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临床试验/CTRI/2025/01/079497
CTRI/2025/01/079497尚未招募2 期

Preclinical and Clinical evaluation of the effect of KODIVELI CHOORANAM (INTERNAL) along with SEERAGA THAILAM (EXTERNAL) in the management of SIRAKKAMBAVATHAM (CEREBRAL PALSY) in Children.

DR KAVYADHARSHINI M1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月4日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
The primary outcome of the study is to evaluate the reduction in the spasticity of muscle and improvement in movements.

研究概览

简要总结

Cerebral palsy is a non progressive neuromotor disorder of posture and movements. It is the one among the challenging disorders in the paediatric age group. The clinical features of SIRAKKAMBAVATHAM in siddha classical textbook YUGI VAITHIYA SINDHAMANI can be correlated with CEREBRAL PALSY. In classical siddha literature aathmarakshamirtha vaithiya sarasangiragam, A drug which indicates that vatha vaayu and pakkavatham can be managed by internal medicine KODIVELI CHOORANAM along with external medicine  SEERAGA THAILAM are indicated for Vatha noi in Sarabenthra vaithiyamuraigal - vatha roga sigitchai.

Considering the above explanation I have choosen KODIVELI CHOORANAM and SEERAGA THAILAM for management of Sirakkambavatham (Cerebral palsy).

OBJECTIVE:

The objective of the study is to evaluate the combined effect of KODIVELI CHOORANAM (Internal) and SEERAGA THAILAM ( External) in the management of SIRAKKAMBAVATHAM (CEREBRAL PALSY) in children.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Delay in gross motor and fine motor milestones.
  • Intellectual and cognitive functions development delay.
  • Abnormal muscle tone and reflexes.
  • Stiff and weak muscles.
  • Spastic type cerebral palsy.

排除标准

  • Status epilepticus Cerebral palsy with other associated congenital disorders Ataxic type cerebral palsy Dyskinetic cerebral palsy Mixed type cerebral palsy Autism spectrum disorder Attention defecit hyperactivity disorder.

结局指标

主要结局

The primary outcome of the study is to evaluate the reduction in the spasticity of muscle and improvement in movements.

时间窗: The outcome will be assessed after the treatment of 48 days

次要结局

未报告次要终点

研究者

发起方
DR KAVYADHARSHINI M
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr KAVYADHARSHINI M

Government siddha medical college,Palayamkottai,Tirunelveli.

研究点 (1)

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