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临床试验/CTRI/2025/04/084416
CTRI/2025/04/084416尚未招募3 期

An open-label comparative clinical study to evaluate the efficacy of chinnadi kashaya in the management of ardhavabhedaka w.s.r to common migraine.

Muniyal instutute of ayurveda medical sciences,manipal,udupi.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月4日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To reduce the intensity of headache

研究概览

简要总结

Migraine is the second most common cause of headache-related & indeed neurologic cause of disability in the world, it afflicts 15% of women & 6% of men over a year.

In Ayurveda, Ardhavabhedaka can be correlated with migraines. Acharya Charaka has specifically mentioned lakshanas of Ardhavabhedaka where Vedana in Ardha part of Shirah, Manya, Bhru, Sankha, Karna, Akshi & Lalata which is said to be shastra arni - nibha shoola. If left untreated, in extreme conditions, it can lead to Nasha of Nayanam & Shrotram.

Migraine is a syndrome of episodic recurrent headache, often unilateral, which is associated with nausea, vomiting, photophobia, or phonophobia. Women are more likely to experience migraines than males (2 to 3:1).

Migraine is one of the most common reasons for people to seek medical attention. Being the most severe type of headache, migraine sometimes has dramatic features of transient neurologic deficits, blinding headaches, nausea, and vomiting.

According to the World Health Organization, migraine is the third most frequent condition in the world with an estimated global frequency of 14.7%.

Drugs like Triptans and Ergotamine Tartrate are used in the treatment of Migraine, which is expensive and not commonly used in resource-poor countries. Many adverse effects, some of which may be minor or temporary, have been reported with migraine medications.

Another problem is the overuse of medicines, which causes medication overuse headaches (MOH), further complicating management strategies. Moreover, 5HT 1B/1D receptor agonist type of drugs used in migraine are contraindicated in individuals with a history of cardiovascular & cerebrovascular diseases. The average efficacy rate of oral agents is 50-70%.

Ayurvedic treatments for migraine are often favored due to their holistic approach, which aims to address the root cause rather than just symptoms. Ayurvedic management of migraine typically involves a combination of lifestyle modifications, dietary changes, herbal supplements, and therapies to balance the bodily doshas (Vata, Pitta, and Kapha).

Therefore, a treatment that provides results with no or very few side effects is needed to improve the quality of life of patients suffering from migraines. Treatment for relief and prevention of recurrence of the disease is necessary.

Hence, in this study, an effort will be made to assess the efficacy of Chinnadi Kashaya in managing Ardhavabhedaka and its comparison with Pathyaksadhatryadi Kashaya.

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

  • Patients with classical signs and symptoms of ardhavabhedaka(Common migraine) as mentioned in diagnostic criteria.
  • Patients aged between 18 to 60 years.
  • Patients irrespective of gender, religion, or occupation.
  • patients are willing to participate in the trial.

排除标准

  • Patients prediagnosed with tension headache or any other form of headache.
  • Patients prediagnosed with meningitis, brain tumors, encephalitis, cervical spondylosis, and also headaches due to refractive errors, glaucoma, and inflammatory diseases of the ear and nose.
  • Patients prediagnosed with coronary artery disease, uncontrolled diabetes, and accelerated hypertension 4)Patients prediagnosed with any malignancy, HIV, and any other chronic diseases.
  • Pregnant and lactating women.

结局指标

主要结局

To reduce the intensity of headache

时间窗: 15 days

次要结局

  • To reduce frequency of headache, duration of headache, nausea, vomiting, photophobia, phonophobia.(30 days)

研究者

发起方
Muniyal instutute of ayurveda medical sciences,manipal,udupi.
申办方类型
Research institution and hospital

研究点 (1)

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