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A randomized, double-blind, placebo-controlled clinical study of diacerein in the treatment of obesity in adults

A randomized, double-blind, placebo-controlled clinical study of diacerein in the treatment of obesity in adults

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062908
Enrollment
Unknown
Registered
2022-08-23
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Obesity

Interventions

Intervention group:Diacerein and lifestyle intervention
Control group:Placebo and lifestyle intervention

Sponsors

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Fully understand this study and voluntarily sign informed consent; Willing to follow and able to complete all procedures of the trial; 2. Meet the diagnostic criteria of simple obesity; 3. Aged >= 18 years old, <= 60 years old, male or female; 4. No other relevant weight loss treatment within 6 months before treatment.

Exclusion criteria

Exclusion criteria: 1. Those who do not meet the above inclusion criteria; 2. Hypothyroidism, hypercortisolism, and other secondary obesity; 3. Pregnant or lactating women or nearly 6 months have a pregnancy plan; menstrual women are not excluded; 4. Suffering from severe cardiovascular and cerebrovascular diseases, liver and kidney system diseases, hematopoietic system diseases, mental illness, etc.; 5. Have a history of allergy to diacerein or anthraquinone derivatives; 6. Patients with diarrhea such as inflammatory bowel disease, intestinal obstruction or pseudo-obstruction, and patients with unknown causes of abdominal pain; 7. Vital signs, three major routines, liver and kidney function, electrolytes, thyroid dysfunction patients; 8. Participate in other clinical studies and received investigational drugs or device treatment; 9. Currently taking therapeutic drugs affect the treatment parameters (hypoglycemic drugs, such as metformin, DPP-4 inhibitors, GLP-1 receptor agonists, acarbose, sulfonylureas, glinides, thiazolidinediones, SGLT2 inhibitors, insulin, etc.; lipid-lowering drugs, such as statins, fibrates, ezetimibe, etc.); 10. Use of antibiotics, glucocorticoids, immunosuppressive agents 3 months before the study; 11. HbA1c > 6.5% and/or FBG >= 7 mmol/L and/or PBG (120 min) >= 11.1 mmol/L; plasma cortisol (8:00) > 441 nmol/L; 12. Patients cannot complete this study or fail to comply with the requirements of this study according to the investigator's judgment.

Design outcomes

Primary

MeasureTime frame
Body mass index;Weight;Waist circumference;

Secondary

MeasureTime frame
TCM syndrome score;Acanthosis nigricans score;Lifestyle score;Inbody related indicators;Glucose metabolism indicators;Lipid metabolism indicators;Transient elastography of liver;Three items of thyroid function;Plasma cortisol (8:00);Adipocytokine indicators;Inflammatory factor indicators;

Countries

China

Contacts

Public ContactWenbing Shang

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

wbshang@njucm.edu.cn+86 13915970481

Outcome results

None listed

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