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Buyuan-zhixiao Formula in the Treatment of Elderly Patients With Diabetes and Multiple Metabolic Disorders

Aging Clinical Trial

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

Clinical Trial 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;

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06358118
Study type Interventional
Source Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact Qing Ni, postgraduate
Phone 13701253942
Email 1831479145@qq.com
Status Not yet recruiting
Phase N/A
Start date May 6, 2024
Completion date July 1, 2025
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