type 2 diabetes mellitus (qi and yin deficiency) related xerostomia
Conditions
Interventions
control group:Standard anti-T2DM therapy
experimental group:Yuquan capsules+Standard anti-T2DM therapy
Sponsors
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18 and 65 years old, gender is not limited; 2) Diagnosed with type 2 diabetes; 3) Diagnosis of qi and yin deficiency; 4) Unstimulated Whole Saliva (UWS) flow rate =1.5mL/15min; 5) Stabilization therapy for =3 months; 6) Those with stable glycemic control (6.5% = HbA1c = 8.0%) but still have xerostomia symptoms ; 7) Signed informed consent and voluntarily participated in this study.
Exclusion criteria
Exclusion criteria: 1) Those with severe acute or chronic complications of type 2 diabetes mellitus, or suffering from other major diseases; 2)Patients with xerostomia due to other diseases (e.g. Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, asthma, bronchitis, hepatitis C, etc.); 3)Patients treated with immunosuppressants, chloroquine, adrenocorticotropic hormones, and psychotropic drugs in the last 1 month; 4)Patients who have received herbal medicine, and/or other medications to relieve dry mouth within the last 1 month; 5)Patients with oral diseases such as periodontal disease, oral mucosal ulcers and patients with loose teeth; 6)Patients with a history of head and neck radiotherapy, organ transplantation, or use of a ventilator; 7)Patients who have participated in other clinical trial programs within 3 months prior to screening; 8)Patients who are pregnant or preparing for pregnancy and those who are breastfeeding; 9)Subjects who, in the opinion of the investigator, are unsuitable for enrollment for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in unstimulated Whole Saliva flow rate at week 12 of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in unstimulated Whole Saliva flow rate at week 4 and 8 of treatment;Change from baseline in score of Xerostomia Evaluation Scale at weeks 4, 8, and 12 of treatment;Clinical efficacy of TCM symptom score assessment at weeks 4, 8 and 12 of treatment;Change from baseline in water intake at week 12 of treatment;Change from baseline in fasting insulin, fasting C-peptide, glycosylated hemoglobin (HbA1C), and two-hour postprandial glucose (2hPG) at week 12 of treatment;Change from baseline in fasting glucose (FPG) at weeks 4, 8, and 12 of treatment;Change from baseline in lipid levels at week 12 of treatment;Change from baseline in levels of inflammation-related markers at week 12 of treatment;Change from baseline in serumADPN and LPS at week 12 of treatment;Change from baseline in serum AQP5 levels at week 12 of treatment as measured by ELISA; | — |
Countries
China
Contacts
Public ContactHaixiang Ni
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed