Ear acupuncture to reduce nausea and vomiting from tuberculosis medicines
Effectiveness and Safety of Auricular Acupuncture for Nausea and Vomiting Side Effects Induced by Anti-Tuberculosis Drugs in Pulmonary TB Patients
This trial will test whether press-needle ear acupuncture can reduce nausea and vomiting in people taking medicines for pulmonary tuberculosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 17 Years and up |
| Sex | All |
| Sponsor | Indonesia University Academic / other |
| Locations | 1 site (Jakarta, Jakarta Timur) |
| Trial ID | NCT07271225 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Jakarta, Jakarta Timur
- RSUP Persahabatan — Jakarta, Jakarta Timur, Indonesia (Recruiting)
Study contacts
- Study coordinator: Kevin Supratman, MD
- Email: kevin.supratman@ui.ac.id
- Phone: 08128080897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.