跳至主要内容
临床试验/CTRI/2024/03/064729
CTRI/2024/03/064729尚未招募2/3 期

An Exploratory Study To Evaluate The Effect of Siddharthakadi Basti in Retained Products of Conception

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Expulsion of retained products of conception

研究概览

简要总结

INTRODUCTION

Retained products of conception (RPOC) are a common and treatable complication after delivery or termination of pregnancy. The presence of chorionic villi, indicating the existence of trophoblastic tissue or remnants of the placenta, serves as the key criterion for pathologically diagnosing Retained Products of Conception (RPOC).

This single-arm, open-labeled exploratory study aims to fill this gap by examining the impact of Siddharthakadi basti on RPOC. By delving into the synergistic potential of traditional practices like basti, the study seeks to provide valuable insights into the ayurvedic management of RPOC, potentially offering safer and more effective options for women’s reproductive health.

AIMS AND OBJECTIVES

• To understand the etiopathogenesis of Retained products of conception.

• To find out the efficacy of Siddharthakadi basti in the effect of Retained products of conception.

• PRIMARY OBJECTIVE: Expulsion of retained products of conception.

• SECONDARY OBJECTIVE: 1. Stops p/v bleeding 2. Relief in abdominal pain

METHODOLOGY MATERIALS AND METHODS

❖ Step-1: Conceptual study - The detailed study of Retained products of conception will be carried out.

❖ Step-2: A detailed review of the drug will be done.

❖ Step-3: Therapeutic intervention.

Study Type-Exploratory Study

Study Design- A single-arm open-labeled exploratory study

Study Setting- The OPD and IPD of AIIA

Sample Size 30

Description- siddharthakadi Kwatha 480ml and  siddharthakadi Tail 120ml

Duration of treatment-For maximum 8 days

FOLLOW-UP: -Patient will be monitored daily during basti and will be advised for repeat ultrasonography (USG) after treatment.

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
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Married Female Patient of age 18-45 years old.
  • Thick irregular endometrium on trans-vaginal sonography suggesting RPOC.
  • (ICD NO.-O03.4).

排除标准

  • Patients with untreated urogenital infections.
  • Patients suffering from any chronic debilitating disease like diabetes mellitus hypertension, sexually transmitted disease, hepatitis B.
  • Patients not willing to be included in the study.

结局指标

主要结局

Expulsion of retained products of conception

时间窗: Maximum 8 days of drug intervention | FOLLOW-UP | Patient will be monitored daily during basti and will be advised for repeat ultrasonography | (USG) after treatment.

次要结局

  • 1. Stops P/V Bleeding(2. Relief in abdominal pain)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr AVANIKA GUNJIYAL

All India Institute of Ayurveda

研究点 (1)

Loading locations...

相似试验