A clinical study to see the effect of some Ayurvedic formulation in the form of nasal administration in the treatment of Vataj Shirashoola w.r.t. Headache

Phase 2/3

Not yet recruiting

• Conditions: Headache, (2) ICD-10 Condition: R51||Headache. Ayurveda Condition: VATAJA-SIROROGAH,

• Registration Number: CTRI/2021/02/031146
• Lead Sponsor: Sane guruji Arogya Kendra

Brief Summary

This study is open labelled randomised comparative clinical trial to evaluate the effect of Baladi Ghritamanada Nasya 2 drops in each nostril once a day for 7 days in comparison with Ksheerabala Taila Nasya given same as Baladi Ghritamanda Nasya in Vataj Shirashoola w.r.t. Headache. The primary outcome will be effect of Baladi Ghritamanda Nasya and Secondary outcome will be comparison between trial drug and control drug in the management of Vataj Shirashoola w.r.t. Headache.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-03
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1)patients suffering from symptoms of Vataj Shiashoola i.e. Shankha Ativedana, Bhru Ativedana, Lalat Ativedana 2)patients of age group 20 to 60 yrs 3)patients of eiter gender will be included in the study 4)patients yogya for Nasyakarma.

Exclusion Criteria

1)patients suffering from Sinusitis,systemic disorder like Hypertension, Diabetes, 2)Secondary Headache caused by Meningitis, Tumour, Encephalitis 3)Pregnancy and Lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Other subjective parameters-Severity of headache, Frequency of headache,Duration of headache	The drug will be given for 7 days.patient will be assessed before and after treatment.Total duration of study will be 18 months.
A clinical study to evaluate efficacy of Baladi Ghritamanda Nasya in Vataj Shirashoola w.r.t. Headache.	The drug will be given for 7 days.patient will be assessed before and after treatment.Total duration of study will be 18 months.
Subjective Parameters(by using grades and Visual analogue Scale)-Shankha Ativedana,Bhru Ativedana,Lalat Ativedana	The drug will be given for 7 days.patient will be assessed before and after treatment.Total duration of study will be 18 months.

Secondary Outcome Measures

Name	Time	Method
Comparision between efficacy of Baladi Ghritamanda Nasya and Ksheerabala Taila Nasya in Vataj Shirashoola w.r.t. Headahe.	Total duration of study will be 18 months

Trial Locations

Locations (1)

Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune 411028; 🇮🇳 Pune, MAHARASHTRA, India

Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune 411028

🇮🇳Pune, MAHARASHTRA, India

Vd Mahejabeen Munir Jikare

Principal investigator

9623658384

mjikare@gmail.com