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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17+
SponsorIndonesia University

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Press Needle
  • Sham Press Needle

Treatment groups

58 Participants
are divided into 2 treatment groups

Sponsors and collaborators