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CTRI Number  CTRI/2024/07/070188 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 06/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Goghrita Nasya and Marma Chikitsa in Migraine 
Scientific Title of Study   CLINICO-ANATOMICAL EVALUATION OF EFFECT OF GOGHRITA NASYA AND MARMA CHIKITSA IN ARDHAVABHEDAKA (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 Deepa 
Designation  PhD Scholar 
Affiliation  Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur 
Address  Department of Rachana Sharir, M.M.M.Government Ayurveda College, Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7568949554  
Fax    
Email  drdeepabohra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Kumar Sharma 
Designation  Associate Professor 
Affiliation  Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur 
Address  Department of Rachana Sharir, Post Graduate Institute of Ayurveda and Research, Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9166216760  
Fax    
Email  rksharma69jumbo@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepa 
Designation  Ph D Scholar 
Affiliation  Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur 
Address  Department of Rachana Sharir, M.M.M.Government Ayurveda College, Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7568949554  
Fax    
Email  drdeepabohra@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Ayurveda and Research, DSRRAU, Jodhpur 
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurveda and Research DSRRAU Jodhpur 
Address  Post Graduate Institute of Ayurveda and Research, DSRRAU, Jodhpur 
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 Deepa  M.M.M.Government Ayurveda College, Udaipur  OPD no 23, Department of Rachana Sharir, Udaipur
Udaipur
RAJASTHAN 		 7568949554

drdeepabohra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post Graduate Institute of Ayurved Institutional Ethics Committee  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-Marma Chikitsa (Procedure Reference: Dr. Sunil Kumar Joshi; Marma science and principles of Marma therapy; Delhi; Vani publication, first edition, Aug. 2010., Procedure details: Firstly Tila Taila will be applied and than 10-12 times pressure will be given to each Marma point once a day for duration of 2 month)
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Kaviraj Govind Das Sen, Bhaishajya Ratnavali, edited with Siddhiprada Hindi Commentary by Prof. Siddhi Nandan Mishra, Chaukhamba Subharati Prakashan, Varanasi, Edition: 2013., Procedure details: Pratimarsha Nasya of Goghrita, which involves instilling 2-2 drops of Goghrita into each nostril once a day for duration of 2 months. )
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients having symptoms of Ardhavabhedaka (Migraine) according to Ayurvedic classics as
well as modern science.
2. Patient who willing to take Nasya or Marma Chikitsa.
3. Person who will be ready to sign the consent form.
 
 
ExclusionCriteria 
Details  1.Patients below the age of 16 years and above the age of 60 years.
2. Chronic migraine and other type of primary headaches.
3. Known cases of secondary headache caused by meningitis, tumour, cervical spondylitis or
other neurological causes.
4.Patients with severe systemic disorders as uncontrolled Hypertension, Cardiac Problem,
Diabetes Mellitus, Tuberculosis, Leprosy, Paralysis, malignant disease etc.
5.Referred pain in half of head due to disorders of ear, eye, teeth, throat etc.
6.Pregnancy.
7.Use of other alternative medication during Ayurvedic treatment.
8.Any pervious kind of surgical history related to site of these Marma. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in clinical sign and symptoms like intensity of Headache, duration of Headache, frequency of headache and other associated symptoms of Migraine  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in MIDAS score and quality of life  3 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   05/08/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   The Migraine Research Foundation believes that Migraine is the third most prevalent disease in the world and the sixth most disabled disease in health. In modern science, the treatment comprises of both pharmacotherapy and non pharmacological treatment but these are not acceptable due to their drawbacks. so there arises the need for the approach from Ayurveda to manage and prevent the disease Migraine. A study will be conducted to evaluate the efficacy of Goghrita Nasya and Marma Chikitsa in the management of Ardhavabhedaka (Migraine). The study will involve 100 individuals randomly assigned to two groups: Each group will consist of 50 individuals. Group A (Goghrita Nasya): - Individuals in this group will receive Pratimarsha Nasya of Goghrita, which involves instilling 2-2 drops of Goghrita into each nostril once a day for duration of 2 months. Group B (Marma Chikitsa): - Marma Chikitsa will be administered to the individuals, targeting specific Marma points. Firstly Tila Taila will be applied and than 10-12 times pressure will be given to each Marma point once a day for duration of 2 month. 
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