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CTRI Number  CTRI/2022/09/045891 [Registered on: 26/09/2022] Trial Registered Prospectively
Last Modified On: 21/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Management of Ardhavbhedaka (Migraine) with Shirodhara and through Nasal Administration Procedure 
Scientific Title of Study   A Clinical Study of "Gunja Taila Nasya" and "Dashmoola Shrit Ksheera Shirodhara" in the Management of Ardhavbhedaka (Migraine) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhu 
Designation  MD Scholar 
Affiliation  Upgiasr Dsrrau 
Address  PG Department Of Panchkarma University Post Graduate Institute Of Ayurveda Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9050807620  
Fax    
Email  madhu17beniwal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gyan Prakash Sharma 
Designation  Hod & Associate Professor 
Affiliation  Upgiasr Dsrrau 
Address  PG Department Of Panchkarma University Post Graduate Institute Of Ayurveda Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9829798701  
Fax    
Email  atreyagyan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madhu 
Designation  MD Scholar 
Affiliation  Upgiasr Dsrrau 
Address  PG Department Of Panchkarma University Post Graduate Institute Of Ayurveda Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9050807620  
Fax    
Email  madhu17beniwal@gmail.com  
 
Source of Monetary or Material Support  
Dr Sarvepalli Radhakrishnan Rajasthan Ayuved University Jodhpur 
 
Primary Sponsor  
Name  Dr Sarvepalli Radhakrishnan Rajasthan Ayuved University Jodhpur 
Address  Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur Pin 342037 
Type of Sponsor  Government medical college 
 
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 Madhu  Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Hospital Of Ayurved  Opd No 7 Pg Department Of Panchkarma Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur Pin 342037
Jodhpur
RAJASTHAN 
9050807620

madhu17beniwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE INSTITUTIONAL ETHICS COMMITTEE UPGIASR JODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Navanam (Procedure Reference: Charak Siddhi , Procedure details: Nasya will be performed in the morning time for a duration of 30 minutes)
(1) Medicine Name: Gunja Taila Nasya, Reference: Bhasjhya Ratnawali, Route: Nasal, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Duration: 2 Weeks
2Intervention ArmProcedure-Kashayadhara (Procedure Reference: Dhara Kalp, Procedure details: Kashayadhara will be performed in the morning time for 45 minutes)
(1) Medicine Name: Dashmoola Shrit Ksheera Shirodhara, Reference: Bhavprakash Dravya Vargikaran, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1500(ml), Frequency: od, Duration: 2 Weeks
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Diagnosed and confirmed cases of ardhavabhedaka (migraine) according to CRF.
2.Clinically Fit for Nasya Karma and Shirodhara.
3.Patients willing to give written consent.
 
 
ExclusionCriteria 
Details  1.Patients who were suffering from secondary headaches like meningitis, brain tumor, encephalitis, cervical spondylitis, sinus, refractive errors & glaucoma.
2.Patients who were suffering from chronic disease like hypertension, COPD, renal disease etc.
3.Pregnant and lactating women.
4.A Patient of Ardhavbhedaka who was taking other treatment was excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Subjective Criteria Based On Symptoms Of Disease

Objective Criteria
Midas (Migraine Disability Assessment Test)
Visual Analogue Score (Vas)
 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the comperative efficacy of the treatment in both groups With the help of MIDAS (Migraine Disability Assessment Test),
VISUAL ANALOGUE SCORE (VAS) and Symptoms of Disease 
4 weeks 
 
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 3/ Phase 4 
Date of First Enrollment (India)   28/09/2022 
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   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Ardhavabhedaka is a disease that usually manifest in the half part of head.

In Ayurveda Ardhavabhedaka is counted in 11 types of Shirorogas. According to different Aacharyas doshas involved in Ardhavabhedaka are:-

·         Sushruta- Sannipat i.e vata pitta kapha

·         Charaka  -Vata / vata-kapha

·         Vagbhatta - Vata

 

In Modern It can be well correlated with “Migraine”. It is common neurovascular disease characterized by periodic commonly throbbing , intense headache in one half of the head , majority of times in the temporal region with some associated symptoms like nausea, vomiting, vertigo, photophobia etc. It is found in persons who are anxious, rigid, perfectionists and who work hard to fatigue themselves. In allopathy various drugs like NSAID’S Like acetaminophen, aspirin, ibuprofen, nausea medicine, triptans, Ergotamine, CGRP receptor antagonists are being used to counter the migraine. However some drugs are expensive  and producing several adverse effects like tingling, nausea, chest heaviness, fatigue, depression, insomnia, dizziness, weight gain, dry mouth etc. so we are looking to alternative system especially Ayurveda and try to find out solution for migraine. Ayurveda plays  unique role in management of the disease. Aacharya’s explained that all the Panchkarma procedures are indicated for Ardhavbhedaka. However Nasya karma and Shirodhara plays a vital role in disintegrating the pathology of the disease. The study is open labelled parallel group trial to prove the efficacy of Gunja Taila Nasya and Dashmoola Shrit Ksheera Shirodhara in the management of Ardhavabhedaka (Migraine). In one group, 15 patients will be administered with Nasya and next 15 patients will be administered with Shirodhara.

 
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