Ear acupuncture to reduce nausea and vomiting from tuberculosis medicines
Official title: Effectiveness and Safety of Auricular Acupuncture for Nausea and Vomiting Side Effects Induced by Anti-Tuberculosis Drugs in Pulmonary TB Patients
Run by Universitas Indonesia · NCT07271225 · Data updated 2026-11-12
This trial will test whether press-needle ear acupuncture can reduce nausea and vomiting in people taking medicines for pulmonary tuberculosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 17 Years and up |
| Sex | All |
| Enrollment | 58 (estimated) |
| Sponsor | Universitas Indonesia Academic / other |
| Locations | 1 site (Jakarta, Jakarta Timur) |
| Status | Recruiting |
| Started | November 5, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | December 9, 2025 |
| Trial ID | NCT07271225 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 17 or older with pulmonary tuberculosis who develop nausea and vomiting after starting antituberculosis drugs and who meet the study's medical and skin-site eligibility criteria are ideal candidates.
✕Probably not a fit
People whose nausea/vomiting began before TB treatment or is due to other medical conditions, those on long-term individualized DR-TB regimens, with uncontrolled diabetes, unstable hemodynamics, or skin lesions at ear sites are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with pulmonary tuberculosis who develop nausea and vomiting after starting antituberculosis medications will be randomly assigned to receive either press-needle ear acupuncture or a visually identical sham press-needle. Nausea and vomiting scores will be recorded before, during, and after the intervention to compare symptom change between groups, and safety will be monitored. The trial includes people on drug-sensitive regimens and those on short-course BPaL/BPaLM regimens for resistant disease, and excludes participants with conditions that could confound nausea or prevent safe use of press needles. The intervention is delivered at a single hospital site in Jakarta, Indonesia.
Why it matters
Potential benefit: If effective, this could reduce nausea and vomiting so more people complete TB treatment and lower the risk of treatment failure or drug resistance.
How similar studies have gone: Acupuncture and auricular stimulation have shown benefit for other causes of nausea such as chemotherapy and postoperative nausea, but using press-needle ear acupuncture specifically for TB drug–related nausea is relatively novel and not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
RSUP Persahabatan
Jakarta, Jakarta Timur, Indonesia Recruiting
Study contacts
- Study coordinator: Kevin Supratman, MD
- Email: kevin.supratman@ui.ac.id
- Phone: 08128080897
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.