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临床试验/CTRI/2016/02/006628
CTRI/2016/02/006628招募中2 期

A controlled clinical study for evaluation of the effect of rasayana drugs and micronized progesterone during first trimester of pregnancy

IPGT AND RA GAU JAMNAGAR1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年12月30日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Relief in complaints of first trimester of pregnancy

研究概览

简要总结

The first trimester of pregnancy lasts from conception until 12 weeks gestation. Women experience a wide range of symptoms as their bodies undergo some amazing

changes during the first trimester. Some symptoms during this stage include

Nausea and vomiting

Fatigue

Food aversion

Breast growth and tenderness

Tiredness

Constipation

Regurgitation and heartburn

Lower abdominal pain

 Frequency micturation etc.

In Group A rasayana granules 10gm BD for 2 months will be given.

In Group B micronized progesteron 200mg BD will be given for 2 months.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Elderly primigravida 2.Pregnancy after infertility
  • History of threatened abortion.
  • 4.History of habitual abortion.
  • Delayed fetal pole development
  • Choriodecidual hemorrhage
  • History of Blightened ovum, IUFD, Congenital deformity, previous preterm birth,
  • Successful pregnancy after IVF and ET.

排除标准

  • Pregnancy with uterine malformation and congenital defect of uterus.
  • Pregnancy with uterine fibroid and carcinoma.
  • Pregnancy with sexually transmitted disease
  • Severe PIH.

结局指标

主要结局

Relief in complaints of first trimester of pregnancy

时间窗: 60 days

次要结局

  • continuation of pregnancy and fetal well being.(60 days)

研究者

发起方
IPGT AND RA GAU JAMNAGAR
申办方类型
Research institution and hospital

研究点 (1)

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