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

NCT07271225 | Recruiting

• 1 other identifier: 0215
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 day, 3 days, 7 days, 10 days, 14 days after intervention

Secondary Outcomes (1)

• Adverse Events Related to Intervention

  1 day, 3 days, 7 days, 10 days, 14 days after intervention

Study Arms (2)

Press Needle Group

EXPERIMENTAL

Press Needle

Device: Press Needle

Sham Press Needle Group

SHAM COMPARATOR

Sham Press Needle

Device: Sham Press Needle

Interventions

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.

Press Needle Group

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.

Sham Press Needle Group

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSUP Persahabatan

Jakarta, Jakarta Timur, 13230, Indonesia

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kevin Supratman, MD

CONTACT

08128080897; kevin.supratman@ui.ac.id

KEPK RSUPP

CONTACT

0214891708; ethics@rsuppersahabatan.co.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: The intervention group will receive press needle, while the control group will receive sham press needle

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: November 5, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)