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The effect of Liu Wei Di Huang Capsule on type 2 diabetes mellitus with Yin deficiency: a multiple-centered clinical study

The effect of Liu Wei Di Huang Capsule on type 2 diabetes mellitus with Yin deficiency: a multiple-centered clinical study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006723
Enrollment
Unknown
Registered
2022-10-31
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-02-20

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

treatment group:Basic treatment + Liu Wei Di Huang Capsules taken orally
control group:Basic treatment + simulators of Liu Wei Di Huang Capsules taken orally

Sponsors

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ?Patients with a clear diagnosis of type 2 diabetes or those who meet the Western diagnostic criteria for type 2 diabetes. ? glycated haemoglobin <9.0%. ?Possessing yin deficiency evidence as identified by Chinese medicine. ?Age 18-75 years old (including 18 and 75 years old), regardless of gender. ? Those who voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: ? Patients with type 1 diabetes or other specific types of diabetes. ? HbAlc = 9.0% at baseline. ? Those with blood pressure 160/100mmHg at baseline. ? ALT or AST = 1.5 times the upper limit of normal reference value at baseline; eGFR <45mL/min/1.73m2; ? Patients with acute infectious diseases, active or extended chronic viral hepatitis B, cirrhosis, active tuberculosis, heart failure, cardiovascular accidents, trauma, surgery, etc. (6) Patients with dry syndrome, pulmonary tuberculosis, thyroid or adrenal diseases, long-term use of glucocorticoids and other diseases that may lead to yin deficiency. ? Patients with a combination of serious primary diseases such as heart, brain, lung, liver, nervous system and haematopoietic system. ? Patients with a history of diabetic ketoacidosis, diabetic hyperosmolar coma or other acute complications of diabetes mellitus within 3 months. ? Patients with mental retardation or psychiatric disorders. ? Females who are pregnant or breastfeeding, or have an intention to become pregnant, or have a positive pregnancy test (measuring urine HCG or blood HCG). ? Patients who, in the opinion of the investigator, are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
FBG;TCM Evidence Score;2hPG;Hba1c;

Secondary

MeasureTime frame
C-P;GA;INS;

Countries

China

Contacts

Public ContactShidong Wang

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, China

wsd3122@126.com13910965659

Outcome results

None listed

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