跳至主要内容
临床试验/CTRI/2025/07/090976
CTRI/2025/07/090976招募中2/3 期

AN OPEN LABEL SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFECT OF GAJAPIPPALI AGNIKARMA WITH RASNADASHAMOOLA KASHAYA GHANAVATI ABHYANTARA PRAYOGA IN THE MANAGEMENT OF ARDHAVABHEDAKA VIS-A-VIS MIGRAINE

Dr Ramyashree H S1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Reduction in Serum Pituitary Adenylate Cyclase Activating Polypeptide - 38 (PACAP-38)

研究概览

简要总结

Ardhavabhedaka is characterized by Bheda (splitting type of pain), Toda (pricking type of pain), Bhrama (giddiness) and Shirashoola (headache) on half part of the cranium. It occurs once in 10 or 15 days or suddenly. Ardhavabhedaka can be correlated to migraine. Migraine affects more than one billion individuals each year across the world, and is one of the most common neurological disorders, with a high prevalence and morbidity, especially among young adults and females. Migraine headache reoccurs frequently, which is more severe and has unilateral involvement. The pain has pulsating quality, is aggravated by routine physical activities and is associated with nausea, photophobia and phonophobia. Pituitary adenylate cyclase-activating polypeptide -38 (PACAP) is one of the important mediators in the pathogenesis of Migraine. PACAP-38 causes dilatation of extracerebral vessels and Migraine attacks. It selectively activates the PAC1 receptor, which is a signaling pathway implicated in Migraine pain. Ardhavabhedaka is a Vata Dosha Pradhana condition and pain cannot occur without involvement of Vata. So Agnikarma pacify vata by virtue of its Ushna and Tikshna Guna. Pippali and Panchadhatu shalaka are the dahanopakaranas mentioned by Acharya Sushruta. Rasna dashamoola Kashaya and Pathyadi Kashaya are indicated in Ardhavabhedaka.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Subjects presenting with signs and symptoms of Ardhavabhedaka irrespective of gender, race, religion and occupation.
  • Migraine without Aura Subjects aged between 18 years to 70 years.
  • Subjects who fit for Agnikarma.

排除标准

  • Migraine with aura and other type of Headache Referred pain in one half of the head due to disorders of Eye, Ear, Nose, Throat, Teeth etc.
  • Subjects with HTN and other systemic illness.
  • Subjects on any other medications which is interfering with trial treatment.
  • Subjects under Ante-natal care and lactating women.

结局指标

主要结局

Reduction in Serum Pituitary Adenylate Cyclase Activating Polypeptide - 38 (PACAP-38)

时间窗: 22 Days

次要结局

  • Reduction in Bheda, Toda, Bhrama(Reduction in Ardha Shirashoola)

研究者

发起方
Dr Ramyashree H S
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Dr Ramyashree H S

JSS Ayurveda Medical College and Hospital, Mysuru

研究点 (1)

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