Effectiveness of Individualized homeopathy as an add on to standard treatment of Pulmonary tuberculosis- a randomized parallel arm double blind, placebo-controlled study (HAPT Trial)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Clinical recovery of patient, termed as cure as per WHO criteria (Cure).
研究概览
简要总结
Tuberculosis is one of the top ten leading causes of death worldwide owing to 1.5 million TB related deaths in 2018. About 44% of global TB cases in 2018 were reported from South-East Asia and India reported 27% cases, the highest in SEAR region.1 India has second highest burden of MDR-TB in the world with an estimated 99,000 new cases per year. TB continues to have a significant impact on healthcare in India. This study is undertaken utilizing homoeopathic medicine as an adjuvant to the standard treatment in TB Patients with ADRs were more susceptible to develop unfavorable results of anti-TB treatment which emphasizes on the importance of developing strategies to control ADRs both to improve the quality of life and to treat TB safely. The study focuses on Integrative homoeopathic treatment in improving the treatment outcome, decrease ADR and improve the quality of life leading to improved medication compliance. This shall be a randomized, parallel arm, double blind, placebo, controlled trial of 3 years duration. The primary objective of the study isto compare the effectiveness of individualized homoeopathic treatment as an add-on to the standard treatment in curing Pulmonary Tuberculosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Pulmonary tuberculosis patients with positive sputum culture.
- •Patients with controlled Diabetes mellites and hypertension with medication.
- •Patients who are willing to give written informed consent.
排除标准
- •Participation in another clinical trial.
- •Female patients in lactation period, pregnancy or planning to get pregnant during the trial.
- •Known patients with severe primary diseases such as cancer, cardiovascular system, digestive system, kidney, and hematopoietic system diseases.
- •Patients co-infected with HIV.
- •Patients with mental illness.
- •Subjects considered to be unable to complete the study, or not suitable for the study by researchers.
结局指标
主要结局
Clinical recovery of patient, termed as cure as per WHO criteria (Cure).
时间窗: At 2nd, 3rd, 4th, 5th, 6th, 12th & 18th month
次要结局
- Time to resolution of all pulmonary tuberculosis symptoms.
- Change in severity of symptoms/resolution as per clinical syndromes associated with Pulmonary tuberculosis at every month.(every month)
- Time to sputum conversion.(At 2nd, 3rd, 4th, 5th, 6th, 12th & 18th month)
- Resolution of chest X-ray changes of lungs(At 2nd, 6th, & 12th month)
- Change in Erythrocyte Sedimentation Rate(At 2nd, 6th, & 12th month.)
- Change in C-reactive protein.(At 2nd, 6th, & 12th month)
- Relapse in patients after 1 year of completion of treatment(at 12 month)
- Adverse events throughout the study.(every month)
- Compare Quality of Life (WHOQOL-Bref) in patients.(at 2nd, 6th, 12th & 18th month)
研究者
Dr Debadatta Nayak
Central Council for Research in Homoeopathy