A Clinical Study To Evaluate The Efficacy Of Dashmool Ghrita Nasya And Pathyadi Kwath In The Management Of Ardhavabhedak With Special Reference To Migraine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Frequency,intensity,type of Headache
研究概览
简要总结
AIM &OBJECTIVES
To evaluate the efficacyof Dashmool ghrit Nasya and Pathyadi Kwath inmanagement for Ardhavabhedaka (Migraine).
To compares the effectof only Pathyadi Kwath in the management of Ardhavabhedaka.
STUDY DESIGN:
This study will be designed as a RandomizedControlled clinical study and the participants will be selected from simplepurposive sample technique.
GROUPING:
All the 40 patients of randomly selected will bedivided into 2 groups having 20patients in each group.
GROUP - A: Intervention Group
20 patients of this group will be advised Dashmool ghrita Nasya and Pathyadi kwath 40 mltwice a day for 21 days.
GROUP - B: Control Group
20 patients of this group will be keptwith Pathyadi kwath 40 mltwice a day for 21 days.
Study duration- 21 Days
Follow up– 1 month
CRITERIA FOR DIAGNOSIS :
The diagnosis of the disease will be mainlybased on the signs and symptoms mentioned
in Ayurveda texts and the modern texts.
Headache has at least two of the following fourcharacteristics:-
• Unilateral site.
• Pulsating quality
• Moderate or severe pain intensity
• Aggravation by routine physical activity(eg.walking or Climbing etc)
During headache at least one of the followingSymptoms should be there:-
• Nausea /vomiting
• Photophobia /Phonophobia
• Headache attack lasting 4-72 hours
• Frequency of attacks 15 days per month.
INVESTIGATION:
• Complete Hemogram
CRITERIA FOR ASSESMENT
The disease is assessed by graded according toHIT- 6Tm. test (Headache impact test) Result will be assessed before and afterthe treatment on the basis of gradations.
TREATMENT REGIMEN
| Procedure |
Duration
Drug
DOSE
TIME
|Marsh nasya
1-21 days
(7 Days +1 day rest + 7 days + 1 day rest + 5 days Nasya)
Dashmool Ghrita
8 bindu in each nostril
morning
|Shaman Aushadh
1-21 days
Pathyadi Kwath
40 ml Twice a day
Before meal
HYPOTHESES
NULL HYPOTHESIS -
H0 : Group A (Dashmool ghrita Nasyaand Pathyadi Kwath)and group B Pathyadi Kwathare equally effective in themanagement of Ardhavavbhedaka(Migraine).
ALTERNATE HYPOTHESIS -
Ha1- Group A (Dashmool ghrita Nasyaand Pathyadi Kwath)is more effective than group B
Pathyadi Kwathin the management of Ardhavavbhedaka(Migraine).
Ha2- Group B Pathyadi Kwathismore effective than group A (Dashmool ghrita Nasyaand Pathyadi Kwath)in the management of Ardhavavbhedaka(Migraine).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient’s between 20 to 60 year of age.
- •2.Patients with signs and symptoms of Ardhavabhedaka according to the Ayurveda Classics and modern text.
- •3.Disease chronicity in between 5 years.
- •4.Patient who fulfill under the Diagnostic criteria.
- •5.Patients those fit for Nasya Karma.
- •6.Patients who have given written consent to participate in the study.
- •7.Standard operative procedure of covid-19 pandemic will be adopted in all patients.
排除标准
- •1.Patient’s age below 20 years and above 60years.
- •2.Patients having referred pain in one half of head due to pathology of eye, ear, nose, throat, teeth will be excluded.
- •3.Patients having any other systemic pathology like renal failure, TB, heart disease etc will be excluded.
- •4.Patients having complicated migraine and other neurological disorders.
- •5.Head Injury 6.Childhood headache 7.Headache due to Benign/malignant, growth 8.Lactating and Pregnant women’s.
- •9.Patients who are not willing to written consent to participate in the study.
结局指标
主要结局
Frequency,intensity,type of Headache
时间窗: 21 days
次要结局
- Headache has at least two of the following four characteristics:-(• Unilateral site.)