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

NCT06358118 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-06-04

No results posted yet for this study

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

DRUG

Buyuan Zhixiao Formula

Buyuan Zhixiao Formula

DRUG

Placebo

The placebo contains 10% of the active ingredients of the Chinese medicine group

Sponsors & Collaborators

  • Qing Ni

    lead OTHER

Principal Investigators

  • Qing Ni, postgraduate · China Academy of Chinese Medical Sciences Guang'anmen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-06
Primary Completion
2025-07-01
Completion
2025-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06358118 on ClinicalTrials.gov