FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/101755 [Registered on: 21/01/2026] Trial Registered Prospectively
Last Modified On: 21/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to compare two Ayurveda treatments for Paralysis after Ischemic stroke  
Scientific Title of Study   A Comparative Clinical Study on the Role of Virecana Karma open parenthesis Tilvaka Ghrta close parenthesis and Nasya open parenthesis Karpasasthyadi Taila close parenthesis in the Management of Paksaghata with Special Reference to Hemiplegia with Ischemic Stroke 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  P Syed Shavali 
Designation  Post graduate scholor 
Affiliation  Sri Venkateshwara Ayurvedic College and Hospital 
Address  Room no 67 2nd floor PG Dept of Panchakarma Sri Venkateshwara Ayurvedic College SVIMS Circle Tirupati

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9182515394  
Fax    
Email  syedshavali007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  K Harshavardhana Appaji 
Designation  Professor Reader and HOD  
Affiliation  Sri Venkateshwara Ayurvedic College and Hospital 
Address  Room no 65 2nd floor PG Dept of Panchakarma Sri Venkateshwara Ayurvedic College SVIMS Circle Tirupati

Chittoor
ANDHRA PRADESH
517507
India 
Phone  8099959900  
Fax    
Email  avinas123419@gmail.com  
 
Details of Contact Person
Public Query
 
Name  K Harshavardhana Appaji 
Designation  Professor Reader and HOD  
Affiliation  Sri Venkateshwara Ayurvedic College and Hospital 
Address  Room no 65 2nd floor PG Dept of Panchakarma Sri Venkateshwara Ayurvedic College SVIMS Circle Tirupati


ANDHRA PRADESH
517507
India 
Phone  8099959900  
Fax    
Email  avinas123419@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateshwara Ayurvedic College and Hospital SVIMS circle tirupati Andhrapradesh India 517501  
 
Primary Sponsor  
Name  Sri Venkateshwara Ayurvedic College and Hospital 
Address  Sri Venkateshwara Ayurvedic College and Hospital SVIMS Circle Tirupati 517501 
Type of Sponsor  Government medical 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 P Syed Shavali  sri venkateshwara ayurvedic college  PG Dept of Panchakarma Sri Venkateshwara Ayurvedic College SVIMS Circle Tirupati
Chittoor
ANDHRA PRADESH 
09182515394

syedshavali007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committe of Sri Venkateshwara Ayurvedic College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G819||Hemiplegia, unspecified. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: charaka chikitsa 28chapter 100th shloka, Procedure details: Deepana and pachana with Chitrakadivati Agnitundi vati 250 mg 3 times in a day Snehapana with karpasasthyadi tailam Saharayoga taila parakarana11 Virechana with Tilvaka Ghṛta siddha yoga )
(1) Medicine Name: Tilvaka Ghrita, Reference: charaka chikitsa 28chapter 100th shloka, Route: Oral, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 1 Days
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Sahastrayogam taila prakarana 11, Procedure details: Purva Karma Mild oil massage to face and neck Gentle fomentation swedana Pradhana Karma Main procedure Patient in supine position with head slightly extended Instillation of prescribed medicine into nostrils Gentle massage over nose forehead and cheeks Paschat Karma Postprocedure Patient expels the drug not to swallow Gandusha Dhoomapana advised)
(1) Medicine Name: karpasastyadi tailam, Reference: Sahastrayogam taila prakarana 11, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged between 20 to 65 years and all genders
Patients with signs and symptoms of Paksaghata
Patients with signs and symptoms of Ischemic stroke
Onset of disease 2 months to 3 years
Patients who are eligible for Virechana karma
Patients who are eligible for nasya karma
 
 
ExclusionCriteria 
Details  Patients below the age of 20 and above the age of 65 years
Hemorrhagic Stroke
Uncontrolled diabetes and hypertension
Malignant conditions and traumatic injuries 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Virechana with tilvaka Ghrta in Group A
To evaluate the efficacy of Virechana with tilvaka Ghrta in Group A
To evaluate the efficacy of Virechana with tilvaka Ghrta in Group A
To evaluate the efficacy of nasya with karpasASthyAdi taila IN group B

 
oth day 15th day 45th day
 
 
Secondary Outcome  
Outcome  TimePoints 
to compare the efficasy of virechana with tilvaka ghrita to the group of nasya with karpasastyadi tailam   for both groups before and after treatment and then after 1 month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   09/02/2026 
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="0"
Months="6"
Days="15" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Stroke is an acute neurologic injury occurring as a result of vascular pathological processes which manifest either as brain infarction or haemorrhage. Stroke is the second most common cause of mortality and the third most common cause of disability worldwide. General clinical features include weakness or paralysis of one half of the body, dizziness, vertigo, confusion, slurred speech, drooping of the face on one side, loss of coordination, and visual problems such as blindness or diplopia.

Stroke is broadly classified into three categories: ischemic stroke, haemorrhagic stroke, and subarachnoid haemorrhage. Ischemic stroke occurs due to blockage of a blood vessel which limits blood supply to the brain. Ischemic strokes are further divided into two groups.

Thrombotic strokes are caused by a blood clot that develops in the blood vessels inside the brain. Embolic strokes are caused by a blood clot or plaque debris that develops elsewhere in the body and then travels to the brain through the bloodstream.

The global incidence and prevalence of stroke in 2023 is approximately 25 percent, whereas ischemic stroke is 0.15 percent per one lakh population according to the American Association of Neurology. In India, the incidence and prevalence of stroke is 0.145 percent, whereas ischemic stroke is 0.049 percent per one lakh population as per the Indian Academy of Neurology.

Risk factors for ischemic stroke include high blood pressure, diabetes mellitus, hyperlipidemia, excessive alcohol intake, cigarette smoking, obesity, high plasma fibrinogen levels, and cardiac lesions such as atrial fibrillation, mitral valve prolapse, valvular stenosis, congestive cardiac failure, and infective endocarditis.

Clinical presentation of ischemic stroke commonly includes sudden onset weakness or paralysis of one side of the body. Unilateral weakness is the classical presentation of stroke and rarely of cerebral venous thrombosis. The weakness progresses rapidly and follows a hemiplegic pattern.

Speech disturbances such as dysphasia and dysarthria are common. Dysphasia indicates damage to the frontal or parietal lobe, whereas dysarthria indicates incoordination of the face, pharynx, lips, tongue, or palate.

Visual loss may occur due to unilateral optic ischemia, known as amaurosis fugax if transient, caused by impaired blood flow in the internal carotid or ophthalmic artery, leading to monocular blindness. Cerebellar involvement may present as acute ataxia with associated brainstem features such as diplopia and vertigo. Headache is common in acute ischemic stroke but is rarely a dominant feature.

Cognitive effects of stroke include dysphasia, dysgraphia, dyslexia, dyscalculia, aprosody, impaired spatial orientation, anxiety, depression, and emotional lability resulting in inappropriate crying or laughter triggered by minor emotional stimuli.

Pathophysiology of ischemic stroke depends on the degree of cerebral blood flow impairment and the duration before reperfusion. When cerebral blood flow falls from normal levels of approximately 50 ml per 100 grams of brain tissue per minute to less than 10 ml per 100 grams per minute, neuronal cell death occurs rapidly.

Between the ischemic core and normally perfused tissue lies the ischemic penumbra, a region of moderately reduced blood flow dependent on collateral circulation. Neurons in this region are hypoxic and functionally inactive but remain viable. Without reperfusion, secondary biochemical cascades occur, including glutamate release, NMDA receptor activation, sodium and calcium influx, free radical formation, and eventual neuronal destruction. This underlines the concept that time is brain.

Differential diagnosis of stroke includes space occupying lesions such as subdural hematoma, tumors, cerebral abscess, and granuloma. Multiple sclerosis may mimic stroke with hemiplegia or brainstem symptoms. Hysteria is rare but should be considered when signs are inconsistent with organic disease.

Management of ischemic stroke primarily involves tissue plasminogen activator to dissolve the clot. Time is the most critical factor. Treatment options include intravenous thrombolysis and mechanical thrombectomy. Aspirin is used as an antiplatelet agent, with other agents such as clopidogrel and dipyridamole used later.

Anticoagulants such as warfarin, apixaban, dabigatran, edoxaban, and rivaroxaban prevent clot formation and are used for long term management. Surgical options include carotid endarterectomy and carotid angioplasty with stenting.

Physiotherapy and rehabilitation include mobility training, motor skill exercises, and range of motion therapy.

In Ayurveda, Pakshaghata is an important vata vyadhi described under vataja nanatmaja vyadhi and mahavata vyadhi. It may occur due to dhatu kshaya or marga avarana. Pakshaghata refers to loss of function of one half of the body.

Nidana of Pakshaghata include ahara such as ruksha, sheeta, laghu ahara, akala bhojana, langhana, and ama. Vihara includes ati vyayama, ati prajagara, vega dharana, sheeghra yana, ati vyavaya, vishamopachara, ati dosha sravana, ati asruk sravana, ati langhana, dukha shayya, asana, diva swapna, and abhighata. Manasika nidana include chinta, shoka, krodha, and bhaya. Other causes include roga, marma abhighata, and dhatu samkshaya.

Lakshanas of Pakshaghata include loss of voluntary movement on one side of the body, loss of sensation, contracture and spasticity of limbs, falling down, affection of one side of the body, abnormalities of blood vessels and ligaments, speech impairment, looseness of joints especially the shoulder, pain, and pricking sensations.

Anubandha lakshanas include pittanubandha such as burning sensation, feverishness, and delirium, and kaphanubandha such as cold sensation, swelling, and heaviness.

Samprapti of Pakshaghata involves aggravated vata causing constriction of vessels and ligaments, leading to paralysis of one side of the body. Excessively aggravated vata within dhamanis moves in abnormal directions causing loss of function, unconsciousness, collapse, or even death.

Shamana chikitsa helps in pacifying vitiated doshas. Oral formulations include Rasnadasamooladi kwatha, Sahacharadi kwatha, Narayana taila, Prasarini taila, Rasnadi guggulu, Vatagajankusha rasa, Mahavatagajankusha rasa, Chintamani rasa, Brihat vatachintamani rasa, Laghu ananda rasa, Brahmi ghrita, Kalyanaka ghrita, Vacha ghrita, Mahapaisachika ghrita, Shankhapushpi, Ashwagandha lehyam, and Saraswati churnam.

Chikitsa sutra includes snehana and swedana, mridu shodhana, anuvasana and asthapana basti, shiro basti, abhyanga, snana, upanaha swedana, and bala taila anuvasana.

Snehana and swedana cause utkleshana and draveekarana of doshas. Virechana eliminates doshas through the gastrointestinal tract and acts on pitta, rakta, sira, and kandara. Shiras is the main adhisthana of Pakshaghata and pranavata governs higher brain functions.

Nasya karma is the principal procedure acting on urdhva jatrugata vikaras. Drugs administered through the nose reach the shira region, remove morbid doshas, and pacify vata simultaneously. Nasya with Karpasasthyadi taila produces local hyperemia of nasal mucosa, enhancing absorption. Being lipid in nature, the drug can act effectively on the central nervous system, establishing a close relationship between shiras and nasa.

Virechana is considered the best treatment for Pakshaghata. Tilvaka ghrita siddha virechana yoga is described as a safe and effective virechana formulation for Pakshaghata.

 
Close