An Open Label Randomized Controlled Clinical Study To Evaluate The Effect Of Matulungadi Vati In Management Of Garbhini Chardi Vis-a-vis Emesis Gravidarum
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study presents an open label randomized controlled clinical study to evaluate the efficacy and safety of Matulungadi vati in the management of Garbhini Chardi, which corresponds to nausea and vomiting of pregnancy. The study aims to compare the Ayurvedic formulation with Doxylamine Pyridoxine tablet in pregnant women during the first trimester.
Garbhini Chardi is described in classical Ayurvedic texts as a complication of pregnancy caused mainly by aggravated Vata and Pitta and physiological changes due to the growing fetus. Modern medicine attributes nausea and vomiting of pregnancy to hormonal changes such as increased beta hCG and estrogen. Although conventional drugs are effective, they may cause side effects and reduce patient compliance, creating the need for safer alternatives.
Matulungadi vati is prepared from Matulunga, Dadima, Laaja, Daruharidra and Sharkara, which possess antiemetic, digestive and soothing properties according to Ayurveda. Previous studies have evaluated similar individual drugs, but there is limited evidence on this specific combination in vati form.
The study will include 60 pregnant women divided into two groups of 30 each. One group will receive Doxylamine Pyridoxine and the other will receive Matulungadi vati for seven days. Assessment will be based on nausea intensity, vomiting frequency, appetite, wellbeing, taste perception, sleep disturbance and patient satisfaction. Appropriate statistical tests will be applied to analyze the results.
The study aims to provide scientific evidence for an effective, safe and patient friendly Ayurvedic intervention for the management of nausea and vomiting during early pregnancy.
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
- 21.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women aged 21 to 35 years First trimester of pregnancy less than or equal to 12 weeks gestation Symptoms of nausea and or vomiting not exceeding more than 5 episodes per day Willing to participate in the study.
排除标准
- •Known Case Of Hyperemesis gravidarum Known Case Of Systemic illness or endocrine disorders Known Case Of Severe anemia less than 6g per dl Hepatic or Renal dysfunction Known Case Of High Risk Pregnancy Diagnosed Multiple gestation Use of any antiemetic drugs in past 48 hours.
研究者
Dr Chinmayee P
JSS Ayurveda Medical College and Hospital