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CTRI Number  CTRI/2023/07/055575 [Registered on: 24/07/2023] Trial Registered Prospectively
Last Modified On: 24/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Curative purpose]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of ayurvedic drug orally and through nasal administration in adolescent migraine. 
Scientific Title of Study   Comparative clinical study to evaluate the efficacy of aparajita siddha ghrita as pratimarsha nasya v/s shamana snehapana in ardhavbhedaka w.s.r. adolescent migraine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Namrata Nandkumar Kamble 
Designation  PG scholar 
Affiliation  padmashree dr. D Y Patil School of Ayurved and Hospital nerul navi mumbai 
Address  DY Patil School of Ayurveda , 1st floor, opd no. 7 dept. of kaumarbhritya , block no. 10 ,D.Y. Patil Vidhyanagar Sector 7, Nerul 400706 Thane Maharashtra

Thane
MAHARASHTRA
400706
India 
Phone  8087393711  
Fax    
Email  Shinen18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kalpana Dhuri 
Designation  Head of department 
Affiliation  DY Patil School of Ayurved and Hospital nerul navi mumbai 
Address  DY Patil School of Ayurved and Hospital 3rd floor, department of kaumarbhritya , block no. 10, D.Y. Patil Vidhyanagar Sector 7 Nerul 400706 Thane Maharashtra India

Thane
MAHARASHTRA
400706
India 
Phone  9321835616  
Fax    
Email  dhurikalpana34@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kalpana Dhuri 
Designation  Head of department 
Affiliation  DY Patil School of Ayurved and Hospital nerul navi mumbai 
Address  DY Patil School of Ayurved and Hospital , 1st floor , opd no. 7, block no. 10. D.Y. Patil Vidhyanagar Sector 7 Nerul 400706 Thane Maharashtra India

Thane
MAHARASHTRA
400706
India 
Phone  9321835616  
Fax    
Email  dhurikalpana34@gmail.com  
 
Source of Monetary or Material Support  
DY patil school of Ayurveda, DY patil University  
 
Primary Sponsor  
Name  Dr Namrata Nandkumar Kamble 
Address  DY Patil School of Ayurved and Hospital DY Patil Vidyanagar sector 7 Nerul 400706 
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 Namrata Nandkumar Kamble  DY Patil School of Ayurveda  1 st floor , opd no. 7 Department of kaumarbhritya , DY Patil vidhyanagar , sector 7 , Nerul - 400706
Thane
MAHARASHTRA 		 8087393711

Shinen18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Comittee School of Ayurveda D.Y. Patil Deemed to be University, Nerul, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G43C||Periodic headache syndromes in child or adult. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Aparajita, Reference: Yogratnkar, Route: Oral, Dosage Form: Ghrita, Dose: 7(ml), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: charak samhita, Procedure details: Dip a distal part of little finger in ghruta & insert into one nostril while other is closed after taking sitting or sleeping posture. repeat the same for other nostril.)
(1) Medicine Name: Aparajita, Reference: yogratnakar, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: hs, Duration: 90 Days
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  - A diagnosis of migraine with aura and migraine without aura
- children having throbbing headache, sensitivity to light, sound, irritable, moody, nausea/vomiting
- children fulfilling the ped MIDAS criteria for diagnosis of adolescent migraine. 
 
ExclusionCriteria 
Details  - children not fulfilling the ped MIDAS criteria for diagnosis of adolescent migraine.
- known case of C.P. , M.R. and epilepsy, sleep disorder.
- known case of hearing deficit  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief from subjective assesment criteria i.e. clinical sings & symptoms of ardhavbhedaka such as ardha murdha (half sided headache) , frequency , prakash asahtva (photophobia) , dhwani asahatva (phonophobia), bhrama (giddiness), shirataap ( local temperature), chardi ( vomitting  Base line , after 15 days for 90 days trial 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   14/08/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is open   randamise , clinical  interventional type of study  compairing the efficacy of Aparajita siddha ghrita as Pratimarsha Nasya  for onece in a day at night time. v/s Shamana snehapana  for twice a day in Ardhavbhedaka for 90 days in total 60 patients with patients having symptoms of ardhavbhedaka. that will be conducted in DY Patil university school of Ayurveda Nerul Navi Mumbai and patients will be selected from opd, ipd od DY Patil Ayurvedic Hospital Nerul. 
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