NCT06358118

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Qing Ni · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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;

Conditions

• Diabete Mellitus
• Aging
• Metabolic Disorders
• Traditional Chinese Medicine
• Randomized Controlled Trial

Interventions

Type	Name	Description
DRUG	Buyuan Zhixiao Formula	Buyuan Zhixiao Formula
DRUG	Placebo	The placebo contains 10% of the active ingredients of the Chinese medicine group

Timeline

• Start date: 2024-07-06
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2024-04-10
• Last updated: 2024-06-04

Locations

6 sites across 1 country: China