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临床试验/CTRI/2023/06/054522
CTRI/2023/06/054522尚未招募1/2 期

Comparative Clinical Evaluation of Shunthyadya Ghrita Nasya and Shirashooladivajra ras orally in Ardhavabhedaka (Migraine)

Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月7日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Assessment will be made on the basis of Subjective parameters:

研究概览

简要总结

In this trial, we are selecting the patients of Ardhavbhedaka in which we will do the intervention in 2 groups- 30 patients in each group. In one group, we will intervene with ayurvedic therapeutic procedure of nasya with shunthyadya ghrita, whereas in other group we will intervene with oral intake of ayurvedic drug Shirahshooladivajra Ras. Assessment will be done on the basis of subjective parameters and scoring will be done before and after the treatment.

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 50.00 Year(s)(—)
性别
All

入选标准

  • Patients with classical signs & symptoms of Ardhavabhedaka (Migraine) described as per ayurvedic and modern science.
  • Patients between the age group of 18 years to 50 years of either sex.
  • Patients in related group who are fit for Nasya Karma Nasya yogya vyakti.

排除标准

  • Patients less than 18 years and above 50 years of age.
  • Patients who are contraindicated for Nasya Karma.
  • Patients suffering from any other forms of headaches apart from Ardhavabhedaka (Migraine) like headaches arising due to HTN, sinusitis, meningitis, encephalitis and ocular manifestations.
  • Patient suffering from any systemic diseases like diabetes mellitus, heart disease, hypertension, cancer and receiving medication which may alter the results of study.

结局指标

主要结局

Assessment will be made on the basis of Subjective parameters:

时间窗: 0, 8 weeks, 10 weeks, 12 weeks

1. Severity of Headache.

时间窗: 0, 8 weeks, 10 weeks, 12 weeks

2. Frequency of Headache.

时间窗: 0, 8 weeks, 10 weeks, 12 weeks

3. Duration of Headache.

时间窗: 0, 8 weeks, 10 weeks, 12 weeks

4. Nausea.

时间窗: 0, 8 weeks, 10 weeks, 12 weeks

5. Vomiting.

时间窗: 0, 8 weeks, 10 weeks, 12 weeks

6. Vertigo.

时间窗: 0, 8 weeks, 10 weeks, 12 weeks

7. Aura.

时间窗: 0, 8 weeks, 10 weeks, 12 weeks

8. Photophobia.

时间窗: 0, 8 weeks, 10 weeks, 12 weeks

9. Phonophobia.

时间窗: 0, 8 weeks, 10 weeks, 12 weeks

次要结局

  • Subjective parameters:(1. Severity of Headache.)

研究者

发起方
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
申办方类型
Private medical college

研究点 (1)

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