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A Cohort study to explore the effect oftraditional Chinese medicineintegratedwiththewesternmedicineon diabetes mellitus and its chronic complications

A Cohort study to explore the effect oftraditional Chinese medicineintegratedwiththewesternmedicineon diabetes mellitus and its chronic complications

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090153
Enrollment
Unknown
Registered
2024-09-25
Start date
2024-09-30
Completion date
Unknown
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes and its chronic complications

Interventions

Chinese Medicine Exposure Group (Chinese herbal medicine is given according to the patients dialectical situation):None
Non-herbal exposure group (Conventional Western Medicine):None

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the retrospective cohort (1) Age 35-75 years old; (2) Meet the diagnostic criteria for type 2 diabetes mellitus (Type 2 diabetes Mellitus) in the 2020 China Diabetes Prevention and Control Guidelines; (3) Detailed medical history of the patients, complete medical records and medical prescriptions of the central hospital where the study was conducted. (4) Agree to participate and cooperate with the survey and sign the informed consent form. Inclusion criteria of the prospective cohort (1) Age 35-70 years old; (2) Meet the diagnostic criteria of type 2 diabetes mellitus (Type 2 diabetes Mellitus) according to the 2020 China Diabetes Prevention and Control Guidelines; (3) The duration of diabetes mellitus was>=5 years, and there were no clear chronic complications of diabetes mellitus such as diabetic peripheral neuropathy, diabetic retinopathy, diabetic nephropathy, and so on at the time of enrollment; (4) The patient has a fixed place of residence and occupation, can provide detailed contact information, and has no short-term relocation. (5) Agree to participate and cooperate in the follow-up visit and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria for the retrospective cohort (1) Acute cerebrovascular disease, acute cardiovascular disease attack; (2) Mental illness, unable to cooperate with the survey; (3) People undergoing chemotherapy for malignant tumors (chemotherapy drug-related peripheral neuropathy). (4) Other diseases causing peripheral neuropathy(e.g., connective tissue disease, severe renal insufficiency with eGFR less than 30 mL/min/1.73 m2). Exclusion Criteria for Prospective Cohort (1) Acute cerebrovascular disease, acute cardiovascular disease attack; (2) Diseases that may cause serious shortening of life expectancy (including but not limited to: uncontrolled malignant tumors, etc., severe heart failure New York Heart Association,NYHA Class IV). (3) Severe renal insufficiency (eGFR less than 30 mL/min/1.73m2); (4) Acute complications of diabetes mellitus, such as ketoacidosis, hyperosmolar coma, severe hypoglycemic coma, etc; (5) Stress, such as trauma, perioperative period, acute stage of severe infection, etc. (6) Serious mental and neurological diseases, communication disorders affecting the evaluation of cognitive function, inability to properly express their wishes, depression with suicidal tendency. (7) Alcoholism, drug addiction (8) Patients with other co-morbidities who, in the opinion of the investigator, will not be evaluated for efficacy or are unlikely to complete the expected course of treatment and follow-up.The following are examples of patients who may be eligible for the program.

Design outcomes

Primary

MeasureTime frame
Temperature sense;Feet sensation;Vibration sensation;Ankle reflex;Nerve conduction velocity;Global deteriorate scale;Mattis dementia rating scale;Serum creatinine;Albuminuria;Fundus examination;

Secondary

MeasureTime frame
Michigan Diabetic Neuropathy Score;Toronto clinical scoring system;Mini mental status examination;Montreal cognitive assessment;Alzheimer disease assessment scale- cog;Activity of Daily Living;

Countries

China

Contacts

Public ContactTian Guoqing

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

gq-Tian@163.com+86 186 1267 1985

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026