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CTRI Number  CTRI/2022/06/043260 [Registered on: 14/06/2022] Trial Registered Prospectively
Last Modified On: 26/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effect of Ksheerabala Taila 7 Pratimarsh Nasya and Shirshoolaadi Vajra rasa and Pathyadi Kwath in Migraine  
Scientific Title of Study   To Evaluate the add on effect of Ksheerabala taila 7 Pratimarsh Nasya along with Shirashoolaadi Vajra Rasa and Pathyaadi Kwath in Ardhavabedaka-Migraine. An open label double Arm Randomised Clinical Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vandna 
Designation  PG scholar  
Affiliation  All India Institute of Ayurveda 
Address  Room no.502,Department of Shalakya Academic block All India Institute of Ayurveda Gautam Puri Sarita Vihar South west Delhi -110076 India

South West
DELHI
110076
India 
Phone  8527514157  
Fax    
Email  vandanagarg874@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjusha Rajagopala  
Designation  Professor and head of Department  
Affiliation  All india institute of Ayurveda 
Address  Room no.502,Department of Shalakya Academic block All India Institute of Ayurveda Gautam Puri Sarita vihar South west Delhi -110076 India

South West
DELHI
110076
India 
Phone  9560788850  
Fax    
Email  hod-shalakya@aiia.gov.in  
 
Details of Contact Person
Public Query
 
Name  Dr Manjusha Rajagopala  
Designation  Head of the department  
Affiliation  All india institute of Ayurveda 
Address  Room no.502,Department of Shalakya Academic block All India Institute of Ayurveda Gautam Puri Sarita vihar South west Delhi -110076 India

South West
DELHI
110076
India 
Phone  9560788850  
Fax    
Email  hod-shalakya@aiia.gov.in  
 
Source of Monetary or Material Support  
All India Institute Of Ayurveda Gautampuri Sarita Vihar 110076  
 
Primary Sponsor  
Name  All India Institute Of Ayurveda 
Address  All India Institute Of Ayurveda Gautam Puri Sarita Vihar New Delhi 110076 
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 Vandna Garg   All India Institute of Ayurveda   OPD No.102,hospital block,All India Institute of Ayurveda Sarita Vihar New Delhi 110076
South West
DELHI 
8527514157

vandanagarg874@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:G468||Other vascular syndromes of brainin cerebrovascular diseases. Ayurveda Condition: ARDHAVABEDAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: shirashoolaadi vajra rasa , Reference: Bhaisajyaratnavali prof .Siddhinandan Mishra commentary by kaviraj govinddas sen edited by sidhiprada chaukambha Sanskrit Sanstan 65/sirorogadhikar 52-56, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: Yes(details: jala), Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Pathyaadi Kwath, Reference: Sharangadhara Samhinta Jiwaprasad: hindi commentary by Shailja Shrivastava , Madhyama Khanda 2/143-145, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
3Intervention ArmDrugClassical(1) Medicine Name: Pathyaadi kwath, Reference: Sharangadhara Samhinta Jiwaprasad: hindi commentary by Shailja Shrivastava , Madhyama Khanda 2/143-145, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
4Comparator ArmDrugClassical(1) Medicine Name: Shirashoolaadi Vajra Rasa, Reference: Bhaisajyaratnavali prof .Siddhinandan Mishra commentary by kaviraj govinddas sen edited by sidhiprada chaukambha Sanskrit Sanstan 65/sirorogadhikar 52-56, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: jala), Additional Information: -
5Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Charaka Samhita with vidyotini Hindi Commentary by Kashinath Shastri and Gorakha Nath Chaukhambha Bharti Academy ,Varanasi Chikitsa Sthan, Procedure details: KsheerabalaTaila 7 pratimarsh Nasya in the forenoon is taken once a day in the dose of two drops in each nostrils.Kavala with Sukhoshna Jala.)
(1) Medicine Name: ksheerabaala taila, Reference: Charaka Samhita with vidyotini Hindi Commentary by Kashinath Shastri and Gorakha Nath Chaukhambha Bharti Academy ,Varanasi Chikitsa Sthan, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having sign and symptoms of Ardhavabhedak -Migraine irrespective of sex ,religion occupation .
patients willing to participate in study. 
 
ExclusionCriteria 
Details  1.Pregnant and lactating women.
2.Patients suffering from uncontrolled systemic disease with oral medicine e.g tuberculosis,
cancer, diabetes mellitus, heart disease, hypertension etc.
3.Secondary headache caused by sinusitis, meningitis, brain tumour, encephalitis, cervical
spondylitis, refrective error and increased intraocular pressure.
4.Referred pain in in one half of the head due to disorders of eye, ear, nose, throat, teeth etc.
was excluded.  
 
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 
Improvement headache and nausea in patients of Ardhavabhedaka- Migraine.   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in other symptoms of Migraine e.g vertigo, photophobia, phonophobia).
ï‚· Changes in VAS, MIDAS and HAMILTON Depression rate scale 
60days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/06/2022 
Date of Study Completion (India) 22/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
Ardhavabhedaka in which there is cutting and churning pain in half region of head, cervical region, eyebrows, temporal part, ears, eyes, and frontal head which is very much similar to migraine.  Acharaya Sushruta explained it as tridoshaj disease whereas Acharaya Charaka mentioned as Vataja or Vata-Kaphaja. And Acharaya Vagbhatta explained it as vataja disease. Ardhavabhedaka can be scientifically correlated with Migraine due to its cardinal feature ‘half sided headache’ which is also explained by commentator Chakrapani as ‘ArdhaMastakaVedana’ and also due to its paroxysmal nature.Migraine is a familiar disorder characterized by recurrent attacks of pulsatile headache usually unilateral widely variable in intensity, frequency and duration. It is the most common cause of headache which is a neurovascular disease and often associated with visual disturbances, nausea, vomiting, and hallucinations. It is a benign and reoccurring syndrome of headache associated with other symptoms of neurological dysfunction . Ayurveda emphasizes various treatment modalities for Ardhavabhedaka which includes both Shamana and Shodhana Chikitsa. In Aṣṭanga saá¹…graha – Nasa is the gateway of sira. The drug administrated through nostrils reaches Sr angataka marma then spreads in the Murdha (brain) involving Netra, Karṇa, Kaná¹­ha, Siramukha and scratches the morbid Doá¹£a in supra clavicular region and expels them from Uttamanga. Here in this study the drugs selected are Ksheerabaala Tail 7 Pratimarsh Nasya selected from Charak Samhinta which is explained in management of vatasonith. Bala has been reported to possess analgesic, anti-inflammatory and vatasamak properties.Taila is a good source of Vit E and other ingredients like magnesium, copper calcium iron,Vit B6. Goksheera contains all elements necessary for nutrition of nerves muscles tissues of the body. Ksheer have pitta samak properties predominantly in Vata Dosha.Pathyadi kwatha selected from Sharangadhara Samhinta Madhyama Khand having Ama Pachana and Pitta hara property helps in relieving headache. It pecifies Tridoshas and helpful in treatment for Urdhwajatrugata rogas. It has been indicated as Sirahsulahara and Ardhasirah rujahara.Shirashoolavajra vajra Rasa is highly effective on vatika siroroga because it contain Dasamulkvatha and which is highly effective in vata provocated disease. It is useful in managing the vitiation of all tridoá¹£ha as well as duá¹£yas i.e. rasa, rakta and act as a samana ausdhahi. So in this way all medicine either pacifies or removes the vitiated vata, Pitta and may subside the symptoms of migraine. Hence the Deepana, Anulomana and Raktaprasadaka properties may help to break the systemic pathology of Ardhavabhedaka which is being widely practiced to manage the Shiro-roga in day today.
 
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