Tuberculosis, Pulmonary
Conditions
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
Interventions
DEVICEPress 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.
DEVICESham 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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
Intervention model description
The intervention group will receive press needle, while the control group will receive sham press needle
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rhodes indeks of nausea, vomiting, and retching (RINVR) | Baseline, 1 day, 3 days, 7 days, 10 days, 14 days after intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Related to Intervention | 1 day, 3 days, 7 days, 10 days, 14 days after intervention | Any adverse events occurring after the intervention, including infection, pain, or skin irritation at the insertion site, will be monitored and recorded. |
Countries
Indonesia
Contacts
Primary ContactKevin Supratman, MD
Backup ContactKEPK RSUPP
Outcome results
None listed