China