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临床试验/CTRI/2022/05/042700
CTRI/2022/05/042700已完成2/3 期

A randomized clinical trial on the comparative efficacy of Gandharyadi Ghrita Nasya and Dashmooladi Ghrita Nasya along with Dhatryadi Ghan Vati orally in Ardhavabhedaka with special reference to Migraine

National Institute of Ayurveda Jaipur1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年6月6日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Decrease in intensity/ duration/ frequency of headache (MIDAS/ VAS)

研究概览

简要总结

AIMS AND OBJECTIVESAim- To conduct a randomized clinical trial on comparative efficacy of Gandharyadi Ghrita Nasya and Dashmooladi Ghrita Nasya along with Dhatryadi Ghan Vati in the management of Ardhavbhedaka with special reference to Migraine.

Objectives-

1.  To study and establish a conceptual correlation between Ardhavabhedaka and Migraine.

2.  To evaluate and compare the efficacy of trial drugs in ardhavabhedaka andMigraine*.*

RESEARCH QUESTIONWhether Gandharyadi Ghrita Nasya and Dashmooladi Ghrita  Nasya  along with Dhatryadi Ghan Vati are effective in the management of Ardhavabhedaka(Migraine)?

HYPOTHESISNULL HYPOTHESIS :

H0   -There is no effect of Gandharyadi Ghrita Nasya and Dashmooladi Ghrita Nasya along with Dhatryadi Ghan Vati in Ardhavabhedaka(Migraine).

 ALTERNATE HYPOTHESIS:

H1 - There is significant difference in the effect of Gandharyadi Ghrita Nasya and Dashmooladi Ghrita Nasya along with Dhatryadi GhanVati in Ardhavabhedaka(Migraine).

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

入选标准

  • 1.Patients willing to participate in this trial through written informed consent.
  • 2.Both fresh and treated patients.
  • 3.Patients between18 to 60 years of age from either sex.
  • 4.Patients presenting with symptoms of Ardhavabhedaka vis-Ã -vis Migraine.

排除标准

  • 1.Patients of age less than 18 and greater than 60 2.Patients with referred pain in one half of head due to other secondary reasons such as anxiety, refractive errors etc.
  • rather than migraine.
  • 3.Patients with complicated Migraine like hemiplegic migraine and having any chronic debilitating disease with other neurological pathology.
  • 4.Pregnant and lactating women.
  • 5.Patients suffering from any other major systemic disorders which interfare with course of treatment.

结局指标

主要结局

Decrease in intensity/ duration/ frequency of headache (MIDAS/ VAS)

时间窗: 30 days

次要结局

  • Changes in other associated symptoms of migraine:(1.Nausea)

研究者

发起方
National Institute of Ayurveda Jaipur
申办方类型
Government medical college

研究点 (1)

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