An exploratory single arm open label clinical study to evaluate the effect of Bilwa Lajadi cookie for nausea and vomiting in pregnancy
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Nausea and Vomiting assessed by Pregnancy Unique Quantification of Emesis score
研究概览
简要总结
Nausea and vomiting of pregnancy NVP is one of the most common medical conditions affecting approximately 50 to 80 percentage of pregnant women during the first trimester is also known vyakta garbha lakshana in AyurvedaThough typically considered a physiological adaptation NVP can significantly impact a womans physical health emotional well being nutritional intake and overall quality of life In more severe cases it may lead to complications such as dehydration weight loss and hospitalizationWhile modern antiemetics are available concerns regarding fetal safety and maternal side effects prompt many pregnant women to seek natural dietary or Ayurvedic alternativesTraditional Ayurvedic texts recommend Bilwa Aegle marmelos Laja puffed rice and other herbs for balancing digestive fire and managing emesis in pregnancyThis study proposes the development and clinical evaluation of an Ayurveda based functional food Bilwa Lajadi Cookie as a novel palatable and safe dietary intervention for NVP The cookie is intended to provide symptomatic relief while ensuring nutritional support during early pregnancy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Primi and multi gravida up to G2 P1between 18 to 35 years of age with symptoms of nausea and vomiting in first trimester 2 Patient having confirmed diagnosis of pregnancy 3 Patient having ANC profile CBC Blood Group Urine Routine RBS Early pregnancy USG scan Viability scan.
排除标准
- •1 Multigravida with more than second parity and with bad obstetric history 2 Pregnant women with symptoms of hyperemesis gravidarum dehydration twin pregnancy and molar pregnancy 3 Diagnosed cases of diabetes mellitus hypertension anaemia and hypothyroidism during pregnancy 4 History of peptic ulcer appendicitis hepatitis pancreatitis presenting with vomiting.
结局指标
主要结局
Nausea and Vomiting assessed by Pregnancy Unique Quantification of Emesis score
时间窗: Baseline 15th day 30th day and 45 th day
次要结局
- Quality of Life Assessment by Nausea Vomiting in pregnancy questionnaire NVPQOL(Baseline 15th day 30th day and 45 th day)
研究者
Dr Shivani Dhepe
KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate studies And Research Centre