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

NCT ID: NCT07271225

Last Updated: 2025-12-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2026-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Tuberculosis, Pulmonary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention group will receive press needle, while the control group will receive sham press needle
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.

Study Groups

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Press Needle Group

Press Needle

Group Type EXPERIMENTAL

Press Needle

Intervention Type 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 Group

Sham Press Needle

Group Type SHAM_COMPARATOR

Sham Press Needle

Intervention Type 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.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Kevin Supratman

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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RSUP Persahabatan

Jakarta, Jakarta Timur, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Kevin Supratman, MD

Role: CONTACT

08128080897

KEPK RSUPP

Role: CONTACT

0214891708

Facility Contacts

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KEPK RSUPP

Role: primary

0214891708

Other Identifiers

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0215

Identifier Type: -

Identifier Source: org_study_id

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