CTRI/2024/07/071603尚未招募2/3 期
A Clinical Study To Evaluate The Efficacy Of Arq-e-Ajeeb And Nutool-e-Raas With Roghan-e- Gul And Roghan-e-Kaddu In The Management Of Shaqiqa (Migraine Without Aura).
State Unani Medical College and Hospital, Himmatganj, Prayagraj, Uttar Pradesh (211016)1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月10日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.VAS(Visual Analogue scale).
研究概览
简要总结
Shaqiqa (Migraine), the second most common cause of headache, and the most common headache-related, and indeed neurologic, cause of disability in the world. It is a recurrent attacks of headache, varied in intensity, frequency and duration; commonly unilateral in onset, and usually associated with anorexia and sometimes with nausea and vomiting. It has two major clinical subtypes:
- Migraine without aura (Common Migraine)
- Migraine with aura (Classical Migraine) Migraine without aura (Common Migraine) which occurs in about 80% to 85% of patients and migraine with aura (Classical Migraine) which occurs in about 15%to 20% of patients. The attack in classical migraine is consist of four phases : aura phase(neurological dysfunction), prodromal phase, the headache phase and a post-dromal phase. Common migraine consists of three phases: prodromal phase, headache phase and post-dromal phase. Other less common types include Hemiplegic migraine, Retinal migraine, Abdominal migraine, probable migraine, basilar migraine, chronic migraine etc. Migraine is mainly a familial disorder, and it is estimated that 5% of total population suffer from migraine. The risk factor (triggers) include glare, bright light, sound, hunger, mental stress, physical exertion, hormonal fluctuations, lack of or excess sleep, alcohol etc. Usually attacks of migraine commence in late childhood, adolescence and early twenties, more common in females between 25 to 40 years of age. Migraine is a second most common cause of headache disorder which affects the near about 12% of general population, more prevalence in women about 15% and 6% of men. It has high influence on our society due to its disabling nature,and it reduces quality of life and increases defection in work. World Health Organization (WHO) listed migraine as the 19th disability cause worldwide, and it is responsible for 1.4% of life lost due to disability in all years. According to American Headache Society Evidence in US, 1.2 million peoples visit to emergency department due to migraine.Thus, it is clear that migraine is one of leading cause of disability in adults and has high disease burden. Thus effective treatment of migraine is needed with fewer side effects. Despite having effective treatment for acute migraine attacks (such as Triptans) . The response rate varies from 44-70%. Some patients do not get relief by two hours after taking oral migraine medications, and recurrence of headache within 24 hours of initial dosing is common. In addition these medicines have adverse effects such as NSAIDs cause dyspepsia and gastrointestinal irritation; Ergotamine may cause nausea. Triptans which are considered as important medicine for acute migraine treatment are generally not effective in migraine with aura unless given after the aura is completed and the headache initiated, recurrence of headache within usual time of course of an attack occurs in most of the patients. The prophylactic agents available have limited efficacy and may cause adverse effects and not compatible for long term use. Unani Physicians have successfully treated migraine (which is called Shaqiqa in Unani) since ancient time without any significant side effects on the basis of principles of Tanqia Mawad-e- Raddia and Taqwiat-e-Dimagh achieved by using Munzij wa Mushil and Nutool, Sa’oot wa Zimad. There are multiple single and compound drugs used for the management of shaqiqa i.e., Ustukhuddus, kishneez, banafsha, zafran, sapistan, khatmi, ayarij feeqra, itrifal etc while Ilaj Bit tadbeer is a method of treatment in which some external methods and measures are used to cure the disease without the help of internal medicine. Keeping this in view, a study planned to evaluate the efficacy of Ilaj-bittadbeer in management of migraine using Nutool-e-Raas and local application of some Unani formulation of drugs. The goal of managing migraine is to reduce migraine frequency, severity and disability and to improve the quality of life. Therefore we have planned to conduct a clinical study entitled as “A Clinical Study to evaluate the efficacy of Arq-e-Ajeeb and Nutool-e-Raas with Roghan-e-Gul and Roghan-e-Kaddu in the managementof Shaqiqa (Migraine without aura).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Clinically diagnosed patients with migraine as per ICHD criteria.
- •Willing to fill daily headache diary.
- •Patient willing to sign written informed consent.
- •Patient who do report during follow-up (who follow instructions).
- •No systemic and local pathology.
排除标准
- •Patients below the age 18 years and above 60 years.
- •Non-Migrainous headache: tension type headache; cluster headache; chronic paroxysmal or non paroxysmal hemicranias.
- •Familial hemiplegic migraine
- •Any allergy related to drug used in this study.
- •Pregnancy and lactation.
- •Patients with Neuropsychiatric illness.
- •Patients with significant co-morbidity eg.
- •Glaucoma, Trigeminal neuralgia, cervical spondylosis, Seizures disorders.
- •Patients who do not report for follow up and who refuses to join the study.
- •Patients on analgesic, steroidal and hormonal therapy.
结局指标
主要结局
1.VAS(Visual Analogue scale).
时间窗: For 1st month (twice in a week) | For 2nd month (Once in a week)
次要结局
- MIDAS(Migraine Disability Assessment Scale).(HIT-6(Headache impact test-6).)
研究者
Mohd Sajid
State Unani Medical College and Hospital Prayagraj Uttar Pradesh India
研究点 (1)
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