CTRI/2025/06/089191尚未招募Phase 3 4
Efficacy Safety and Tolerability of Ayurveda regimen as an adjunct to antituberculosis treatment ATT and macronutrient supplementation on body weight nutritional outcomes and quality of life in adults with newly diagnosed drug sensitive smear positive Pulmonary Tuberculosis An open label randomized controlled parallel arm clinical study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 1,250
- 试验地点
- 8
- 主要终点
- •Change in body mass index (BMI) from baseline to day 180
研究概览
简要总结
The current treatment for drug-susceptible TB (DS-TB) involves a combination of four antibiotics: isoniazid (INH), rifampicin (RIF), pyrazinamide (PZA), and ethambutol (EMB), which target Mycobacterium tuberculosis via different mechanisms. Despite effectiveness, adverse effects like liver dysfunction and drug resistance are concerns. Limited new drug approvals since 2013 highlight the need for more efficient anti-TB drugs.Additionally, the emergence of drug-resistant strains poses a substantial risk to successful treatment outcomes. Given these challenges, there is a critical need for novel adjunct therapeutic strategies to address drug resistance, minimize toxicity, and enhance patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Willing and able to give informed consent for participation in the trial.
- •2.Individuals of any gender aged 18 years or above.
- •3.Newly diagnosed cases of Pulmonary Tuberculosis (M.
- •Tb positive on molecular test e.g. GeneXpert or TRUENAT or sputum smear positive pulmonary TB on direct microscopy for acid fast bacilli (at least 1+ on the IUATLD/WHO scale) 4.Sensitive to rifampicin by sputum based drug sensitivity test (may be sensitive or resistant to isoniazid) 5.Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter.
- •6.Liver function tests within reference range (as per the reference value of the laboratory assigned for the study investigations).
排除标准
- •1.Patients with prehistory of TB, EP, relapse, and other forms of TB 2.Participants with pre-existing HIV, liver, Kidney and cardiac diseases 3.Hb<7 gm/dl and HbA1C > 10% 4.Pregnancy and lactation, Hypersensitivity to ATT.
结局指标
主要结局
•Change in body mass index (BMI) from baseline to day 180
时间窗: Time points- Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180
次要结局
- •Change in body weight from baseline to day 180(Time points- Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180)
- • Change in body composition from baseline to day 180, assessed through Dual Energy X-ray Absorptiometry (DEXA)(Time points- Baseline, Day 180)
- • Change in health-related quality-of-life (HRQoL) in pulmonary tuberculosis from baseline to day 180, assessed through SF-12 questionnaire(Time points- Baseline, Day 90, Day 180)
- •Time to attain sputum smear negative for AFB(Time points- Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180)
- •Proportion of participants who attain sputum smear negative for AFB at each follow-up time points ((Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180) and culture conversion to negative status through MGIT (Mycobacteria Growth Indicator Tube)(Time points - Baseline, Day 180))
- • Quantitative assessment of mycobacterial load through quantitative polymerase chain reaction (qPCR for Mycobacterium tuberculosis)(Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180)
- •Incidence of treatment emergent adverse events(Baseline to Day 180)
- •Change in laboratory parameters of safety (CBC, LFT, KFT)(Baseline, Day 30, Day 90, Day 180)
- • To assess the tolerability of Ayurvedic therapeutic regimen as adjunct to ATT and macronutrient supplementation in Pulmonary tuberculosis (through assessment of treatment adherence, proportion of participants dropped out or withdrawn from the study due to AE/ADR and participant self reported tolerability)(Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180)
研究者
Dr Sonali Sarkar
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry
研究点 (8)
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