A randomised double arm comparative open label multicentre clinical study to evaluate the safety and efficacy of Glutathione 50 mg plus Glutamate 500 mg plus Glutamine 500 mg plus L Arginine 3 gm vs L Arginine 3 gm plus Proanthocyanidin 75 mg in the management of Intrauterine Growth Restriction (IUGR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To compare the change in fetal biometric parameters (estimated fetal weight, abdominal circumference) between the two treatment arms.
研究概览
简要总结
IUGR is a major cause of perinatal morbidity and mortality, often linked to poor uteroplacental perfusion and oxidative stress. This study compares two regimens: the investigational formulation (Glutathione, Glutamate, Glutamine, L-Arginine) designed to antioxidant and metabolic support, versus a standard L-Arginine + Proanthocyanidin regimen. The trial will assess whether adding glutathione and amino acids offers superior short-term improvements in fetal biometry parameters in pregnancies with IUGR.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female of childbearing age 18–45 years (inclusive) Singleton viable pregnancy with gestational age 32–37 weeks Ultrasound-confirmed IUGR, defined as Estimated Fetal Weight (EFW),10th percentile for gestational age Hemodynamically stable and not requiring inpatient care at screening Willing and able to provide written informed consent Willing to comply with study procedures, visit schedule, and follow-up.
排除标准
- •Multifetal gestation (twins or higher) Major fetal structural anomaly or known chromosomal abnormality Severe pre-eclampsia/eclampsia or uncontrolled hypertension (systolic greater than or equal to 160 mmHg or diastolic greater than or equal to 110 mmHg) Severe maternal systemic disease is likely to affect fetal growth or outcome (e.g., uncontrolled Type 1 diabetes, severe cardiac disease, active systemic lupus with nephritis).
- •Placental conditions likely responsible for growth restriction are not amenable to medical therapy (e.g., placenta previa with major bleeding, confirmed placental abruption).
- •Known rhesus isoimmunization with significant fetal anaemia or hydrops.
- •Evidence of active intrauterine infection (e.g., CMV, Toxoplasma) suspected to cause IUGR.
- •Any condition placing the mother or fetus at unacceptable risk as judged by the investigator.
结局指标
主要结局
To compare the change in fetal biometric parameters (estimated fetal weight, abdominal circumference) between the two treatment arms.
时间窗: V1 Screening/ Baseline (Day 0), | V2 Randomisation (Day 1), | V3 1st Follow-up (Day 7 ± 1), | V4 Last Follow-up (Day 15 ± 1)
次要结局
- To compare birth weight and gestational age at delivery(To assess maternal safety and tolerability)
研究者
DrMadhusmita Nayak
Aurashree Multispeciality Clinic