Ayurveda nasal therapy with 2 ayurveda formulations-Brihat Dashamoola Taila & Shatahvadi Taila in Migraine headache

Not yet recruiting

• Conditions: Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH,

• Registration Number: CTRI/2022/03/040999
• Lead Sponsor: Sri Vijayamahanthesha Ayurveda Medical College Ilkal

Brief Summary

TITLE OF STUDY:-  “A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF *BRIHAT DASHAMOOLA TAILA NASYA* AND *SHATAHVADI  TAILA  NASYA*  IN  THE  MANAGEMENT  OF  *ARDHAVABHEDAKA*  W.S.R  TO  MIGRAINE ’’

INTRODUCTION:



*Ardhavabhedaka* is one of the *Shiro rogas* mentioned by our *Acharyas*. Symptoms are like *Ardha Parshwa shiro vedana*, *Pakshahath-Dashahath-Akasmath vedana*, *Bheda-todavath* and *Bhrama*. It is mentioned as *Tridosaja* by *Acharya Sushrutha*, *Vata/Vata-kaphaja* by *Acharya Charaka* , and *Vataja* by *Acharya Vagbhatta* .



*Ardhavabhedaka* can be compared to Migraine. Migraine –recurrent attacks of headache, varied in intensity, frequency, and duration; commonly unilateral in onset, and usually associated with anorexia and sometimes with nausea and vomiting.



According to International Headache Society (I.H.S), Migraine is the most common neurovascular headache. The life time prevalence of migraine is about 20% of females and 6% of males. The negative impact of migraines on quality of life, families and even work productivity is significant and often underrated as a serious complication. It is managed with NSAIDS, Triptans, ergot derivatives, anti-nausea drugs like Metaclopramide and cortico-steroids but, these are less acceptable due to their drawbacks and side-effects. Hence, this arise the need to explore an effective line of management for Migraine.



*Nasyakarma* is selected in this study because *nasa* is the appropriate route to eliminate the *doshas* from the *shiras* and also *Nasyakarma* has mentioned in the management of *Shiro rogas*.



For this condition, *Brihat Dashamoola Taila* and *Shatahvadi taila* have been selected for *Nasya karma.* All drugs of this *taila* are easily available and it is having qualities like *katu, tikta, ushna,teekshna* ,acts as *urdhwabhaga dosha hara* , *vata-kapha hara* and *shulagna.*



Considering all these factors the study with above mentioned medicines are selected and entitled as “A comparative clinical study to evaluate the efficacy of *Brihat Dashamoola Taila nasya* and *Shatahvadi taila Nasya* in the management of *Ardhavabhedaka* w.s.r to Migraine.â€



OBJECTIVES OF THE STUDY:



1. To evaluate the efficacy of *Brihat Dashamoola Taila Nasya* in the management of *Ardhavabhedaka*.



2. To evaluate the efficacy of *Shatahvadi Taila Nasya* in the management of *Ardhavabhedaka*.



3. To compare the efficacy of *Brihat Dashamoola Taila Nasya* and *Shatahvadi Taila Nasya* in the management of *Ardhavabhedaka.*



HYPOTHESIS :



H0 : There is neither effect of *Brihat Dashamoola Taila Nasya* nor *Shatahvadi Taila Nasya* in *Ardhavabhedaka*.



H1 : *Brihat Dashamoola Taila Nasya* has significant effect than *Shatahvadi Taila Nasya* in *Ardhavabhedaka.*



H2 : *Shatahvadi Taila Nasya* has significant effect than *Brihat Dashamoola Taila Nasya* in *Ardhavabhedaka*.



H3 : There is significant effect of both *Brihat Dashamoola Taila Nasya* and *Shatahvadi Taila Nasya* in *Ardhavabhedaka.*



MATERIALS AND METHODS:



1 SOURCE OF DATA:



a) Subjects :



Patients diagnosed with *Ardhavabhedaka* will be selected from O.P.D & I.P.D department of *Shalakya tantra*, R.P. Karadi ayurvedic hospital, ilkal  Bagalkot(dist) after applying the inclusion and exclusion criteria’s.



b) Literary :



Literary aspect of the study will be collected from classical ayurvedic and modern texts and updated journals.



c) Selection of drugs : *Brihat Dashamoola taila* of *Bhaishajya ratnavali* reference and *Shatahvadi taila* of *Yogarathnakara* reference are used for the study.



d) Collection of the drugs : The trial drugs required for the preparation of medicine will be collected from local areas with the proper authentication by *Dravya Guna* and *Rasashastra* and *Bhaishajya Kalpana* department of SVM Ayurveda and Medical college,Ilkal.



METHOD OF COLLECTION OF DATA:-



A) STUDY DESIGN:-  Randomized comparative clinical study



B) SAMPLE SIZE: - Total 30 patients were selected and divided into 2 groups i.e 15 patient’s each.



Group A- Minimum 15 patients will receive *Brihat Dashamoola taila Nasya*



Group B- Minimum 15 patients will receive *Shatahvadi taila Nasya*



C) DIAGNOSTIC CRITERIA:- As per the Classical clinical features of *Ardhavabhedaka*



1. *Ardha murdha vedana* (Severe pain in the half-side of head)

*2. Pakshath dashahath pravruthi* (headache occurs within 15 days or 10 days)

*3. Bhrama* (giddiness)

*4. Bheda todavath vedana* (Splitting type/Pricking type of headache )



D) INCLUSION CRITERIA:- Subjects fulfilling the following conditions



1. Patients suffering from classical signs and symptoms of *Ardhavabhedaka*.



2. Irrespective of gender, between the age group of 16 to 60 years.



3. Patients fit for *Nasya karma.*



E) EXCLUSION CRITERIA:- The following subjects will be excluded from the study :



1. Anya *Shirorogas*.



2. Any other systemic disorders which will interfere the course of treatment



STUDY DESIGN INTERVENTION:



| | | | | | | |

| --- | --- | --- | --- | --- | --- | --- |

| GROUPSSAMPLE SIZETREATMENTDOSEDURATION OF TREATMENT FOLLOW-UP-PERIODTOTAL STUDY DURATION

| Group-A15 patients*Nasya* with *Brihat Dashamoola taila*8 *bindu* in each nostril7 days8th,15th , 22nd day 22 days

| Group-B15 patients*Nasya* with *Shatahvadi taila*8 *bindu* in each nostril7 days8th,15th , 22nd day 22 days



ASSESSMENT CRITERIA:-



Assessment of the condition was done based on detailed proforma adopting scoring methods of subjective parameters and objective parameters were analyzed based on the obtained data.



SUBJECTIVE PARAMETERS:



1. *Theevratha of Ardhamoordha vedana* (severity of headache)



2  *Kala Prakarsha* (Duration of headache)



3. *Bhrama* (giddiness)



4. *Hrillasa* (Nausea)



5. *Chardi* (vomiting)



OBJECTIVE PARAMETERS:



1. *Vega pravruthi* (No of attacks of headache per month)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-14
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1. Patients suffering from Classical signs and symp toms of Migraine.
• 2)Irrespective of gender, between the group of 16 to 60 years.
• 3)Patients who are fit for Nasya karma.

Exclusion Criteria

1. Other type of headaches 2) Any other Systemic disorders which will interfere the course of treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TO EVALUATE the Changes in Intensity of the pain(headache)	8th day | 15th day | 22nd day

Secondary Outcome Measures

Name	Time	Method
TO EVALUATE Changes in the reoccurrence of Migraine attack	8th day

Trial Locations

Locations (1)

Out patient department, R.P.K.Ayurveda Hospital, Ilkal(tq),Bagalkot (dist); 🇮🇳 Bagalkot, KARNATAKA, India

Out patient department, R.P.K.Ayurveda Hospital, Ilkal(tq),Bagalkot (dist)

🇮🇳Bagalkot, KARNATAKA, India

Shalini N S

Principal investigator

7337851673

nshalini524@gmail.com