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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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: | 2 | Comparator Arm | Drug | Classical | | (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: - | 3 | Intervention Arm | Drug | Classical | | (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: - | 4 | Comparator Arm | Drug | Classical | | (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: - | 5 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (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 Aá¹£á¹anga 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. |