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To explore the regulatory mechanism of Gulao Decoction on bone tuberculosis immune disorder and liver damage based on Th17 / Treg balance

Regulatory mechanism of Gulao Decoction on bone tuberculosis immune disorder and liver damage

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005817
Enrollment
Unknown
Registered
2022-04-06
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Bone tuberculosis

Interventions

control group: standard anti tuberculosis
Test group:Gulao Decoction + standard anti tuberculosis

Sponsors

Nanjing Integrated Traditional Chinese and Western Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 78 Years

Inclusion criteria

Inclusion criteria: ? Meet the diagnostic criteria; ? In line with liver and kidney deficiency syndrome; ? Aged from 20 to 80 years old, regardless of gender; ? The subjects or their families gave informed consent and signed the informed consent form. The process of obtaining informed consent shall comply with the provisions of GCP. Diagnostic criteria: refer to practical orthopaedics (4th Edition): ? general symptoms: most patients have low fever, night sweats, loss of appetite, weight loss, dull pain at the onset of tuberculosis, and some serious patients may have intercostal neuralgia, lower limb neuralgia or paraplegia; ? Signs: local swelling, high skin temperature, or sinus pus, tenderness, scoliosis or kyphosis, positive bending and picking up test. ? Laboratory examination: blood routine examination can indicate anemia, increased ESR and C-reactive protein, positive T cell result of tuberculosis infection and positive tuberculosis antibody; ? Imaging examination: on the X-ray film, the main manifestations are bone destruction at the upper and lower edges of the vertebral body and intervertebral space stenosis. Some patients are complicated with psoas major cold abscess. On the X-ray film, the shadow of psoas major is blurred, widened, plump or localized bulge. CT showed wormhole like cavity or dead bone, paravertebral or psoas abscess. Abnormal signals of local inflammatory infiltration can be seen on MRI in the early stage, and spinal cord compression and degeneration can be seen in the middle and late stage. ? If it is difficult to diagnose, puncture biopsy can be performed: pathology or pus gene test (X-port). According to ?, ? or ? + ? + ?, it is diagnosed as bone tuberculosis. Bone tuberculosis liver and kidney deficiency syndrome: main symptoms: ? chills; ? Spontaneous and night sweats; ? Poor appetite and weight loss; ? Palpitation and sleeplessness; ? Dull and weak complexion; Secondary symptoms: ? continuous discharge of pus; ? Don't shut up for a long time; ? Local skin color is red; Tongue pulse: ? light red tongue; ? White fur; ? Pulse number or imaginary number; With 2 main symptoms and 1 secondary symptom, syndrome differentiation can be achieved by referring to the pulse of tongue coating.

Exclusion criteria

Exclusion criteria: ? Other types of bone tuberculosis were excluded; ? Relevant differential diagnosis diseases such as suppurative spondylitis, endplate inflammation, spinal tumor, ankylosing spondylitis and lumbar disc herniation were excluded; ? Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system were excluded; Exclude AIDS and other immunodeficiency diseases; ? Exclude mental diseases; ? Patients with severe allergic constitution.

Design outcomes

Primary

MeasureTime frame
AST;Urinary CTX-I;Th17/Treg;Urinary deoxypyridinoline;Related inflammatory factors;ALT;Urinary pyridinoline;

Countries

chain

Contacts

Public ContactRui Wang

Nanjing Integrated Traditional Chinese and Western Medicine Hospital

626833435@qq.com13912966161

Outcome results

None listed

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