Clinical efficacy of Shutiao Wentang Pinghan decoction in patients with obstructive sleep apnea syndrome and type 2 diabetes

Clinical efficacy and Mechanism of Shutiao Wentang Pinghan decoction in patients with obstructive sleep apnea syndrome and type 2 diabetes

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400089179

Enrollment

Unknown

Registered

2024-09-03

Start date

2024-03-15

Completion date

Unknown

Last updated

2024-09-09

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

Conditions

obstructive sleep apnea syndrome and type 2 diabetes

Interventions

control group:lifestyle intervention, previous anti-diabetic, lipid-lowering and anti-hypertensive drugs

experimental group:Shutiao wentang pinghan decoction with lifestyle intervention, previous anti-diabetic, lipid-lowering and anti-hypertensive drugs

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of type 2 diabetes and obstructive sleep apnea ; (2) meet the standard of phlegm-dampness-heat type TCM syndrome ; (3) Aged between 20 and 70; (4) Hemoglobin A1C =6.5% ~ 10%; (5) Apnea hypopnea index =5 ~ 30 times /h; (6) Sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with serious primary diseases of the heart, brain, liver, kidney, hematopoietic system, serious coagulation mechanism disorders, mental diseases, and intellectual disabilities; (2) Patients with acute diabetic complications such as diabetic ketoacidosis, or chronic diabetic complications such as diabetic nephropathy (stage IV to V), diabetic retinopathy (stage IV to VI), and diabetic cardiomyopathy (NYHA grade III or above); (3) those currently using or planning to use insulin therapy; (4) in the pregnancy or breastfeeding period, or plan to become pregnant within 6 months; (5) Mixed or central sleep apnea; (6) hypothyroidism; (7) Those who have taken sedative hypnotic or muscle relaxation drugs in the past 3 months; (8) People who are known or likely to be allergic to the test Chinese medicine ingredients; (9) Participants in other clinical trials within the last 3 months.

Design outcomes

Primary

Measure	Time frame
Apnea hypopnea index;hemoglobin A1c;	—

Secondary

Measure	Time frame
deoxygenation index;lowest arterial oxygen saturation;percentage of total sleep time with oxygen saturation <90%;fasting plasma glucose;2-h post-load glucose ;fasting insulin;homeostasis model assessment of insulin resistance;triglyceride;total cholesterol;low-density lipoprotein cholesterol ;high-density lipoprotein cholesterol ;Epworth sleepiness scale;Pittsburgh Sleep Quality index;visceral adipose tissue area;subcutaneous adipose tissue area;body mass index;waist hip ratio;	—

Measure

Time frame

deoxygenation index;lowest arterial oxygen saturation;percentage of total sleep time with oxygen saturation <90%;fasting plasma glucose;2-h post-load glucose ;fasting insulin;homeostasis model assessment of insulin resistance;triglyceride;total cholesterol;low-density lipoprotein cholesterol ;high-density lipoprotein cholesterol ;Epworth sleepiness scale;Pittsburgh Sleep Quality index;visceral adipose tissue area;subcutaneous adipose tissue area;body mass index;waist hip ratio;

—

Countries

China

Contacts

Public ContactChan ka kei; Piao Chunli

Guangzhou University of Chinese Medicine Shenzhen Hospital (Futian)

luciachankk@qq.com+86 166 2052 8492

Outcome results

None listed

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