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临床试验/CTRI/2022/07/044131
CTRI/2022/07/044131尚未招募不适用

A Clinical study to evaluate the Efficacy of Kadambmasha Anuvasana Basti and Badrodak Asthapna Basti in Sukh and Nirupdrava Prasava

Principal RGGPG Ayurvedic College and Hospital Paprola1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年8月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1. Onset of spontaneous labour and normal progress of labour.

研究概览

简要总结

Research Report will be soon published after the completion of trial. 100 patients fulfilling the inclusion and exclusion criteria will be randomly selected from the OPD and IPD of Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospital, Paprola. Patients will be divided randomly into 2 groups; Group I and Group II each with 50 patients. Group I will be given Kadambmasa Anuvasana Basti (Matra Basti) twice weekly for consecutive 3 weeks and Badrodak Asthapna Basti followed by Anuvasna Basti at the onset of labour while Group II includes the pregnant women under observation by following standard protocol used for ANC and normal labour (non-interventional). Result will be assessed on the basis of subjective and objective assessment criteria.

研究设计

研究类型
Interventional
分配方式
Adaptive randomization, such as minimization
盲法
Not Applicable

入排标准

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

入选标准

  • Cases having haematological/routine ANC investigations within normal limits.
  • Patients having adequate pelvis, borderline pelvis and cephalic presentation.

排除标准

  • Cephalopelvic disproportion.
  • Patient not willing for trial.
  • Patients having mal presentation.
  • Antepartum haemorrhage.
  • Patients having any gynaecological conditions or systemic disease.

结局指标

主要结局

1. Onset of spontaneous labour and normal progress of labour.

时间窗: 32 weeks to onset of Labour (5-7 weeks). | 1. Patient will be observed after intervention whether the pregnant woman has sukha and nirupdrava prasava or not and | 2. whether onset of labour is spontaneous or induced

2. Delivery of fetus with minimal aids.

时间窗: 32 weeks to onset of Labour (5-7 weeks). | 1. Patient will be observed after intervention whether the pregnant woman has sukha and nirupdrava prasava or not and | 2. whether onset of labour is spontaneous or induced

次要结局

  • Uneventful complition of labour without interfering maternal and fetal health(Mother and Infant will be observed regularly for 14 days after delivery for any complication)

研究者

发起方
Principal RGGPG Ayurvedic College and Hospital Paprola
申办方类型
Government medical college

研究点 (1)

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