Latent tuberculosis infection
Conditions
Interventions
Phlegm-Heat syndrome control group:Twice weekly, each time Isoniazid (maximum dose 600mg) combined with Rifapentine (maximum dose 600mg), orally. Duration: 3 months.
Phlegm-Heat Interconnection Syndrome Trial Group:In addition to the treatment measures of the control group, Tan Re Qing capsules were administered, with 3 capsules each time, twice a week, orally, fo
Qi and Yin Deficiency Syndrome Control Group:Twice weekly, each time Isoniazid (maximum dose 600mg) combined with Rifapentine (maximum dose 600mg), orally. Duration: 3 months.
Qi and Yin Deficiency Syndrome:In addition to the control group's treatment measures, add the use of Biejiaojin tablets, 5 tablets each time, twice a week, taken orally, for a 3-month course.
Sponsors
Lishui City Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 59 years old; (2) Confirmed as a close contact of a patient with rifampicin-sensitive active pulmonary tuberculosis through epidemiological investigation; (3) Meets the above diagnostic criteria for latent tuberculosis infection (LTBI); (4) Meets the above criteria for TCM syndrome differentiation and classification (qi and yin deficiency syndrome or phlegm-heat intermingling syndrome); (5) Voluntarily participates and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Confirmed or suspected active tuberculosis; (2) Pregnancy, lactation, or planning to become pregnant; (3) History of continuous use of isoniazid for =30 days or continuous use of rifamycin antibiotics for =14 days within 2 years prior to enrollment; (4) Allergy to the study drugs or their components; (5) Current use of medications that have significant interactions with the study drugs; (6) Alcohol dependence; (7) Abnormal liver function (ALT or AST = 3 × upper limit of normal, total bilirubin = 2.5 × upper limit of normal), liver cirrhosis, or active viral hepatitis; (8) Severe hematologic disorders (e.g., ANC < 0.75 × 10*9/L, PLT < 50 × 10*9/L, Hb < 70 g/L); (9) Clinically significant arrhythmias with QTc interval = 450 ms; (10) Neurological and psychiatric diseases (e.g., uncontrolled epilepsy, schizophrenia, etc.); (11) Peripheral neuropathy of grade = 2 (CTCAE version 5.0); (12) Body weight < 40 kg; (13) People living with HIV (HIV-infected individuals).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chest X-ray;Tuberculosis smear, Tuberculosis culture; | — |
Secondary
| Measure | Time frame |
|---|---|
| Suspected tuberculosis symptoms; | — |
Countries
China
Contacts
Public ContactZhang Zunjing
Lishui City Traditional Chinese Medicine Hospital
Outcome results
None listed