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CTRI Number  CTRI/2023/06/054522 [Registered on: 28/06/2023] Trial Registered Prospectively
Last Modified On: 26/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effect of Shunthyadya Ghrita Nasya and Shirashooladivajra ras orally in Ardhavabhedaka (Migraine) 
Scientific Title of Study   Comparative Clinical Evaluation of Shunthyadya Ghrita Nasya and Shirashooladivajra ras orally 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  Sangyasri negi 
Designation  PG Scholar 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  O.P.D. 3, Department of Shalakya-Tantra, Patanjali ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  8077173198  
Fax    
Email  sangyasri28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Anil Verma 
Designation  HOD and Professor 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  O.P.D. 3, Department of Shalakya-Tantra, Patanjali ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  9897298775  
Fax    
Email  dranilverma11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sangyasri negi 
Designation  PG Scholar 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  O.P.D. 3, Department of Shalakya-Tantra, Patanjali ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  8077173198  
Fax    
Email  sangyasri28@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan. Haridwar 
 
Primary Sponsor  
Name  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan. Haridwar, Uttarakhand, India 249405 
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 
Sangyasri Negi  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan  OPD 3, Department of Shalakya-Tantra, Patanjali ayurved hospital, Patanjali bhartiya ayurvigyan evam anusandhan sansthan, Phase 1, Roorkee road
Hardwar
UTTARANCHAL 		 8077173198

sangyasri28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G431||Migraine with aura. Ayurveda Condition: ARDHAVABEDAKAH, (2) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Su.chi. 40/21, Procedure details: In this procedure, we will instill drops of medication or medicated ghrita in the nostrils.)
(1) Medicine Name: Shunthyada Ghrita, Reference: Gadanigraha Trityakhand Shirorogaadhikar 1/115, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 12(drops), Frequency: od, Duration: 27 Days
2Comparator ArmDrugClassical(1) Medicine Name: Shirahshooladivajra Ras, Reference: Bhaisajyaratnavali chapter 65/55-59, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients with classical signs & symptoms of Ardhavabhedaka (Migraine) described as per ayurvedic and modern science.
2. Patients between the age group of 18 years to 50 years of either sex.
3. Patients in related group who are fit for Nasya Karma Nasya yogya vyakti. 
 
ExclusionCriteria 
Details  1. Patients less than 18 years and above 50 years of age.
2. Patients who are contraindicated for Nasya Karma.
3. Patients suffering from any other forms of headaches apart from Ardhavabhedaka (Migraine) like headaches arising due to HTN, sinusitis, meningitis, encephalitis and ocular manifestations.
4. Patient suffering from any systemic diseases like diabetes mellitus, heart disease, hypertension, cancer and receiving medication which may alter the results of study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment will be made on the basis of Subjective parameters:
1. Severity of Headache.
2. Frequency of Headache.
3. Duration of Headache.
4. Nausea.
5. Vomiting.
6. Vertigo.
7. Aura.
8. Photophobia.
9. Phonophobia. 		 0, 8 weeks, 10 weeks, 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Subjective parameters:
1. Severity of Headache.
2. Frequency of Headache.
3. Duration of Headache.
4. Nausea.
5. Vomiting.
6. Vertigo.
7. Aura.
8. Photophobia.
9. Phonophobia. 		 0,8 weeks, 10 weeks, 12 weeks. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   05/07/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   In this trial, we are selecting the patients of Ardhavbhedaka in which we will do the intervention in 2 groups- 30 patients in each group. In one group, we will intervene with ayurvedic therapeutic procedure of nasya with shunthyadya ghrita, whereas in other group we will intervene with oral intake of ayurvedic drug Shirahshooladivajra Ras. Assessment will be done on the basis of subjective parameters and scoring will be done before and after the treatment. 
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