SUTASHEKHARA RASA FOR ORALLY AND BRIHAT JEEVAKADYA TAILA FOR NASAL DROP FOR MIGRAINE

Phase 2

Completed

• Conditions: Patients suffering from Ardhavabhedaka

• Registration Number: CTRI/2015/06/005940
• Lead Sponsor: Institute for Post Graduate Teaching and Research in Ayurveda

Brief Summary

The present study is designed with the aim of evaluate efficacy of *RIHAT JEEVAKADYA TAILA NASYA* AND *SUTASHEKHARA RASA* in the management of *Ardhavabhedaka*(Migraine) in comparison of Fiunarizine

GroupA-Trial group:

(1)*Brihat Jeevakadya Taila Nasya**:*

Dose For *Nasya*: 6drops in each nostril.

Duration:*Nasya* willbe done for 2 sittings of seven days with the interval of 15 days after

Each sitting. Total duration one andhalf month.

(2)*Sutashekhara Rasa*:

Dose:250mg BD

Duration: one and halfmonth

Form : Tablet

Route of Administration : Oral

Anupana:*Drakshajala*

Group B control group:No.of patients maximum15

Flunarizine Tab10mg

Dose: 1 tab. HS

Duration: 45days

Form:Tablet

Route of Administration : Oral

CRITERIAFOR THE ASSESSMENT :-Theefficacy of the therapy will be assessed on the basis of subjective andobjective criteria.

Subjective:

Relief in signs and symptoms in termsof intensity, frequency, duration and no. of analgesics during attacks obtainedin the patients will be considered for the assessment. For this purpose mainsigns and symptoms is given score according to their severity. The details ofthe score adopted for the main signs and symptoms in this study will be givenin research proforma.

Objective:

Routine Examination and pain scale.

Follow up: 1  month

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-30
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.Patients in the age group 20 to 60 years, presenting with signs and symptoms of Ardhavabhedaka.
• Migraine described as per Ayurveda and modern science will be included in the study. 2.The diagnosis of the disease shall be done on the basis of clinical manifestations like recurrent attacks of headache, mostly unilateral in site, variable in intensity, frequency and duration with or without nausea, vomiting, aura and GI tract symptoms.

Exclusion Criteria

• 1.Patients suffering from any chronic debilitating disease, with other neurological pathology, E.N.T. pathology, stress headache and cases which required surgical intervention will be excluded from study.
• 2.Patients suffering from Sinusitis, Hypertension, Secondary headache caused by meningitis, tumor, encephalitis, cervical spondylitis and refractive errors will be excluded from study.
• 3.Patients using any other systemic drugs which may alter the results of study.
• 4.Patients who need psychiatric treatment will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement will be assessed on the basis of	Improvement will be assessed on the basis of | relief found in cardinal symptoms of | diseaseProgress in the signs and symptoms | based on the standard pattern will be applied | before and after treatment.
diseaseProgress in the signs and symptoms	Improvement will be assessed on the basis of | relief found in cardinal symptoms of | diseaseProgress in the signs and symptoms | based on the standard pattern will be applied | before and after treatment.
based on the standard pattern will be applied	Improvement will be assessed on the basis of | relief found in cardinal symptoms of | diseaseProgress in the signs and symptoms | based on the standard pattern will be applied | before and after treatment.
relief found in cardinal symptoms of	Improvement will be assessed on the basis of | relief found in cardinal symptoms of | diseaseProgress in the signs and symptoms | based on the standard pattern will be applied | before and after treatment.
before and after treatment.	Improvement will be assessed on the basis of | relief found in cardinal symptoms of | diseaseProgress in the signs and symptoms | based on the standard pattern will be applied | before and after treatment.

Secondary Outcome Measures

Name	Time	Method
Improvement will be assessed on the basis of	relief found in cardinal symptoms of

Trial Locations

Locations (1)

Institute for Post Graduate Training and Research in Ayurved; 🇮🇳 Jamnagar, GUJARAT, India

Institute for Post Graduate Training and Research in Ayurved

🇮🇳Jamnagar, GUJARAT, India

SHWETA MATA

Principal investigator

09408536366

shwetamatadr@gmail.com