An interventional study of Press Needle and Sham Press Needle in Tuberculosis, Pulmonary, sponsored by Indonesia University. Recruiting at 1 site in Indonesia. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
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
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's planned enrollment of 58 is below the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Press Needle
Device: Press Needle
Sham Press Needle
Device: Sham 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.
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.
Rhodes indeks of nausea, vomiting, and retching (RINVR)
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.
Time frame: Baseline, 1 day, 3 days, 7 days, 10 days, 14 days after intervention
Adverse Events Related to Intervention
Any adverse events occurring after the intervention, including infection, pain, or skin irritation at the insertion site, will be monitored and recorded.
Time frame: 1 day, 3 days, 7 days, 10 days, 14 days after intervention
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Jun 2026, 6 months after the start.
Of 42 non-industry interventional studies with no phase under Tuberculosis, Pulmonary, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's planned 6 months is below that.
Counting every sponsor, half of 42 studies reached it within 17 months; a quarter within 11 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
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