Effectiveness and Safety of Auricular Acupuncture for Nausea and Vomiting Side Effects Induced by Anti-Tuberculosis Drugs in Pulmonary TB Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Rhodes indeks of nausea, vomiting, and retching (RINVR)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Rhodes indeks of nausea, vomiting, and retching (RINVR)
时间窗: 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.
次要结局
- Adverse Events Related to Intervention(1 day, 3 days, 7 days, 10 days, 14 days after intervention)
研究者
Kevin Supratman
MD
Indonesia University