临床试验/CTRI/2025/12/099438

CTRI/2025/12/099438尚未招募2/3 期

A randomized clinical trial to evaluate the effect of Ayush RP as an adjuvant in prevention of acute pain crises in sickle cell Disease in students of selected Ekalavya Model Residential Schools

Central Council for Research in Ayurvedic Sciences11 个研究点分布在 1 个国家目标入组 100 人开始时间: 2025年12月30日最近更新: 2025年10月30日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方: Central Council for Research in Ayurvedic Sciences
入组人数: 100
试验地点: 11
主要终点: Frequency of sickle cell-related pain crises during the study period

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

1. The clinical course of patients with sickle cell disease (SCD) is highly variable due to the interplay of many genetic and environmental factors. Although hydroxyurea (HU) reduces morbidity and mortality in adults and pediatric patients with SCD, nearly one third of patients do not respond. Therefore, there is a need to evaluate the role of alternative medicine for the effective management of disease.

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: 10.00 Year(s) 至 18.00 Year(s)（—）
性别: All

入选标准

•1.Students studying in the EMR School of age 10-18 years 2.Diagnosed with Sickle cell disease 3.Parents/guardians willing to provide a written informed consent for the participation of their child.
•4.Student willing to provide Assent for the participation 5.Students who had no intention of leaving the schools until the end of the study will be included in this study.

排除标准

•1.Students suffering from uncontrolled intercurrent illness or any serious infection or illness 2.student on hyper transfusion therapy 3.Previously undergone hematopoietic stem cell transplant or solid organ transplant
•Known cases of underlying chronic diseases (cardiac, renal, tuberculosis, liver disease), neurological or hereditary disease.
•5.Students with congenital abnormalities needing medical/surgical intervention 6.Refuse to take the medicine.

结局指标

主要结局

Frequency of sickle cell-related pain crises during the study period

时间窗: Baseline and 8th month

次要结局

i.severity of painful crisis (on the basis of Visual analogue score (VAS)(Baseline and 8th month)
Change in the Hemoglobin level
Change in the health-related quality of life (assessed through Short Form-12 questionnaire)(Baseline and 8th month)

研究者

发起方

Central Council for Research in Ayurvedic Sciences

申办方类型

Research institution

责任方

Principal Investigator

主要研究者

Prashant Shinde

central council for Research in Ayurvedic Sciences, New Delhi

研究点 (11)

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