A Randomized Clinical Trial to Evaluate the Effect of Ayurvedic Nasal Drop with and without Food Preparation.

Phase 2

Completed

Conditions: Migraine. Ayurveda Condition: ARDHAVABEDAKAH,

Registration Number: CTRI/2021/03/031745

Lead Sponsor: National Institute of Ayurveda Jaipur

Brief Summary: NEED FOR STUDY

ï‚· Migraine though not a life-threatening disease but can have a devastating and disruptive effect on normal living. ï‚· Migraine sufferers experience not only excruciating pain, but social seclusion, disturbances in personal relationships and prejudices in the workplace. ï‚· At present time the allopathic painkiller medicines are given to relive the symptoms of migraine but there is no complete treatment of this disease. Infect the condition of patient versions some time and he required more medication or medicines are not effective. ï‚· Ayurveda therapy may be very useful in the prevention and management of migraine. ï‚· After the continuous treatment the frequency of migraine attacks become less and finally it is completely cured.

OBJECTIVES

Primary objective :To compare the preventive effect of Anutaila Pratimarsha Nasya with and without Badamapaka in Ardhavbhedaka w.s.r to chronic migraine

Secondary objective: To assess the withdrawal of modern drug in Ardhavbhedaka w.s.r to chronic migraine during trial.

ASSESSMENT CRITERIA For assessment of the efficacy of the trial therapy, following parameters will be adopted : 1. Intensity of pain: by Visual Analogue Scale (VAS) 2. Duration of pain: in hours 3. Frequency of Headache: in 2 weeks 4. Frequency of migraine type of Headache: in 2 weeks 5. Associated symptoms: nausea, vomiting, photophobia, vertigo, tinnitus, aura, transient loss/ blurring of vision, phonophobia, nasal discharge, sleep disturbance, stiffness of neck. 6. Frequency of allopathic painkillers which the patient taking already: in 2 week.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients willing to participate in this trial through written informed consent.
Patients between 18 to 60 years of age of either sex.
Patients fulfilling the criteria of chronic migraine and Ardhavbhedaka.
Patients who are taken modern drug for headache.

Exclusion Criteria

Secondary headaches caused by meningitis, tumors, encephalitis, head and neck trauma, trigeminal neuralgia, cervical spondylitis, refractive errors, sinusitis and other disorders of cranium, neck, eyes, ears, nose, sinuses, teeth etc.
Patients with complicated migraine like status migrainosus, hemiplegic Migraine and having any chronic debilitating disease with other neurological pathology.
Pregnant and lactating women 4.
Patients suffering from any other major systemic disorders e.g. tuberculosis, cancer, heart disease etc 5.
Lactose intolerance patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic relief in headache.	8 week

Secondary Outcome Measures

Name	Time	Method
withdrawal of modern drug in Ardhavbhedaka w.s.r to chronic migraine during trial.	8 week

Trial Locations

Locations (1): National Institute of Ayurveda
🇮🇳
Jaipur, RAJASTHAN, India
National Institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
Dr Shashi Bala Saini
Principal investigator
7340566588
shashibalasainis2@gmail.com