NEED FOR THE STUDY

Stroke is a state of decreased oxygen supply to brain cells leading to the tissue death and defined as an acute focal neurological deficit resulting from cerebrovascular disease and lasting more than 24hrs¹. Ischemic stroke is caused by thrombotic or embolic occlusion of a cerebral artery and is more common than hemorrhagic stroke².  Stroke is the second commonest cause of death in India. About 1,85,000 strokes occur every year in India with nearly one stroke every 40 seconds and one stroke death every 4 minutes In India, studies estimate that incidence of stroke population varies from 116 to 163 per 100,000 population, it is the 4th leading cause of death and 5th Leading cause of Disability Adjusted Life years (DALY) - 2016.³

Pakshaghata⁴ being one among the 80 nanatmaja vatavyadhis, is caused either by Margavarana or Dhatukshaya or Margavarana leading to Dhatukshaya. The clinical symptoms: Karma kshaya, Balahani over one Paksha looks similar to the hemiplegia / hemiparesis in contemporary medicine.

In Pakshaghata, Margavarana, Sira Snayu Shosha, Srothorodha, Sthambha, Sankocha seems to be present in every subjects.  The ischemia leading to tissue death inside the brain has to be considered Margavarana leading to Dhatukshaya⁵.The administration of anti coagulants, cerebral  activators etc., eventhough being commonly prescribed, the results are not upto the mark. The  researches upon activating the brain cells, reducing muscle rigidity and  improving motor  functions via various medical systems are going on. So research is needed.

Madhoodaka pana⁶ is medahara, Avaranaghna, Ruksha, Deepana, Lekhana pachana and vatanulomana. Sneha virechana is classical chikitsa sutra ⁷ with Payasa Eranda taila is effective in Neurotoxin deposition, neuroendocrine metabolism, anti inflammatory, analgesic, anti spasticity.  

Nasapana and nasya are transnasal administrations targetted on vyadhiadhishtana. The Mashabaladi Kashaya⁹ is a special Brumhana yoga  used for nasapana. Prachanda Bhairava rasa¹⁰, a Kajjali and

Tamra Bhasma kalpa,where in Tamra Bhasma is  Teekshna Lekhana Rasayana used generally in vascular blocks. The yoga is indicated for Kampa, Ardhanga vata, daha ,Santapa Ruja etc., Paravata kalpa¹ Prayoga is Grathitha Rakthahara, contains iron, saponins and electrolytes, antiplateletaggregating novel approach in thromboembolic stroke  which implies its anticoagulant activity. Research question is weather ayurvedic blood thinners and anti-inflammatory  approach

has any role in stroke in one arm and simple opd level rogayoga  easy approach with  ardhangavatari rasa, paravatakalpa and mashabaladitaila pratimarshanasya is effective is thought. Also two kajjali kalpas with same ingredients but different names will also be clinically studied to find their clinical effect. So set of classical  interventions or simple opd level shamana chikitsa has  combined effect in activating the brain cells, reducing muscle rigidity and improving motor functions is alternately hypothesized to bring a breakthrough in the field.

 Hence the present study entitled “AN OPEN LABELLED RCT
STUDY TO ASSESS THE COMBINED EFFECT OF NASAPANA
WITH MASHABALADIKWATHA, PRACHANDABAIRAVARASA AND PARAVATKALPA OVER MASHABALADITAILA PRATIMARSHANASYA, ARDHANGAVATARIRASA, PARAVATKALPA IN ISCHEMIC STROKE (MARGA AVARANA JANYA PAKSHAGHATA)” is taken.

HYPOTHESIS:

•        H₀- NasaPana with Mashabaladikwatha, Prachandabairavarasa & Paravat kalpa and Mashabaladi Pratimarsha nasya and Ardhangavatarirasa, Paravatkalpa in ischemic stroke has no effect.

•        H₁-Nasapana with Mashabaladikwatha, Prachandabairavarasa & Paravat kalpa and Mashabaladi Pratimarsha nasya and Ardhangavatarirasa , Paravatkalpa  in ischemic stroke has effect.           

OBJECTIVES OF THE STUDY:

1.   To assess the combined  effect of madhoodaka pana, Sadyo virechana  with payasa eranda taila, abhyanga with lashuna taila and mashabaladi kwatha nasapana, prachandabhairav rasa and Paravatakalpa in ischemic stroke.

2.   To assess the combined  effect of madhoodaka pana, Sadyo virechana  with payasa eranda taila, abhyanga with lashuna taila  and mashabaladi pratimarsha nasya and ardhangavatarirasa , paravat kalpa  in ischemic stroke .

3.  To compare the efficacy of madhoodaka pana, Sadyo virechana  with payasa eranda taila, abhyanga with lashuna taila and mashabaladi kwatha nasapana, prachandabhairav rasa and Paravata kalpa over madhoodaka pana, Sadyo virechana  with payasa eranda taila, abhyanga with lashuna taila  and mashabaladi pratimarsha nasya and ardhangavatarirasa , paravatkalpa  in ischemic stroke .

DESIGN OF STUDY:

✓    Study type – Interventional, randomized, controlled.

✓    Estimated enrolment – 40 (20 in each groups)

✓    Allocation – Randomised, two arm

✓    Masking – open labelled

✓    Primary purpose – Treatment

✓    Duration of study - 34days

✓    Followup- 14 days

ASSESSMENT CRITERIA:

Subjective parameters:

✓  Chesta nivrutthi (Motor weakness)

✓ Ruja in affected part of the body (Pain in affected part)

✓  Vaksthambha (Slurred speech)

✓  Stambha (Stiffness)

✓  Supti (Sensory loss)

✓  Mukhavakrata (Facial deviation)

GRADING FOR SUBJECTIVE PARAMETERS:

OBJECTIVE PARAMETERS:

•   Strength, bulk, tone of the muscle

•   Deep tendon reflexes.

•   superficial tendon reflexes

•   PTINR

•   Sr lithium

•   Homocysteine

   INVESTIGATIONS 

·       Hb, TC. DC. ESR, RBS, PTINR, APTT, LIPID PROFILE lft, lithium

·       CHEST X-RAY, NECK VESSEL DOPPLER, ECG, CT, MRI brain and other investigations if needed.

DATA WILL BE COLLECTED ON

Subjective parameters will be collected on

            0^TH DAY - Before treatment

            11^TH DAY- During treatment

            35^TH DAY- After treatment

            After 15 days of follow up

 Objective parameters will be collected on

            Before treatment and after treatment

OVERALL ASSESSMENT:

•        Marked relief-above 75% improvement

•        Moderate relief-51%-75% improvement

•        Mild relief -25% -50% improvement

•        No relief - 0% improvement