Safety and Efficacy of Ear Acupuncture for Antituberculosis Drug-Related Nausea and Vomiting
NCT ID: NCT07271225
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
58 participants
INTERVENTIONAL
2025-11-05
2026-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Press Needle Group
Press Needle
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.
Sham Press Needle Group
Sham Press Needle
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
17 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Kevin Supratman
MD
Locations
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RSUP Persahabatan
Jakarta, Jakarta Timur, Indonesia
Countries
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Central Contacts
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Facility Contacts
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KEPK RSUPP
Role: primary
Other Identifiers
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0215
Identifier Type: -
Identifier Source: org_study_id
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