Safety and Efficacy of Ear Acupuncture for Antituberculosis Drug-Related Nausea and Vomiting

University of Indonesia (UI)

Status: Enrolling

Conditions: Tuberculosis, Pulmonary

Treatments: Device: Sham Press Needle; Device: Press Needle

Study type: Interventional

Funder types: Other

Identifiers

NCT07271225

0215

Details and patient eligibility

About

This study will look at whether press-needle ear acupuncture can help lower nausea and vomiting caused by antituberculosis medicines in people with pulmonary tuberculosis. Nausea and vomiting are common side effects of tuberculosis treatment, and they can make people stop taking their medicines

When treatment is stopped too early, tuberculosis may not be cured and may become resistant to medicines.

Participants in this study will have nausea and vomiting related to their tuberculosis treatment. They will be randomly assigned to one of two groups. One group will receive press-needle ear acupuncture. The other group will receive a placebo version that looks similar but does not stimulate acupuncture points

Researchers will check nausea and vomiting scores before treatment, during treatment, and after treatment to see whether press-needle acupuncture works better than placebo and whether it is safe. Press-needle acupuncture may help reduce nausea and vomiting by affecting nerves and lowering certain chemicals that trigger these symptoms, and it has minimal side effects

If this method is proven helpful and safe, it may give patients a comfortable and low-risk way to manage nausea and vomiting during tuberculosis treatment

Enrollment: 58 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants are individuals diagnosed with drug-sensitive tuberculosis or drug-resistant tuberculosis receiving short-term treatment regimens (BPaL/BPaLM)
• Participants are aged 17 years or older.
• Participants experience nausea and vomiting after taking antituberculosis drugs.
• Participants are willing to comply with the study schedule until completion and provide written informed consent.

Exclusion criteria

• Presence of skin lesions at the site where press needles (PN) will be applied
• Participants who experience nausea and vomiting prior to antituberculosis treatment (including comorbidities that may cause nausea and vomiting, such as renal failure and liver disorders)
• Participants with drug-resistant tuberculosis (DR-TB) receiving long-term or individualized treatment regimens
• Participants with diabetes mellitus and a random blood glucose level > 200 mg/dL
• Participants with unstable hemodynamic status
• Participants who have received acupuncture therapy within the last 2 weeks
• Participants with coagulation disorders (platelet count < 50,000/µL)
• Participants with a history of hypersensitivity reactions to previous acupuncture treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Press Needle Group

Experimental group

Description:

Press Needle

Treatment:

Device: Press Needle

Sham Press Needle Group

Sham Comparator group

Description:

Sham Press Needle

Treatment:

Device: Sham Press Needle