A Randomized Single-blind comparative clinical study to evaluate the efficacy of Marsha Nasya and Pratimarsha Nasya with Go sarpi in the management of Ardhavabhedaka with special reference to Migraine without Aura
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Relief in migraine - Reduction in MIDAS SCORE
研究概览
简要总结
Migraine is a recurrent headache disorder with intense pain that maybe unilateral (one-sided) and accompanied by nauseaor vomiting as well as photosensitivity (sensitivityto light) and phonosensitivity (sensitivity tosound). Due to similarity of the signs and symptoms Migraine can beunderstood as Ardhavabhedaka.
Common Migraine, thatis Migraine without aura, characterized by nopresence of early visual changes, dizziness, confusion, having pins orneedles in the skin sensation, forms roughly 75% of Migraine. Therefore,the common Migraine has been selected for this study.
Inthe contemporary medical system, one of the common medicines prescribed forMigraine constitute long term use of Triptans, and NSAIDs.
Ofthose taking Triptans -- patients listed sleepiness andfatigue, racing heartbeat, nausea, and difficulty of thinking as common side effects.
NSAIDs- Taking them daily can make headaches worse dueto medication overuse.
Toavoid the damage caused by them, there is a necessity for a safe effectivesimple treatment modality in Ayurveda, which the study is aiming at.
Although there aremany studies completed on Ardhavabhedaka, this study is being taken upto evaluate the treatment modality of PratimarshaNasya. In the current scenario of peoples’ routine, Pratimarsha Nasya is a patientfriendly procedure as it does not require the patient to follow classical pariharavishayas of Nasya, thereby enabling them to attend to their workwithout interruption.
SnehanaNasya is an indicated lineof treatment for Ardhavabhedaka*.* Marsha and Pratimarsha being the types of Snehana/Bruhmana Nasyaare the chosen modalities of treatment in this study.
Objectives of the study -
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To re-evaluate the efficacy of Marsha Nasya with Go Sarpi in the management of Ardhavabhedaka*.*
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To evaluate the efficacy of Pratimarsha Nasya with Go Sarpi in the management of Ardhavabhedaka.
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To compare the efficacy of Marsha Nasya and Pratimarsha Nasya with Go Sarpi in the management of Ardhavabhedaka.
HYPOTHESIS:
NULLHYPOTHESIS:
Ho: Marsha Nasya and Pratimarshanasya with Go Sarpi have equivalenteffect in management of Ardhavabhedaka(Migraine without Aura).
ALTERNATEHYPOTHESIS:
H1 : Marsha Nasya and PratimarshaNasya with Go sarpi do not haveequivalent effect in management of Ardhavabhedaka (Migraine without Aura).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Fresh and diagnosed cases of Migraine without aura.
- •Subjects aged between 21-60 years of age irrespective of gender, religion and occupation.
排除标准
- •Subjects contra-indicated for Nasya.
- •Pregnant and Lactating women.
- •Subjects with diagnosed conditions of Hemiplegic Migraine, Ocular/Retinal Migraine.
- •Subjects diagnosed with Pan-sinusitis.
- •Referred pain from ear and dental disorders, Eustachian catarrh.
- •Traumatic headaches.
- •Subjects with diagnosed Cranial tumor.
- •Headache due to systemic diseases like hypertension, hypoglycemia.
结局指标
主要结局
Relief in migraine - Reduction in MIDAS SCORE
时间窗: After Treatment (8th day), | Follow up - 1 (15th day), | Follow up - 2 (30th day) of study period
次要结局
- Decrease in interval between attacks of Migraine without aura(After Treatment (8th day), Follow up-1 (15th day), Follow up - 2 (30th day) of study period)