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临床试验/CTRI/2025/02/079999
CTRI/2025/02/079999尚未招募2 期

Effect of Sharbat Tamar hindi in Nausea and Vomiting during Pregnancy: A pre and post interventional study

National Institude Of Unani Medicine1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年2月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
Reduction in PUQE 24 score

研究概览

简要总结

Nausea and vomiting in pregnancy (NVP) is one of the most common problem during pregnancy with an incidence of 70-85%.1 It occur at any time of the day, in 80% of cases nausea and vomiting occur during the day and in 3% it happens in afternoon and evening. During pregnancy, women normally experience nausea and vomiting known as morning sickness.2 NVP begin in first trimester at about 6-8 weeks, peaking at about 9 weeks and subside at about 12 weeks of gestation, and it persist in some cases even after 20 weeks of gestation.3 NVP causes discomfort and disrupt the woman’s daily life in mild cases, while in severe cases, it endanger the health of both mother and fetus.2 The severe vomiting in pregnancy is known as hyperemesis gravidarum, which often requires hospitalization due to weight loss, poor nutrition, and dehyderation.4 NVP causes inadequate food intake resulting in malnutrition, reduced energy and fatigue, electrolyte imbalance, weakness and dehydration.2 It is accompanied by an increased risk of maternal stress, anxiety, depression, low quality of life and reduction in maternal physical and social function.5 In conventional medicine, the treatment is mainly symptomatic which includes dietary changes, nutritional therapy, oral pharmacological treatment and hospitalization (if severe) with intravenous fluid replacement. Vitamin B6 is used as the first-line of treatment for NVP; however, current studies support the use of metoclopramide and antihistamines such as doxylamine and ondansetron. In early pregnancy, these drugs are avoided due to their potential teratogenic effects. Hence, there is an increasing tendency towards the use of alternate medicine especially the herbal medicine to fulfil this demand.1 Various formulations are available in USM such as Sharbat-i-turanj, Sharbat-i-leemu, Sharbat-i-ghaura, Sharbat-i-zanjabeel, Jawarish-i-oodtursh, Murraba-i-amla etc,6,7 which can be used in the management of NVP, but scientific studies are lacking. 6.2 6.3 7. Therefore, it has been decided to conduct a clinical trial to evaluate the effect of Sharbat Tamar hindi 8 in pregnancy induced nausea and vomiting

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

  • Pregnant women in age group of 18-35 years with singleton fetus between 6-10 weeks of gestation having nausea and vomiting of mild to moderate (3-12) PUQE score.

排除标准

  • Patient with PUQE Score more than 3 History of peptic ulcer gastroenteritis pancreatitis cholecystitis appendicitis renal stone systemic diseases like HTN GDM thyroid dysfunction Multiple pregnancy abortion ectopic pregnancy molar pregnancy.

结局指标

主要结局

Reduction in PUQE 24 score

时间窗: At baseline, 2 weeks, 4 weeks

次要结局

未报告次要终点

研究者

发起方
National Institude Of Unani Medicine
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Vandana Bodana

National Institude of Unani Medicine

研究点 (1)

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