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A randomized, controlled, multi-center clinical trial to evaluate the effectiveness and safety of Yujieli in the nutritional support treatment of patients with newly treated active pulmonary tuberculosis and malnutrition

A randomized, controlled, multi-center clinical trial to evaluate the effectiveness and safety of Yujieli in the nutritional support treatment of patients with newly treated active pulmonary tuberculosis and malnutrition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101532
Enrollment
Unknown
Registered
2025-04-25
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Tuberculosis

Interventions

Experimental group:Anti-tuberculosis treatment + regular diet + Yu Jieli(three months)
Control group:Anti-tuberculosis treatment + regular diet

Sponsors

Shenyang Jinzhilu Medical Technology Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old, gender is not limited; 2. Treatment-naïve sensitive pulmonary tuberculosis patients (bacteriology, molecular biology) with clinical diagnosis that meet the diagnostic criteria for pulmonary tuberculosis WS288-2017; 3. Patients who are diagnosed with moderate to severe malnutrition and assessed by GLIM malnutrition according to the Nutritional Risk Screening Form (NRS-2002) with a score of = 3 points; 4. Patients who have not received anti-tuberculosis therapy before, or who have been treated for less than 1 week; 5. Patients who can take oral enteral nutrition supplements throughout the course; 6. The clinical study participant has given informed consent, voluntarily participated in this study, and has good treatment compliance, and has signed the informed consent form of the clinical study participant.

Exclusion criteria

Exclusion criteria: 1. Combined with extrapulmonary tuberculosis and other serious comorbidities 1. Patients with extrapulmonary tuberculosis and tuberculous pleurisy; 2. Patients with diabetes mellitus; 3. Patients with epilepsy and psychiatric disorders; 4. Combined with severe organic cardiovascular and cerebrovascular diseases (such as congestive heart failure, myocardial infarction, acute stroke, etc., which are classified as NYHA cardiac function grade III.-IV); 5. Combined with severe liver and kidney diseases, or abnormal liver and kidney function tests (ALT, AST> = 2.5 times the upper limit of normal, GFR <60ml·min^-1·1.73 m^-2); 6. Combined with intestinal obstruction; 2. Nutrition-related issues 1. Those who are known or suspected to be allergic to protein, manifested by skin redness and swelling, frequent diarrhea, etc.; 2. People with hepatic coma and pre-hepatic coma, uremia, abnormal protein metabolism, such as phenylketonuria, organic acid disease, urea cycle metabolism disorder, etc.; 3. Patients who received nutritional therapy or immunotherapy 4 weeks prior to enrollment; 3. Miscellaneous 1. Pregnant, lactating women; 2. HIV infection; Syphilis antibody positive patients; 3. Those who participate in other clinical trials at the same time; 4. Those who suspect or do have a history of alcohol or drug abuse or drug dependence tendency; 5. Patients who are considered by the investigator to be unsuitable for inclusion in this trial.

Design outcomes

Primary

MeasureTime frame
Treatment success rate;

Secondary

MeasureTime frame
Sputum yin rate;Sputum bacteria yin time;Imaging improvement;

Countries

China

Contacts

Public ContactZeng Yi

The Second Hospital of Nanjing

960559051@qq.com+86 136 0158 6598

Outcome results

None listed

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