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Clinical effect of Baihu and Renshen Decoction on diabetic ketosis and diabetic ketoacidosis

A multicenter, randomized, double-blind, placebo-controlled clinical study of Baihu and Renshen Decoction on diabetic ketosis and diabetic ketoacidosis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027312
Enrollment
Unknown
Registered
2019-11-08
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-11-11

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

Conditions

Diabetic ketosis and Diabetic ketoacidosis

Interventions

Sponsors

Shenzhen Tradictional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnosis of diabetic ketosis and diabetic ketoacidosis in the Chinese hyperglycemic crisis diagnosis and treatment guidelines formulated by the diabetes branch of the Chinese Medical Association in 2013; 2. It conforms to the diagnosis of deficiency of yin and excessive heat syndrome of diabetes in the clinical research guide of new Chinese medicine; 3. Aged >= 16 and < 70 years; 4. Not participated in any intervention clinical research in the past 3 months; 5. Informed understanding of this study, and voluntarily signed a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Ketosis and ketoacidosis caused by hunger ketosis, alcohol ketoacidosis and other reasons; 2. Metabolic acidosis caused by serious infection, chronic kidney disease, renal tubular acidosis and other reasons; 3. Hyperlactatemia and acidosis caused by any reason; 4. Hypertonic state caused by high fever, sweating, gastrointestinal fluid loss, renal diabetes insipidus, water source disconnection, thirst disorder, dysphagia and other reasons; 5. Serious chronic diabetic complications: diabetic nephropathy state in G3aA2 and above, severe nonproliferative and proliferative retinopathy, diabetic lower extremity angiopathy ABI less than or equal to 0.9 or Fontaine's stage IIA and above, diabetic foot, etc; 6. Uncontrolled hypertension, systolic blood pressure > 160mmHg and / or diastolic blood pressure > 100mmHg; 7. Chronic kidney disease: eGFR 133 µ mol / L (1.5mg / dl); serious liver function abnormality (liver enzyme > 3uln; coagulation function abnormality; bilirubin abnormality); serious heart function abnormality: heart failure (above NYHA III), myocardial infarction, arrhythmia, etc.; acute stage of cerebrovascular disease; 8. Malignant diseases under treatment or not completely relieved or cured; 9. Pregnant or lactational period women; 10. Allergic to any ingredients in Baihu and Renshen Decoction; 11. The researcher thinks it is not suitable to participate in the study (mental or psychological state, etc.).

Design outcomes

Primary

MeasureTime frame
Urine ketone;Blood ketone;Blood Gas Analysis;

Countries

China

Contacts

Public ContactLiu Xuemei

Shenzhen Tradictional Chinese Medicine Hospital

88533198@qq.com+86 13622399200

Outcome results

None listed

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