Prokinetic Effect of Selected Nutraceuticals on Management of Gastrointestinal Disturbances Among Pulmonary Tuberculosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- --GIT disturbances
研究概览
简要总结
Anti-Tuberculosis Treatment (ATT) is one of the effective treatments of tuberculosis but the use of drugs for a long time put an adverse effect on the gut and other organs of the body. Nutraceuticals are the cheapest natural sources with therapeutic effects. These natural medicines help in alleviating gastrointestinal disturbances. This study will be conducted to overcome gastrointestinal issues with the help of nutraceuticals, which are more acceptable by the majority and have no side effects.
详细描述
The aim of this study will be to evaluate if Zingiber officinale, Carum carvi, L, and Mentha spicata L nutraceuticals can help in alleviating gastrointestinal disturbances in subjects which are more acceptable by the majority and have no side effects.
This Randomized Control interventional three arms Trial will comprise three phases. Patients will be randomized to Zingiber officinale, Carum carvi, L, and Mentha spicata L nutraceuticals or placebo for three months. We will evaluate symptoms assessment, dietary assessment, biochemical and physical analysis i.e. Acid-Fast Bacillus (AFB) for sputum, Chest X-ray (CXR), and Complete Blood Count (CBC) at baseline and after 3 months since the study started.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed Pulmonary TB patients (both genders)
- •Age group 18-65 years
- •Symptoms criteria (Rome IV)
排除标准
- •Patients ˃ 18 years and ˂ 65 years.
- •Patients registered with extra pulmonary disease
结局指标
主要结局
--GIT disturbances
时间窗: "1 Month" at study commencement (Phase 1)
GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 1.
GIT disturbances
时间窗: Termination of phase 3 (Washout period) "1 Month"
GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 3 which is wash out time.
次要结局
- A self-designed / pretested questionnaire("through study completion, an average of 9 months")
- Complete blood count (CBC)("1 Day" at study commencement (Phase 1))
- Acid-Fast Bacillus (sputum)("through study completion, an average of 9 months")
- Body Mass Index("through study completion, an average of 9 months")
- Chest X-ray (CXR)("1 Day" at study commencement (Phase 1))
研究者
Asma Latif
Dietician
Allama Iqbal Open University Islamabad