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CTRI Number  CTRI/2022/11/047197 [Registered on: 10/11/2022] Trial Registered Prospectively
Last Modified On: 19/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   Ayurveda medicine in the treatment of Headache 
Scientific Title of Study   Efficacy of Jyotishmati Taila Nasya in the management of Vataja Shirashula w.s.r to Tension Type of Headache - A double blinded randomised clinical trail. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BMK/21/PG/SKT/5  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shradha Adarsh Rao 
Designation  PG Scholar 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 
Address  KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Department of Shalakya Tantra OPD no 27

Belgaum
KARNATAKA
590003
India 
Phone  9284755376  
Fax    
Email  shradharao2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K S Sangolli 
Designation  Associate Professor 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 
Address  Department of Shalakya Tantra KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003 India

Belgaum
KARNATAKA
590003
India 
Phone  9448266969  
Fax    
Email  drksskle@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K S Sangolli 
Designation  Associate Professor 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 
Address  Department of Shalakya Tantra KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 590003 India

Belgaum
KARNATAKA
590003
India 
Phone  9448266969  
Fax    
Email  drksskle@gmail.com  
 
Source of Monetary or Material Support  
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya and Hospital Shahapur Belagavi 
 
Primary Sponsor  
Name  Dr Shradha Rao 
Address  PG Scholar Department of Shalakya Tantra KAHER Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi 
Type of Sponsor  Other [Self ] 
 
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 Shradha Adarsh Rao  KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi  Room no 26 Department of Shalakya Tantra
Belgaum
KARNATAKA 		 9284755376

shradharao2@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: VATAJA-SIROROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: charaka siddhi chapter 9 shloka number 99-103, Procedure details: nasya with ksheera bala taila 8 drops per nostril per day for 7 days)
(1) Medicine Name: ksheera bala taila, Reference: Sahasra yoga , taila varga, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: charaka siddhi chapter 9 shloka number 99-103, Procedure details: nasya with jyotishmati taila 8 drops per nostril per day for 7 days)
(1) Medicine Name: jyotishmati taila, Reference: raj nighantu ksheeradi varga 15/19, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a Patients presenting with classical sypmtoms of
Vataja Shira Shula and TTH
b Nasya Yogyas
 
 
ExclusionCriteria 
Details  a Nasya Ayogya Migraine and Cluster headache any
pathology involving in eyes ENT infections
b Secondary headache arising due to meningitis
tumour cervical spondylosis etc
c Pregnant lactating females old aged
d With major psychomotor disturbances eg suicidal tendencies extreme cases of depression 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Headache Disability Index
Grading for Photophobia
Headache Duration and Frequency Grading
Visual Analogue Scale 		 Baseline 7th day and 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  Nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   20/11/2022 
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="6"
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   With the rapid changes in the modern lifestyles - bad food habits, physical inactivity, wrong body posture, and disturbed biological clock, stressful and competitive times. 21st century being known as the competitive yuga adds up more to the psychosomatic disorders. Headache disorders being extraordinarily common, tension type of headache prevalence had rised upto 82% among the primary headache forms . Tension-Type Headache (TTH) are more disabling and shows more missed works than migraine . Recent studies have shown a worldwide lifetime prevalence of 46% to 78% of tension type headache . Comparing this with Vataja Shirashula mentioned in Ayurveda having similar signs and symptoms and mental factors mentioned attributing to its aetiopathogenesis, according to Acharya Charaka. Nasya being the best form for administration of medicines in all urdhwa jatrugata vikaras . Considering all this Jyotishmati Taila Nasya which has medhya and vedana shamaka karma with classical reference from Raj Nighantu, ksheeradi varga. Also studies conducted on jyotishmati proves its antinociceptive and anti-inflammatory properties , So this study has been planned. 
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