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CTRI Number  CTRI/2021/08/035700 [Registered on: 16/08/2021] Trial Registered Prospectively
Last Modified On: 11/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of gandharvyadi ghrita nasya in migraine  
Scientific Title of Study   Randomized controlled clinical trial to evaluate the efficacy of gandharvyadi ghrita nasya in ardhavbhedaka with special reference to 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 Rachna Sharma 
Designation  PG Scholar 
Affiliation  CSMSS ayurved college kanchanwadi aurangabad 
Address  CSMSS Ayurved College ground floor OPD no.- 15 Panchakarma department Paithan Road Kanchanwadi Aurangabad Aurangabad 431002 Maharashtra India

Aurangabad
MAHARASHTRA
431002
India 
Phone  9315106056  
Fax    
Email  manojsharma2487@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ganesh Barahate 
Designation  Associate professor 
Affiliation  CSMSS ayurved college kanchanwadi aurangabad 
Address  CSMSS Ayurved College ground floor OPD no.- 15 Panchakarma department Paithan Road Kanchanwadi Aurangabad Aurangabad 431002 Maharashtra India

Aurangabad
MAHARASHTRA
431002
India 
Phone  9404109895  
Fax    
Email  ayurganesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rachna Sharma 
Designation  PG Scholar 
Affiliation  CSMSS ayurved college kanchanwadi aurangabad 
Address  CSMSS Ayurved College ground floor OPD no.- 15 Panchakarma department Paithan Road Kanchanwadi Aurangabad Aurangabad 431002 Maharashtra India

Aurangabad
MAHARASHTRA
431002
India 
Phone  9315106056  
Fax    
Email  manojsharma2487@gmail.com  
 
Source of Monetary or Material Support  
CSMSS Ayurved College Paithan road Kanchanwadi Aurangabad 431002 
 
Primary Sponsor  
Name  CSMSS ayurved college kanchanwadi aurangabad 
Address  CSMSS ayurved college paithan road kanchanwadi aurangabad 431002 Maharashtra 
Type of Sponsor  Private 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 Rachna Sharma  CSMSS ayurved hospital and research center  CSMSS ayurved hospital and research center ground floor OPD no. 15 panchakarma department paithan road kanchanwadi aurangabad Maharashtra 431002
Aurangabad
MAHARASHTRA 		 9315106056

manojsharma2487@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical commitee  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-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Shushruta samhita chikitsa sthana chapter 40 shloka 25, Procedure details: 1 After drawing the tip of nostril upwards with left index finger lukewarm gandharvyadi ghrita (80 drops) is instilled into both nostrils one after the other (with right index finger) keeping one nostril closed while the other is instilled with medicine. 2 The region of ears forehead scalp cheek nape of the neck shoulders palms & sole are massaged. 3 Patient is asked to spit out the medicine. 4 Fomentation is done until no portion of the ghrita is left behind. 5 Dhumapana with haridra & kava)
(1) Medicine Name: Gandharvyadi ghrita , Reference: Bruhat nighantu ratnakar shiroroga , Route: Nasal, Dosage Form: Ghrita, Dose: 80(drops), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Sushruta samhita chikitsa sthana chapter 40 shloka 25, Procedure details: 1 After drawing the tip of nostril upwards with left index finger lukewarm goghrita (8 drops) is instilled into both nostrils one after the other (with right index finger) keeping one nostril closed while the other is instilled with medicine. 2 The region of ears forehead scalp cheek nape of the neck shoulders palms & sole are massaged. 3 Patient is asked to spit out the medicine. 4 Fomentation is done until no portion of the ghrita is left behind. 5 Dhumapana with haridra & kavala with kosh)
(1) Medicine Name: Goghrita, Reference: Charak samhita siddhi sthana chapter 9 shloka 74 to 78, Route: Nasal, Dosage Form: Ghrita, Dose: 8(drops), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having sign and symptoms of Ardhavbhedaka
Age between 16 to 60 years with respect to both gender.
Nasya yogya patients 
 
ExclusionCriteria 
Details  Nasya ayogya
Age below 16 and above 60 years
Other types of shirodhara such as anantvata, suryavarta, pittaj shirashoola.
Patients who were suffering from secondary headache like meningitis, brain tumor, encephalitis, cervical spondylitis. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study gandharvyadi ghrita nasya 8 bindu in each nostril for 7 days in Ardhavbhedaka  7 days with follow up on 1st and 8th day 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of gandharvyadi ghrita nasya and go ghrita nasya in Ardhavbhedaka
To study nasya karma in detail.
To study Ardhavbhedaka in detail according to ayurved Samhita
To study Migraine according to modern view. 		 7 days with follow up on 1st and 8th day 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   20/08/2021 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Headache in general is one of the commonest complaint of the people seeking medical help of all the disorders that presents to the clinical headache, migraine is commonest and also the most burdensome. The migraine research foundation considers migraine is the 3rd most prevalent illness and 6th most disabling health illness in the world. Ardhavbhedaka can be scientifically correlated with migraine due to its cardinal feature half sided of the head which is also explained by commentator Chakrapani as ardha mastaka vedana and also due to its paroxysmal nature. According to Brihattrayee in ardhavbhedaka chikitsa sutra nasya karma is mainly indicated. As per Brihatnighantu ratnakar, Gandharvyadi ghrita nasya act as a good medication for the ardhavbhedaka due to properties of the gandhari and jatamansi who works on brain mainly. Hence the study is planned, to evaluate the efficacy of gandharvyadi ghrita nasya karma as shodhan in Ardhavbhedaka. 
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