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CTRI Number  CTRI/2023/05/052858 [Registered on: 18/05/2023] Trial Registered Prospectively
Last Modified On: 18/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Migraine through Ayurveda 
Scientific Title of Study   A Randomized Comparative Clinical Study to Evaluate the Effect of Dashmoola Kwath Nasya and Shigru Taila Nasya along with Mundi Swarasa in the Management of Ardhavabhedaka (Migraine) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashu 
Designation  Professor 
Affiliation  Shri Krishna Government Ayurvedic College and Hospital  
Address  Room No 108 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9416553131  
Fax    
Email  drashukataria@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashu 
Designation  Professor 
Affiliation  Shri Krishna Government Ayurvedic College and Hospital  
Address  Room No 108 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9416553131  
Fax    
Email  drashukataria@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashu 
Designation  Professor 
Affiliation  Shri Krishna Government Ayurvedic College and Hospital  
Address  Room No 108 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9416553131  
Fax    
Email  drashukataria@gmail.com  
 
Source of Monetary or Material Support  
Shri Krishna Ayush University Kurukshetra Haryana 136118 
 
Primary Sponsor  
Name  Dr Monika Jangra 
Address  Shri Krishna Government Ayurvedic College and Hospital Kurukshetra 
Type of Sponsor  Other [Government Ayurvedic 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 Monika Jangra  OPD no 54, Shalakya Tantra OPD, Shri Krishna Government Ayurvedic College and Hospital Kurukshetra  Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra Haryana 136118
Kurukshetra
HARYANA 
9050294577

mj4652520@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  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-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Sushruth Chikitsa 40, Procedure details: Patient should lie down in supine position then Abhyanga with Tila Taila for 5-7 minutes and then Nadi Swedan for 3 minutes will be done. After this tip of nose should be tilted up by left middle finger or thumb of the physician. One nostril should be closed with the finger of the physician. Then Koshna Sneha in the form of Marsh Nasya with Dashmoola Kwath Nasya in doses of 6-8 bindu will be administered nasally, same procedure should be repeated in another nostril also.)
(1) Medicine Name: Dashmoola Kwath Nasya, Reference: chakkradatta 60/42, Route: Nasal, Dosage Form: Kwatha/Kashaya, Dose: 8(drops), Frequency: od, Duration: 35 Days
(2) Medicine Name: Mundi Swarasa, Reference: Sharangdhar Samhita Madhyam khand 1/17, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 25(ml), Frequency: bd, Duration: 35 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Sushruth Chikitsa 40, Procedure details: Patient should lie down in supine position then Abhyanga with Tila Taila for 5-7 minutes and then Nadi Swedan for 3 minutes will be done. After this tip of nose should be tilted up by left middle finger or thumb of the physician. One nostril should be closed with the finger of the physician. Then Koshna Sneha in the form of Marsh Nasya with Shigru Taila Nasya in doses of 6-8 bindu will be administered nasally, same procedure should be repeated in another nostril also.)
(1) Medicine Name: Shigru Tila Nasya, Reference: Bhav Prakash Guduchyadi Varga page no. 339, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 35 Days
(2) Medicine Name: Mundi Swarasa, Reference: Sharangdhar Samhita Madhyam khand 1/17, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 25(ml), Frequency: bd, Duration: 35 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients with sign and symptoms of Ardhavabhedaka (Migraine with or without aura)
2) Patients those are fit for Nasya Karma according to Ayurveda text
3) Patient willing to register for clinical study 
 
ExclusionCriteria 
Details  1) Age group <16 years and >60 years.
2) The patient having any systemic illness, like - Diabetes mellitus, Hypertension, Tuberculosis, Hypotension & fever etc.
3) Patients suffering from head injury and other type of headaches except migraine.
4) Patients Contraindicated for Nasya Karma.
5) Pregnant and lactating mothers.
6) Individuals suffering from general debilitating health condition, immunocompromised disease or on immunosuppressive drugs.
7) Patients with alcohol, opioids other drug addiction and using any other systemic drugs which may alter the result of study.
8) Patients not willing to be registered for clinical study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in Subjective Criteria of Migraine  105 days 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in sign and symptoms of Ardhavebhedaka (Migraine)
Decrease in grade of severity of disease
To see changes in subjective criteria of disease 
35 Days 
 
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)   01/07/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Headache is the most common problem experienced by the individuals. Around 40% of individuals worldwide are suffering from migraine. According to IHS (Indian Headache Society),  migraine constitute 16% of the primary headache and affects about 10-20% of general population (about 15% male and 6% female are the sufferers of the migraine). About 80% of patients have migraine without aura and 15-20% have migraine with aura. It is more common in women than in men (3:1) and family history is present in more than 60% of cases. Changing hormonal level also play a role. In the global burden of disease survey 2010 Migraine is the 3rd most prevalent and 7th leading cause of disability worldwide. In GBD 2015, it was ranked the third-highest cause of disability worldwide. The community-based prevalence of migraine in India is similar to that observed in other countries except Africa. There is no permanent treatment of migraine in modern therapy. Treatment protocol is not fixed as no unique etiology, pathogenesis and diagnosis criteria is known. Hence there is a need to develop safe, conservative treatment for migraine. This study gives importance to break the Samprapti of the disease.

In Ayurveda, the Acharyas have recognized the importance of medicines, especially of the herbal medicines. Single drug treatment was the beginning point in the therapeutic regimen. Total effects of all the ingredients in the formula rather than the action of individual drugs that plays a vital role in therapeutics. According to Acharya Sushruta tridosha is the causative factor for Ardhavabhedaka. Acharya Vagbhata and Charaka described Vata and Vata-Kapha doshas in Ardhavabhedaka. Thus the drug to be selected should mainly have Vata and Kaphahara property. Vata and Vata-Kaphahara properties of Dashmoola and Shigru is the reason behind the selection of drug amongst the medicinal heritage of traditional Indian medicine. Nasya is considered as the best procedure in all Urdhwajatrugata rogas. The Hence in present study, Nasya with Dashmoola Kwath and Shigru Taila is considered. Along with this Mundi Swarasa selected for internal administration which is recommended in Ardhavabhedaka. 

For this study total 60 patients will be taken, 30 in each group. First group will be given Dashmoola Kwath Nasya along with oral administration of Mundi Swarasa for 35 days. Second group will be given Shigru Taila Nasya along with oral administration of Mundi swarasa for 35 days.

 

 
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