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临床试验/CTRI/2025/03/082489
CTRI/2025/03/082489尚未招募2/3 期

Effectiveness of Multiple putaka gandharvahastadi rooksha vasti (MGR) in comparison with Single putaka gandharvahastadi rooksha vasti (SGR) on samyak rooksha lakshana and samyak nirooha lakshana in kateegraha :- A Pragmatic randomised controlled trial

VPSV Ayurveda College Kottakkal1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年3月27日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
Samyak nirūha lakṣaṇa Assessment

研究概览

简要总结

A pragmatic randomized controlled trial is planned to study the effectiveness of Multiple putaka  rooksha vasti (MGR) in comparison with Single putaka rooksha vasti (SGR) on Samyak rooksha lakshana and Samyak nirooha lakshana in Katigraha. A total of 42 participants satisfying the diagnostic criteria will be included in the study and allocated into two groups using computer-generated block randomization (sequence concealed). Participants in the trial group will receive Multiple putaka Gandharvahastaadi rooksha vasti (MGR) for a maximum of three days until they attain Samyak rooksha lakshana, whereas participants in the control group will be administered Single putaka Gandharvahastaadi rooksha vasti (SGR) for a maximum of seven days until they attain Samyak rooksha lakshana. Assessments will be conducted using Samyak nirooha lakshana and Samyak rooksha lakshana assessment proforma, Visual Analogue Scale, and Oswestry Disability Index. Additionally, the Event Evaluation Scale for rooksha lakshana and nirooha lakshana will be assessed after each putaka in both groups, while other assessments will be conducted before and after treatment in each group.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants eligible for vasti Participants who have bala after first putaka Presence of Aama Avastha on aama assessment scale Patients who falls in severe and moderate categories as per Oswestry Disability Index for Low Back Pain Participants giving informed consent.

排除标准

  • Participants with Known case of fracture or dislocation of vertebrae Participants with TB spine Participants with Deformities or congenital defects Participants with Known case of uncontrolled hypertension and Diabetes mellitus Participants with Known case of neoplasm Participants with Known case of renal disorders Participants with Pregnant and lactating women Participants with Known case of Haemorrhoids.

结局指标

主要结局

Samyak nirūha lakṣaṇa Assessment

时间窗: every day after administration of each puá¹­aka of vasti | On evening of each day of vasti

Samyak rūkṣa lakṣaṇa Assessment

时间窗: every day after administration of each puá¹­aka of vasti | On evening of each day of vasti

次要结局

  • Visual Analogue Scale(Oswestry Disability Index)

研究者

发起方
VPSV Ayurveda College Kottakkal
申办方类型
Other [Aided College]
责任方
Principal Investigator
主要研究者

Dr Mithun Prabhakar R

VPSV Ayurveda College

研究点 (1)

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