Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07271225

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUP Persahabatan

Jakarta, Jakarta Timur, 13230, Indonesia

Location status: Recruiting

Location contact

KEPK RSUPP

CONTACT

0214891708

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Press Needle

Device

Press needle is performed once at bilateral MA-TF1 Shenmen, MA-AH-7 Sympathetic, and MA-IC6 Stomach using Press Needle (Pyonex® 0,17x0,9 mm). Standard aseptic procedures are followed. Participants continue their routine pharmacological anti-emetics treatment.

Sham Press Needle

Device

Press needle is performed once at bilateral MA-TF1 Shenmen, MA-AH-7 Sympathetic, and MA-IC6 Stomach using Sham Press Needle. Standard aseptic procedures are followed. Participants continue their routine pharmacological anti-emetics treatment.

Primary outcomes

  1. Rhodes indeks of nausea, vomiting, and retching (RINVR)

    Time frame: Baseline, 1 day, 3 days, 7 days, 10 days, 14 days after intervention

    a validated patient-reported questionnaire used to measure the severity and impact of nausea, vomiting, and retching. It consists of eight items that evaluate the frequency, duration, and distress associated with these symptoms over a specific time period. Each item is scored using a Likert scale, and the total score reflects the overall symptom burden.

Secondary outcomes

  1. Adverse Events Related to Intervention

    Time frame: 1 day, 3 days, 7 days, 10 days, 14 days after intervention

    Any adverse events occurring after the intervention, including infection, pain, or skin irritation at the insertion site, will be monitored and recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

KEPK RSUPP

CONTACT

[email protected]

0214891708

Kevin Supratman, MD

CONTACT

[email protected]

08128080897

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Effectiveness and Safety of Auricular Acupuncture for Nausea and Vomiting Side Effects Induced by Anti-Tuberculosis Drugs in Pulmonary TB Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.