Safety and Efficacy of Ear Acupuncture for Antituberculosis Drug-Related Nausea and Vomiting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Press Needle, Sham Press Needle.
- Who it may be relevant to
- Registry conditions: Tuberculosis, Pulmonary. Basic parameters: from 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness and Safety of Auricular Acupuncture for Nausea and Vomiting Side Effects Induced by Anti-Tuberculosis Drugs in Pulmonary TB Patients
Overview
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
Interventions
- Device Press Needle
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. - Device Sham Press Needle
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 outcome measures
- Rhodes indeks of nausea, vomiting, and retching (RINVR) [Time frame: Baseline, 1 day, 3 days, 7 days, 10 days, 14 days after intervention]
Secondary outcome measures (1)
- Adverse Events Related to Intervention [Time frame: 1 day, 3 days, 7 days, 10 days, 14 days after intervention]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Indonesia · 1 center
- RSUP Persahabatan — Jakarta
Identifiers
NCT: NCT07271225 · 0215