跳至主要内容
临床试验/CTRI/2025/12/099162
CTRI/2025/12/099162尚未招募2/3 期

STUDY THE EFFICACY OF EVOKE GEL (ADHATODA VASICA) LOCAL APPLICATION NABHI BASTI BHAGA TO INITIATE UTERINE CONTRACTIONS BEYOND 41 WEEKS OF GESTATION WITH SPECIAL REFERANCE TO LABOUR INDUCTION:OPEN RANDOMIZED CONTROL CLINICAL STUDY

Dr Meghana Anand Nikum1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年12月26日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
To determine the efficacy of "Evoke Gel(ADHATHODA VASACA)" in initiating uterine contractions beyond 41 weeks of gestation in cases of labor induction.

研究概览

简要总结

Induction of labor is the initiation of uterine contractions before the spontaneous onset of labor with or without ruptured of membranes. By medical or surgical means for the purpose of delivery. It may be categorized as elective or indicated. In general, induction of labor may be indicated when the benefit of delivery to the mother and fetus outweighs the potential problem if the pregnancy continues. There may be maternal or fetal indications. These conditions may arise if the maternal medical or surgical condition worsens under expectant therapy or if there is evidence of impaired intrauterine existence. If obstetric data confirm that the pregnancy is at term or if fetal pulmonary maturity has been documented, the decision to induce labor is not difficult.  When the cervix is closed and uneffaced, labor induction is often preceded by cervical ripening, a process to soften and open the cervix. This is somewhat of a misnomer in that cervical ripening, per se, may also be a means of labor induction. Prolonged pregnancy or postulates has been defined in the literature on the basis of weeks completed frogs the first day of the last menstrual period (LMP) Definitions have ranged from 41 to 43 completed weeks. The most often used definition is 42 completed weeks. The incidence of prolonged pregnancy has been reported to range from 3.5 to 14 percent of all pregnancies.

Adhatoda vasica  is a good source  of pyrroloquinazoline  alkaloids  such  as  vasicine,  vasicol,  adhatonine,  vasicinone,  vasicinol, vasicinolone  etc.  Uterine stimulant activity and moderate hypotensive activity of the alkaloidshave been observed. Vasicine is metabolized to vasicinone. leaf  extract  showed  that  it  contained  0.85 percent  vasicine  and  0.027 percent vasicinone. Adhatoda  vasica  possesses  abortifacient  and  uterotonic  properties  due to  the  presence of  vasicine  in its extracts. The compound initiated rhythmic contractions of human myometrial strips from both non-pregnant and pregnant uterus. It indicating that the action of vasicine was probably enhanced by the synthesis and release of prostagladins.

研究设计

研究类型
Interventional
分配方式
Other
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

  • 1.In married women with age group of 21-35 years.
  • 2.Post-term, post-maturity, post-dated pregnancy.
  • 3.Singleton live pregnancy with normal AFI.
  • 4.Cephalic presentation of fetus irrespective of gravida status.
  • 5.Gestational age greater than 41 weeks.

排除标准

  • 1.Gestational age less than 37 weeks 2.Contracted pelvis and cephalopelvic disproportion 3.Abnormal presentation 4.Active genital herpes infection 5.Previous uterine surgery like L.S.C.S, Fibroid 6.Gravida with systemic or other medical disorders.(DM,HTN) 7.High risk pregnancy including jaundice, preeclampsia, anemia, PIH 8.Precious pregnancy
  • Patients are excluded with no previous reports of CBC,USG.

结局指标

主要结局

To determine the efficacy of "Evoke Gel(ADHATHODA VASACA)" in initiating uterine contractions beyond 41 weeks of gestation in cases of labor induction.

时间窗: Ninety minutes

次要结局

  • To assess the role of Dinoprostone gel vaginal application for induction of labor beyond 41 weeks of gestation(Twelve to Twenty four hours)

研究者

发起方
Dr Meghana Anand Nikum
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Meghana Anand Nikum

Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangali Maharashtra India

研究点 (1)

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