FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064422 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 06/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management of Migraine by using Laghu Sutashekhara rasa(orally) with and without Brihata Dashmoola taila nasya(nasal drops). 
Scientific Title of Study   EFFICACY OF LAGHU SUTASHEKHARA RASA WITH AND WITHOUT BRIHATA DASHMOOLA TAILA NASYA IN THE MANAGEMENT OF MIGRAINE-AN OPEN LABELLED RANDOMIZED COMPARITIVE CLINICAL TRIAL. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Smitha G S 
Designation  M.S Scholar  
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  4th floor Department of Shalakya Tantra ITRA Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  6282133863  
Fax    
Email  smithagsmkv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr D B Vaghela 
Designation  Professor, HOD, ITRA 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  4th floor Department of Shalakya Tantra ITRA Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9825407899  
Fax    
Email  drvaghela@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr D B Vaghela 
Designation  Professor, HOD, ITRA 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  4th floor Department of Shalakya Tantra ITRA Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9825407899  
Fax    
Email  drvaghela@rediffmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Jamnagar Gujarat 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Institute of Teaching and Research in Ayurveda, Opposite Reliance Mart, Jamnagar 361008 Gujarat India 
Type of Sponsor  Research institution and hospital 
 
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 Smitha G S  Institute of Teaching and Research in Ayurveda  OPD no-4, Shalakya Tantra department, Institute of Teaching and Research in Ayurveda,Opposite B Division Police Station 361008 Jamnagar Gujarat
Jamnagar
GUJARAT 
6282133863

smithagsmkv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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
1Comparator ArmDrugClassical(1) Medicine Name: Laghu Sutashekhara Rasa, Reference: Rasa Tarangini Parishista, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Sukoshna Jala), Additional Information: -
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtanga Hridaya, Procedure details: 1.Purva Karma:  Arrangements of the materials & equipment.  Counselling of the patient.  Written consent of the patient is mandatory.  Instruct the patient to lie down in supine position with head and neck in low position.  Take a few drops of sesame oil on your palm and finger tips and do gentle face and neck massage for 2-3 minutes, then heat treatment (steam) is given over the face and neck. 2.Pradhana Karma:  After covering the eyes with clean cotton cloth, the phy)
(1) Medicine Name: Brihata Dashmoola Taila, Reference: Bhaishajya Ratnavali 65/94-98, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 37 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients in the age group 18 to 60 years, presenting with signs and symptoms of Migraine.
Chronicity of the disease up to 10 years.
The diagnosis of the disease shall be done on the basis of clinical manifestations like recurrent attack of headache, mostly unilateral in site, variable in intensity, frequency and duration with or without nausea, vomiting, aura and GI tract symptoms. 
 
ExclusionCriteria 
Details  Age less than 18 years and above 60 years.
Chronicity of the disease more than 10 years will be excluded.
Patients suffering from any chronic debilitating disease, with other neurological pathology, E.N.T. pathology, and cases which require surgical intervention will be excluded from study.
Patients suffering from sinusitis, hypertension, secondary headache caused by meningitis, tumour, encephalitis, cervical spondylitis and refractive errors will be excluded from study.
Patients using any other systematic drugs which may alter the results of study.  
 
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 
Reduction in the subjective criteria accessed.  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Prolonged effect of Ayurvedic intervention in the management of Migraine.  45 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) 14/03/2025 
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   Purpose of Research: Migraine is a neurological and a primary headache disorder. Globally, it is approximated that 15% of people are affected by Migraine. In modern science, number of medicines like anti-inflammatory, pain killer, NSAIDs etc. have been tried in the management of Migraine, but final answer to its management is yet awaited. Moreover, routine use of these drugs leads to GI tract disturbances. So, there is a great scope of research to find out a safe, potent and cost-effective line of treatment through Ayurveda in the management of Migraine.

Information on the Trial procedure and Drug: In Group A Laghu Sutashekhara Rasa, 500 mg, orally with luke warm water, thrice a day after meal for 45 days along with Brihata Dashmoola taila nasya at a dose of 6-6 drops in each nostril at morning (4 sittings, each sitting of 7 days with an interval of 3 days) will be given. In Group B: Only Laghu Sutasekhara Rasa, 500 mg, orally with luke warm water, thrice a day after meal for 45 days will be given. We assure that we will prepare formulations as per S.O.P in the pharmacy of I.T.R.A.

Description of the process: In present study, participants who will be clinically diagnosed and confirmed cases of Migraine enlisted in inclusion criteria will be enrolled. All participants will be divided into two groups by computer generated randomization technique having minimum of 15 patients in one group. Group A will be given with Laghu Sutashekhara Rasa, 500 mg orally with luke warm water thrice a day after meal along with Brihata Dashmoola taila nasya (4 sittings, each sitting of 7 days with an interval of 3 days) and Group B will be given only with Laghu Sutashekhara Rasa, 500 mg orally with luke warm water thrice a day after meals, for 45 days. Follow-up: After completion of the treatment, the patient will be followed up for 1 month at an interval of 15 days. Side Effects: We will follow closely and keep track of any unwanted effects. We may use some other medicines or stop the usage of drug to decrease the symptoms of the side effects. Results: The efficacy of the therapy will be asssessed on the basis of subjective criteria. Benefits: Project will help us to resolve the research, but future generations are likely to be benefited as to find out proper treatment protocol for the management of Migraine. Collected information from this research project will be kept confidential, all outcomes will be noted in tabular form and appropriate tests will be applied to compare the effect.
 
Close