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Clinical observation of Xiaoke Pill combined with Daglipzin in treatment of type 2 diabetes mellitus with metabolic syndrome

Clinical observation of Xiaoke Pill combined with Daglipzin in treatment of type 2 diabetes mellitus with metabolic syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090109
Enrollment
Unknown
Registered
2024-09-24
Start date
2023-08-01
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

type 2 diabetes

Interventions

Experimental group:The experimental group was given dagaglizin 10mg/ time, once /d, plus Xiaoke pill, the initial oral dose of Xiaoke pill was 5 pills/time, 3 times a day, and the adjustment was made
control group:Daglipzin 10mg/ time, once/day. Treatment for 12 weeks. The dose of daglizin remained unchanged during the period.

Sponsors

Shaowu Municiple Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? Meet the Western medicine diagnostic criteria for patients with type 2 diabetes mellitus combined with metabolic syndrome, and can be diagnosed with 3 or more of the following (B is necessary); A. Abdominal obesity (that is, central obesity) : waist circumference =90 cm for men and =85 cm for women. B. Hyperglycemia: fasting blood glucose = 6.1mmol /L or blood glucose = 7.8mmol /L 2 h after glucose loading and (or) have been diagnosed with diabetes and treated. C, hypertension: blood pressure =130/85 mmHg (1 mmHg=0.133 kPa) and/or have been recognized as hypertension and treated. D. Fasting triglyceride (TG) =1.70 mmol/L. E, fasting HDL-C< 1.04mmol /L. ? Consistent with Qi-Yin deficiency syndrome; Main symptoms: fatigue, dry throat, dry mouth, frequent urination, frequent urination at night. Secondary symptoms: easy hunger, thirst, shortness of breath, lazy talk, upset, hot hands and feet, hyperhidrosis, spontaneous sweating, night sweats, palpitation, insomnia, redness, constipation. Tongue and pulse: the tongue is red and less fluid, the fur is thin or the flower is peeled, and the pulse is weak or thin and string. ? Age 18-75 years old; ? Normal mental and conscious state; ? Sign informed consent.

Exclusion criteria

Exclusion criteria: ? History of serious infection or major surgery within the last 3 months; ? Pregnant or lactating women; ?Type 1 diabetes mellitus; ? dysfunction of vital organs (heart, brain, liver, kidney, etc.); ? There is a history of drug allergy or multiple food allergy; ? Patients with malignant tumor diseases, severe immune system diseases, cognitive dysfunction diseases, pathological obesity; ? Contraindications of Xiaoke pills and dagliagin.

Design outcomes

Primary

MeasureTime frame
FPG;2h PG;HbA1c;TC;TG;LDL-C;HDL-C;SBP;DBP;CRP;PCT;UACR;MALB;Scr;BUN;

Secondary

MeasureTime frame
DSQL;TCM symptom score;

Countries

China

Contacts

Public ContactMao Caifeng

Shaowu Municiple Hospital

1013772574@qq.com+86 151 0277 2281

Outcome results

None listed

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