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CTRI Number  CTRI/2024/07/070896 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Nasya Process will be done]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Comparative Study To Assess The Effect of Brhihat Dashmool Tail And Pathyadi Kwath in the Management of Ardhavbhedka W.S.R To Migraine  
Scientific Title of Study   A Clinical Comparative Study To Evaluate The Efficacy Of Brihat Dashmooladi Tailam Nasya And Pathyadi Kwath In The Management Of Ardhavbhedaka w.s.r. to 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 Prerit Ahirwar 
Designation  P.G. Scholar 
Affiliation  Mansarovar Ayurvedic Medical College Hospital And Research Center  
Address  Department of Shalakya Tantra, First Floor Room number 1 Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam Kolar Road Bhopal Madhya Pradesh 462042

Bhopal
MADHYA PRADESH
462042
India 
Phone  9617029639  
Fax    
Email  preritahirwar28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arunima Namdeo 
Designation  Professor amd Head Of Department 
Affiliation  Mansarovar Ayurvedic Medical College Hospital And Research Center  
Address  Department of Shalakya Tantra, First Floor Room number 1 Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam Kolar Road Bhopal Madhya Pradesh 462042

Bhopal
MADHYA PRADESH
462042
India 
Phone  9179832716  
Fax    
Email  arunimasyadav@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prerit Ahirwar 
Designation  P.G. Scholar 
Affiliation  Mansarovar Ayurvedic Medical College Hospital And Research Center  
Address  Department of Shalakya Tantra, First Floor Room number 1 Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam Kolar Road Bhopal Madhya Pradesh 462042

Bhopal
MADHYA PRADESH
462042
India 
Phone  9617029639  
Fax    
Email  preritahirwar28@gmail.com  
 
Source of Monetary or Material Support  
Mansarovar Ayurvedic Medical College Hospital And Research Center Department Of Shalakya Tantra, First Floor Room Number 1 Mansarovar Ayurvedic Medical College Hospital And Research Centre Hinotiya Alam Kolar Road Bhopal 462042 INDIA  
 
Primary Sponsor  
Name  Mansarovar Ayurvedic Medical College Hospital And Research Center  
Address  Department Of Shalakya Tantra, First Floor Room Number 1 Mansarovar Ayurvedic Medical College Hospital And Research Center Hinotiya Alam Kolar Road Bhopal Madhya Pradesh 462042 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 Prerit Ahirwar  Mansarovar Ayurvedic Medical College Hospital And Research Center  Department Of Shalakya Tantra, First Floor Room Number 1 Mansarovar Ayurvedic Medical College Hospital And Research Center
Bhopal
MADHYA PRADESH 		 9617029639

preritahirwar28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Mansarovar Ayurvedic Medical College Hospital And Research Center  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 ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Bhaishajya Ratnavalin 65/94-98, Procedure details: In 20 patient after snehan and swedan, 6 drop of Brhiat Dashmooladi tailam will be given through nasal passage 1 time in a day upto 21 days)
(1) Medicine Name: Brihat Dashmooladi Tailam, Reference: Bhaishajya Ratnavalin 65/94-98, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 21 Days
2Comparator ArmDrugClassical(1) Medicine Name: Pathyadi Kwath , Reference: sharangdhar Samhita madhyam khand 2/143-145, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patient suffering from classical sign & symptoms of Ardhavbhedaka  
 
ExclusionCriteria 
Details  1 Patient age below 18 and above 60 years.
2. Referred pain in one half of the head due to disorder of eye, ear, nose, throat, teeth will be excluded.
3. Patient having familial hemiplegic migraine, complicated migraine and other neurological disorders.
4. Patient suffering from diabetes, tuberculosis, hypertension,
cardiovascular disease, malignancy, and or any other general debilitating health conditions.
5. Patient who needs surgical intervention.
6. Pregnant and lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
TO COMPARE THE EFFICACY OF BRIHAT DASHMOOLADI TAILAM NASYA AND PATHYADI KWATH IN THE MANAGEMENT OF ARDHAVBHEDAKA W.S.R. TO MIGRAINE  21 DAYS TREATMENT WITH 30 DAYS FOLLOWUP 
 
Secondary Outcome  
Outcome  TimePoints 
TO COMPARE THE EFFICACY OF BRIHAT DASHMOOLADI TAILAM NASYA AND PATHYADI KWATH IN THE MANAGEMENT OF ARDHAVBHEDAKA W.S.R. TO MIGRAINE  21 DAYS TREATMENT WITH 30 DAYS FOLLOWUP 
 
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 2/ Phase 3 
Date of First Enrollment (India)   01/08/2024 
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="1"
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   In present scenario due to stressful life style headache is the main problems of human beings. In Ayurveda it comes under Shiro Roga. Ardhavbhedaka is one of them in which pain occurs in head unilaterally. According to Acharya Charak, there will be severe pain in half side of the head, affecting particularly Manya, Bhru, Shakha, Karna, Akshi and Laalat. The nature of pain is like Shastra Arani Nibham. Nasya Karma is selected in this study because nasa is the appropriate route to eliminate the doshas from the Shiras and also Nasyakarma has mentioned in the management of Shiro rogas..In modern medical science we can compare it with migraine. Migraine is a special type of headache that is thought to result from abnormal vascular phenomena, although the exact mechanism is unknown. Migraine headaches often being with various prodromal sensation, such as nausea, Diminished of vision in part of the field of vision, visual aura, and other types of sensory hallucinations, In present study Brihat Dashmooladi Tail and Pathyadi Tail will be used in the managment of Ardhavbhedaka with special reference of migrain. 
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