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临床试验/CTRI/2024/12/078755
CTRI/2024/12/078755招募中2 期

An open single arm clinical trial to determine the therapeutic effect of Uloga suttigai(Metal cauterisation) in the management of Mugavatham(Bells palsy)

National institute of Siddha1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
20
试验地点
1
主要终点
Reduction in the clinical signs & symptoms of Mugavatham(Bells palsy) assessed using house brackamann scale

研究概览

简要总结

Siddhasystem of medicine is one of the ancient traditional Indian system of medicines with unique diagnostic methods, therapeutics and treatment procedures. The medicines in Siddha are classified into Agamarunthugal (Internal medicines) and Puramarunthugal (External medicines). Suttigai is one of the external therapies which includes uloga suttigai, mann suttigai, mara suttigai, kaanthi suttigai, kaal suttigai. The metals commonly used for uloga suttigai are gold, silver, copper, iron, tin. In uloga suttai the metal probe will be heated and placed in and around the diseased parts. Bell’s palsy is the most common unilateral and quick-onset peripheral paralysis of the seventh cranial nerve. Bell’s palsy could be caused by immune, infectious, or ischaemic causes, although the exact mechanism is not known. Uloga suttigai (Metal cauterization) is indicated for Mugavatham in Siddha literature. This study aims to determine the therapeutic effect of Uloga Suttigai (Metal cauterization) by assessing the reduction in clinical signs and symptoms of Mugavatham (Bell’s palsy) through House brackmann scale. 20 participants will be recruited for trial and Informed consent will be obtained from each participant. The copper suttigai instrument will be heated up to red hot and will be touched at the varma points on the affected site of face, hand, leg and on tender points along the course of facial nerve. It is done at interval of 7 days upto 5 sittings.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age: 18-60 years all genders House brackmann scale grade 2 to 6.

排除标准

  • uncontrolled diabetes mellitus pregnant and lactating women psychiatric disorders known case of malignancy.

结局指标

主要结局

Reduction in the clinical signs & symptoms of Mugavatham(Bells palsy) assessed using house brackamann scale

时间窗: Baseline,each week until 7th week

次要结局

  • Improvement in quality of life(Baseline,each week until 7th week)

研究者

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

Dr Selva priya S

National Institute of Siddha

研究点 (1)

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