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CTRI Number  CTRI/2022/08/044781 [Registered on: 22/08/2022] Trial Registered Prospectively
Last Modified On: 17/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of Migraine through Ayurvedic line of Management  
Scientific Title of Study   A Controlled Clinical Study To Evaluate The Effect Of Shalaparni Avapidana Nasya In The Management Of Ardhavabhedaka (Migraine Without Aura) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Syed Rasool Sufiyan 
Designation  2nd Year Ms (Ayu) Scholar  
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College 
Address  Department Of Post Graduate Studies In Shalakya Tantra Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Centre Koppal

Koppal
KARNATAKA
583231
India 
Phone  8123101883  
Fax    
Email  syedrasoolsufiyan7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Veerayya R Hiremath 
Designation  Professor & Hod 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College 
Address  Department Of Post Graduate Studies In Shalakya Tantra Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Centre Koppal

Koppal
KARNATAKA
583231
India 
Phone  9448544376  
Fax    
Email  drvrh.aug15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Veerayya R Hiremath  
Designation  Professor & Hod  
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College 
Address  Department Of Post Graduate Studies In Shalakya Tantra Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Centre Koppal

Koppal
KARNATAKA
583231
India 
Phone  9448544376  
Fax    
Email  drvrh.aug15@gmail.com  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College  
 
Primary Sponsor  
Name  Department Of Shalakya Tantra 
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Centre 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Syed Rasool Sufiyan   Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Centre  Department Of Shalakya Tantra Room No 01
Koppal
KARNATAKA 
8123101883

syedrasoolsufiyan7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: (Procedure Reference: 8. Shri Govinda Dasji, Bhaishajya Ratnavali, Edited by Bhisagratna Shri Bhrahmashankar Mishra, English Translation by Dr. Kanjiv Lochan, Published by Chaukambha Sanskrit Sansthan, Varanasi, Reprint edition - 2014, Vol III, Shiroroga Adhikara, Chapter no, 65/35, page no,315., , Procedure details: Vidangadi Avapidana Nasya Each nostril 8 Bindu for 7 days))
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: (Procedure Reference: 7. Vaidya Shodhala, Gadanigraha, vidyotini hindi commentary of Sri Indradeva Tripathi, edited by Sri Ganga Sahaya Pandey, published by Chaukambha Sanskrit Sansthana Varanasi, Reprint edition - 2011, volume III chapter no,1/63, page no, 23.,, Procedure details: Shalaparni Avapidana Nasya Each nostril 8 Bindu for 7 days))
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients having the clinical features of Ardhavabhedaka (migraine without aura).
2. Patients aged between 16-60 years of either gender.
3.Patients suitable for Nasya Karma.
 
 
ExclusionCriteria 
Details  1. Patients having history of a head trauma and other type of headache.
2. Patients having any inflammatory diseases in nose, PNS, eyes and ears.
3. Patients with other systemic disorders like hypertension, diabetes mellitus etc.
• Pregnant women and lactating mothers.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Observe Reduced in headache, nausea, photophobia and phonophobia   In 7 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To Observed Complete reduction in headache, nausea, photophobia, phonophobia   In 21 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   25/08/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Ardhavabhedaka is a shiroroga1 characterized with severe sambheda (piercing), toda (pricking), shula (pain), bhrama (giddiness) in one half side of the head.  It relapses suddenly after ten days or fortnight. According to acharya Sushruta, it is tridoshaja2 and according to acharya Charaka it is vataja or vata-kaphaja3. Ayurveda emphasizes various treatment modalities of ardhavabhedaka which includes Snehana (oleation), Swedana (fomentation), virechana (purgation), Dhoopana (fumigation) and Sneha Bhojanam (unctuous food)4. Ardhavabhedaka can be co-related with migraine.

Migraine is a chronic neurological disease characterized by recurrent, moderate to severe headaches often in association with autonomic nervous system symptoms. According to International Headache Society, migraine constitutes 16% of the primary headache and affects 10-20% of the general population. It is three times more common in women than men, it is underdiagnosed and undertreated, hence WHO ranks Migraine among the World’s most disabling medical illness5. Current line of management advocates the use of analgesics and anti-emetics in acute attacks. If not responding, vasoconstrictor like Argot alkaloids are given. Sumatryptan has been used more successfully. Prophylaxis of migraine may be achieved by Topiramate, Flunarizine and Propranalol etc6.

            Even though a lot of research on migraine with different treatment modalities has been undergoing in bio-medical world, considerable number of world population  is suffering from this disease without satisfactory relief. This raises the need to explore an effective line of management for this disorder.

Shalaparni nasya7 and Vidangadi nasya8 have been mentioned for Ardhavabhedaka Chikitsa. Shalaparni is tikta madhura Rasa, guru Guna, ushna Virya, madhura Vipaka and Tridoshahara. Vidanga is katu kashaya Rasa, laghu ruksha tikshna sara Guna, ushna Virya, katu Vipaka, and Kaphavatahara in nature and Krishna Tila is madhura Rasa,  guru snigdha Guna, ushna Virya, madhura Vipaka and Tridoshahara in nature.  

Hence, present study is being taken up to evaluate the effect of Shalaparni Avapidana Nasya in the management of Ardhavabhedaka. Vidangadi Avapidana Nasya will be taken as control drug.

 
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