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Clinical epidemiology investigation of type 2 diabetes mellitus with Yin deficiency syndrome

Study on syndrome differentiation standard of yin deficiency syndrome in type 2 diabetes mellitus

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049926
Enrollment
Unknown
Registered
2021-08-12
Start date
2021-02-04
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Type 2 diabetes mellitus

Interventions

Type 2 diabetes mellitus patients with Yin deficiency syndrome:None
Type 2 diabetes mellitus with non Yin deficiency syndrome (phlegm dampness syndrome) group:None

Sponsors

Dongzhimen Hospital of Beijing University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
27 Years to 69 Years

Inclusion criteria

Inclusion criteria: The classification standard of glycometabolism and the diagnostic criteria of different stages of type 2 diabetes were adopted in China. The international diagnostic and classification standard applied in the guideline for prevention and treatment of type 2 diabetes (2017 Edition) was also applied to the WHO (1999) standard. Chinese medicine diabetes syndrome Yin deficiency syndrome differentiation standard reference 1992 China Association of Chinese medicine Medical Association Diabetes Disease Specialized Committee "diabetes mellitus" TCM staging syndrome differentiation and curative effect evaluation standard (attached) diabetes diagnosis and reference standard. Specific inclusion criteria are: 1. Clear diagnosis is consistent with pre diabetes (including impaired fasting glucose and impaired glucose tolerance) and type 2 diabetes. ? TCM syndrome differentiation has Yin deficiency syndrome (fear of hot sweating or night sweating, hand and foot heart or five heart upset heat, thin red tongue and crack, thin pulse, with 2 items that can be diagnosed); ? TCM syndrome differentiation has non Yin deficiency syndrome (phlegm dampness syndrome) (A. chest tightness, or with epigastric and abdominal stuffiness, or suffocation in pharynx, or unfavorable expectoration, or vomit evil phlegm; b. Obesity; c. Dizziness, heavy head, or heavy limbs; d. The tongue coating is white and greasy; e. The pulse is slippery or moist. If it has items a-b2, or any item plus any item C-E, it can be judged.); ? No serious diseases such as heart, brain, liver and kidney; ? Persons aged between 18 and 70; ? Those who voluntarily participate in and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria refer to the criteria for excluding cases (including indications of non compliance or exclusion criteria) in the guiding principles for clinical research of new drugs in Chinese medicine (2002 Edition). Patients with type 1 diabetes or other special types of diabetes mellitus; ? At baseline, HbAlc > 8.5%; ? At baseline, blood pressure 160 / 100mmhg; ? At baseline, ALT or AST = 1.5 times the upper limit of normal reference value, or hemoglobin = 90g / L; (5) patients with acute infectious diseases, chronic hepatitis B, active phase and delayed liver cirrhosis, decompensated cirrhosis, active tuberculosis, heart failure, cardiovascular accident, trauma, surgery, urinary tract obstruction, renal artery stenosis, congenital malformation of kidney, nephrectomy, etc. ? Patients with unstable basic treatment of reducing blood glucose, blood pressure and blood lipid in recent 3 months ? patients who have used or currently need systemic hormone, immunosuppressant or renal replacement therapy in recent 3 months; ? Patients with serious primary diseases such as heart, brain, lung, liver, nervous system and hematopoietic system; There was a history of diabetic ketoacidosis in the past six months. He had previously suffered from diabetic hyperosmolar coma or other acute diabetic complications. ? Patients with mental retardation or mental illness; ? Pregnant and lactating women; ? The investigator considers it inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose;Blood glucose 2 hours after meal;HbA1C;Universal syndrome differentiation standard scale of yin deficiency syndrome;Syndrome differentiation scale of type 2 diabetes mellitus with Yin deficiency syndrome;Observation table of intelligent auxiliary diagnosis system for tongue diagnosis of traditional Chinese medicine (ds01-g);Data acquisition table of eye image health imager (meyed-10);

Secondary

MeasureTime frame
Biochemical term;Tumor markers;Routine blood test;Urinalysis;Stool routine;Coagulation function test;Myocardial injury markers;BNP;Thyroid function;Fasting insulin level;Fasting C-peptide;Diabetes antibody spectrum;

Countries

China

Contacts

Public ContactWang Shidong

Dongzhimen Hospital of Beijing University of traditional Chinese Medicine

wsd3122@126.com+86 13910965659

Outcome results

None listed

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