An Open-Labelled Three-Armed Randomized Controlled Clinical Trial To Evaluate The Effect Of Sub-Lingual Brahmi (Bacopa Monnieri) Drops In The Management Of Abdominal Colic

Dr Kajal Patel1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2025年4月15日最近更新: 2025年3月25日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1
主要终点: Decrease in Pain, Decrease in VAS Pain Score, Decrease in intensity and duration of pain, Decrease in following criteria of coliky pain

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of this study is to evaluate and compare the efficacy of Brahmi extract in two forms sublingual drops and capsulesagainst a conventional pharmaceutical treatment comprising Mefenamic Acid and Dicyclomine Hydrochloride for the management of abdominal colic. The secondary objective is to preparation of brahmi drops and brahmi capsule. Analytical study of drops and capsule.The trial follows an open-labelled, three-armed, randomized controlled design with a sample size of 60 patients, divided into three groups of 20 each. The study spans 10 days, including a 3-day treatment period and a 7-day follow-up. Participants will be assessed based on subjective criteria such as pain intensity, duration, and location, as well as objective criteria like tenderness, nausea, vomiting, diarrhea, fatigue, and fainting, using standardized assessment scales.

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 60.00 Year(s)（—）
性别: All

入选标准

•Participants aged between 18 and 60 years.
•Patients presenting with abdominal colicky pain that does not require immediate surgical intervention.
•Patients diagnosed with the following conditions, where Brahmi (Bacopa monnieri) drops may be beneficial: i.
•Multiple urinary calculi (unilateral or bilateral) without accompanying hydronephrosis.
•Cholecystitis and cholelithiasis without severe complications.
•Abdominal cramps and biliary colic.
•Dysmenorrhea (painful menstruation).
•Appendicitis not necessitating immediate surgical intervention.
•Patients of all genders, regardless of caste, religion, and socio-economic status.

排除标准

•Patients with renal or ureteric calculi that are accompanied by severe hydronephrosis, which requires immediate or urgent intervention.
•Individuals with obstructive renal calculi leading to severe infections, such as pyelonephritis, that necessitate immediate medical treatment.
•Patients diagnosed with obstructive jaundice, a condition requiring urgent management due to bile duct obstruction, often caused by gallstones or tumors.
•Any patient with a condition requiring immediate surgical intervention, such as:
•Complete bowel obstruction.
•Perforated appendix.
•Any other acute abdominal condition that mandates urgent surgery.
•Patients with severe systemic conditions, such as uncontrolled diabetes or cardiovascular disease, that may complicate the management of abdominal colic or interfere with the study outcomes.
•Pregnant or breastfeeding women, due to potential risks and lack of sufficient safety data on the use of Brahmi (Bacopa monnieri) drops in these populations.
•Patients Who are not willing to give consent.

结局指标

主要结局

Decrease in Pain, Decrease in VAS Pain Score, Decrease in intensity and duration of pain, Decrease in following criteria of coliky pain