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Clinical Research on the Improvement of Phlegm-Dampness Obesity with Impaired Glucose Regulation Using Sanren Douling Meal Replacement

Clinical Research on the Improvement of Phlegm-Dampness Obesity with Impaired Glucose Regulation Using Sanren Douling Meal Replacement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001396
Enrollment
Unknown
Registered
2025-07-12
Start date
2025-07-15
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

obesity with impaired glucose regulation

Interventions

Control group:Konjac flour meal replacement
Experimental Group:Sanren Douling Meal Replacement

Sponsors

xiyuan hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) 18 years = Age = 65 years gender not limited; (2) Meets the diagnostic criteria for obesity and impaired glucose regulation; (3) Meets the criteria for phlegm-dampness constitution according to the "Classification and Determination of Constitution in Traditional Chinese Medicine"; (4) The subject voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Combined with hepatic and renal insufficiency (liver function ALT and/or AST greater than 1.5 times the upper limit of normal renal function CR greater than the upper limit of normal) severe cardiovascular and cerebrovascular diseases hematopoietic system diseases mental illness and other comorbidities. (2) Women with fertility requirements in the past six months pregnant women or breastfeeding women. (3) Those with mental abnormalities or poor compliance. (4) Individuals with allergic constitution or known allergy to the study drugs. (5) Those taking Western medications such as metformin and acarbose as well as Chinese patent medicines with hypoglycemic effects. (6) Patients who have received treatment with Chinese or Western weight-loss drugs or participated in other drug clinical trials within the past 3 months.

Design outcomes

Primary

MeasureTime frame
Changes in BMI after 8 weeks of treatment;Changes in fasting blood glucose levels after 8 weeks of treatment;Changes in blood glucose levels 2 hours after meals for 8 weeks of treatment;

Secondary

MeasureTime frame
body fat percentage;Insulin resistance related indicators ( adiponectin fasting insulin insulin resistance index );Waist circumference and waist-to-hip ratio;Phlegm dampness constitution conversion points;Lipid-related levels ( total cholesterol triglyceride low-density lipoprotein cholesterol high-density lipoprotein cholesterol );fatigue self-assessment scale;Proportion of changes in impaired glucose regulation;

Countries

China

Contacts

Public ContactWang Peili

xiyuan hospital China Academy of Chinese Medical Sciences

shengjingtcm@163.com01062835134

Outcome results

None listed

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