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临床试验/CTRI/2024/03/063907
CTRI/2024/03/063907尚未招募不适用

“RANDOMIZED CONTROLLED CLINICAL TRIAL OF SHADBINDU TAIL NASYA AND SARIVADI LEPA IN ARDHAVABHEDAKA WITH SPECIAL REFERENCE TO MIGRAINE”

PMTs Ayurveda College Shevgaon1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
87
试验地点
1
主要终点
To evaluate efficacy of Sarivadi lepa and shadbindu tail nasya in

研究概览

简要总结

Migraine has become a global issue with global prevalence of 14.7 %. In Asian countries including India average prevalence of migraine is 14 – 20 %. In females’ prevalence rate is goes beyond 25%. Chronic migraine affects approximately 2% of the world population. Migraine and chronic headache are found to be the second most frequently identified cause of short-term absence for non-manual employees, and amongst the five leading causes of emergency department visits. Migraine remains undiagnosed and undertreated in at least 50% of patients, and less than 50% of migraine patients consult a physician . Migraine ranks sixth highest cause of the disease burden as per the years lived with disability (YLD) criteria.

In modern science there are different modalities present for the treatment of migraine, but they aren’t satisfactory as they don’t relive disease completely & providestemporary relief also chances of recurrence are more hampering patient physically, mentally & economically also. Ayurveda shows a promising way for the treatment of migraine (ardhavabhedaka). There are many shamana chikitsa & shodhana chikitsa are described in ayurveda texts.

In Ayurveda Nasya therapy is considered as one of the most promising treatment for all the urdhwajatrugat vikaras. Nasya karma involve administration of herbal oil/drugs/liquids into the nostrils which removes the blockages of the nasal pathways, reduces feeling of heaviness in head region & relief mental stress. These effect of Nasya gives significant relief in diseases associated with nose & head region such as; migraine (Ardhavbhedaka).

Shadbindu tail is proven drug in Ardhavabhedaka with efficacy of approximately 60%. Shadbindu tail is mentioned in Bhavaprakash madhyam khanda 2 shirorogadhikar and gadanigraha part 2 tail prakaran13. SARIVADI LEPA is mentioned in Sushrut Samhita Uttarsthan 26/34. It is also mentioned in SHARANGDHAR SAMHITA 3/11/23 and YOGRATNAKAR shirorog chikitsa with some modification in drugs. Sarivadi lepa is selected as add on effect on shadbindu tail to increase its efficacy. Lepa is easy for application and all drugs in this lepa are easily available and very cost effective. Till today no research has been carried out on SARIVADI LEPA.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • k/c/o Migraine/ Ardhavabhedakah Patients fulfilling diagnostic criteria of Ardhavabhedakah / Migraine will be selected randomly irrespective of sex, religion, occupation.

排除标准

  • Referred pain in one half of the head due to disordr of eye, ear, nose, throat, teeth.
  • h/o secondary headache/ IC host / malignancy / first time severe headache Patients not fulfilling diagnostic criteria Patient who was on any other medication which may interfere with trial treatment.

结局指标

主要结局

To evaluate efficacy of Sarivadi lepa and shadbindu tail nasya in

时间窗: 7 days treatment with 4 follow ups. 0,7th,14th and 30th day

ardhavabhedaka with special reference to migraine.

时间窗: 7 days treatment with 4 follow ups. 0,7th,14th and 30th day

Is there any reduction in symptoms or frequency of symptoms of migraine will be assesed after month

时间窗: 7 days treatment with 4 follow ups. 0,7th,14th and 30th day

次要结局

  • To review the details of ARDHAVABHEDAKA in ayurveda and modern.(To study LEPA Kalpana and Nasya kalpana in detail.)

研究者

发起方
PMTs Ayurveda College Shevgaon
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Omkar Ramratan Malpani

PMTs Ayurved College Shevgaon

研究点 (1)

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