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A prospective, randomized controlled clinical study on the treatment of hypoproteinemia with black bean granule

A prospective, randomized controlled clinical study on the treatment of hypoproteinemia with black bean granule

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062731
Enrollment
Unknown
Registered
2022-08-16
Start date
2022-08-15
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

hypoproteinemia

Interventions

Experimental group:Take two packets of black bean granules twice a day
The control group:Take two packs of simulant granules twice a day

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria of Western medicine for stage 1-3 chronic kidney disease; 2. Meet the syndrome differentiation criteria of spleen deficiency damp-heat syndrome of traditional Chinese medicine edema disease; 3. 20g/L<= serum albumin <= 30g/L, 24-hour urinary protein <= 8g/24h; 4. According to the relevant guidelines for more than 3 months of standard treatment, 20g/L<= serum albumin <= 30g/L; 5. Age 18-75, both gender and ethnicity; 6. Patients who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe hydrothorax and abdomen, hydrothora > 500ml or ascites > 1000 ml; 2. Rapidly progressive CKD(monthly increase of Scr > 20%, doubling of serum creatinine, entering dialysis); 3. Severe cardiac insufficiency, cardiac function grade III-IV; 4. Patients with other diseases leading to hypoproteinemia, such as liver disease, tumor, malnutrition; 5. Patients with malignant tumors or a history of malignant tumors, HIV infection, mental illness, acute central nervous system diseases, and severe gastrointestinal diseases; 6. Pregnant or lactating women; 7. Being investigated in other clinical trials;

Design outcomes

Primary

MeasureTime frame
serum albumin;

Secondary

MeasureTime frame
24-hour urinary protein;TCM syndrome integration;

Countries

China

Contacts

Public ContactLin Wang

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

happytlynn@163.com+86 13585614134

Outcome results

None listed

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