临床试验/CTRI/2023/05/052162

CTRI/2023/05/052162已完成2/3 期

A Randomized Controlled Trial Of Ayurved Intervention And Contemporary Protocol In Snayugata Aghataja Shoth With Special Reference To Ankle Sprain

National Institute of Ayurveda1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2023年5月15日最近更新: 2024年10月17日

试验速览

阶段: 2/3 期
状态: 已完成
发起方: National Institute of Ayurveda
入组人数: 30
试验地点: 1
主要终点: Overall improvement in the symptoms of ankle sprain using the ayurved intervention

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

Participants attending the OPD and IPD of the NIA hospital and satisfying the selection criteria will

be selected. All the participants who voluntarily agree to participate and provide informed written

consent for participation will be recruited in the study.

Total 30 participants will be selected after details examination and divided in 2 group of 15 patients

each as per study protocol. All Procedures will be executed done under aseptic condition . Patient will be taken for follow-up

initially 5 th day ,11 th day , 21 st day ,follow up for next 3 weeks ( weekly interval ).

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 14.00 Year(s) 至 45.00 Year(s)（—）
性别: All

入选标准

•1.Patients with typical history & clinical features pertaining to Acute ankle sprain of grades I & II presented with in initial 72 hours of injury.
•2.Grade I : No laxity, minimal pain and mild swelling .
•3.Grade II : Mild to moderate laxity, soft tissue swelling, anterior drawer and talar tilt is slightly positive.

排除标准

•1.Ankle Impingement 2.Tarsal Tunnel Syndrome 3.Sinus Tarsi Syndrome 4.Cartilage or osteochondral injuries 5.Peroneal Tendinopathy or subluxation 6.Posterior Tibial Tendon Dysfunction 7.Systemic disease.
•CVS , CKD 8.Wound over ankle 9.Ankle dislocation.

结局指标

主要结局

Overall improvement in the symptoms of ankle sprain using the ayurved intervention

时间窗: Day of presentation ,5TH day ,11th day ,21st day

次要结局

To test the efficacy of the protocol developed for Ankle Sprain in terms of improvement as per Ayurvediya Preview in comparison to standard treatment protocol(3 weeks)

研究者

发起方

National Institute of Ayurveda

申办方类型

Research institution and hospital

研究点 (1)

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