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A Clinical study for Ayurvedic management of Migraine without Aura

Phase 3
Active, not recruiting
Conditions
Chronic migraine without aura,
Registration Number
CTRI/2020/06/025607
Lead Sponsor
Dr Divya Virupaksha
Brief Summary

**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 -

1. To re-evaluate the efficacy of *Marsha Nasya* with *Go Sarpi* in the management of *Ardhavabhedaka**.*

2. To evaluate the efficacy of *Pratimarsha Nasya* with *Go Sarpi* in the management of *Ardhavabhedaka*.

3. 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).

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Fresh and diagnosed cases of Migraine without aura.
  • Subjects aged between 21-60 years of age irrespective of gender, religion and occupation.
Exclusion Criteria
  • 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Relief in migraine - Reduction in MIDAS SCOREAfter Treatment (8th day), | Follow up - 1 (15th day), | Follow up - 2 (30th day) of study period
Secondary Outcome Measures
NameTimeMethod
Decrease in interval between attacks of Migraine without auraAfter Treatment (8th day), Follow up-1 (15th day), Follow up - 2 (30th day) of study period

Trial Locations

Locations (1)

Sri Sri College of Ayurvedic Science and Research Hospital

🇮🇳

Bangalore, KARNATAKA, India

Sri Sri College of Ayurvedic Science and Research Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Divya Virupaksha
Principal investigator
9611611816
myreports3@gmail.com

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