Evaluation of the effect of Vatagajankusha Rasa over Ekangaveera Rasa after virechana in the management of Pakshaghata (Hemiplegia): A Randomised Controlled Clinical Trial

RESEARCH QUESTION

What will be the therapeutic efficacy of Vatagajankusha rasa in comparison with Ekangaveera rasaafter Virechana in the management of Pakshaghata (Hemiplegia) for a period of 6 weeks?

HYPOTHESIS

There is a difference in therapeutic outcomes between Vatagajankusha rasa and Ekangaveeraa rasa after Virechana in the management of Pakshaghata over a 6-week treatment phase.

NULL HYPOTHESIS (H0)

No significant difference in the therapeutic efficacy of Vatagajankusha rasa and Ekangaveeraa rasa in the management of Pakshaghata (Hemiplegia).

ALTERNATE HYPOTHESIS (H1)

Therapeutic efficacy of Vatagajankusha rasa is more than Ekangaveera rasa in the management of Pakshaghata (Hemiplegia).

 AIM

To provide post-stroke patients with the possibilities of

Changes in NIHSS score

Reduction in Signs and symptoms of stroke

To improve the Quality of life in post stroke patients.

Objectives

Primary objective

To determine the effect of Vatagajankusha rasa over Ekangaveera rasa to find changes in the NIHSS score**.**

Secondary objective

To assess the improvement in the clinical signs and symptoms of Pakshaghata

To find changes in

Modified Rankin Scale (MRS) and

Modified Ashworth score

Quality of life.

Sample size calculation  . The present study is designed to evaluate the changes in NIHSS. MAS and MRS scores among patients of Pakshaghata receiving two different interventions. Based on prior literature and clinical expectations, it is assumed that there will be a meaningful difference in outcomes between the two intervention groups. Using the standard formula for calculating sample size for comparing two independent means

n is 44 in each group. After considering 10 percent dropouts rate, the final sample size will be 98(49 subjects in each group).

Considering feasibility constraints, treatment complexity, and budget limitations, it is not practical to enroll such a large sample size. Therefore, a total of 30 patients will be included in the study, with 15 patients allocated to each group.

Selection Criteria

Inclusion Criteria

Patients with the signs and symptoms of Pakshaghata (Hemiplegia).

Chronicity, up to 3 years.

NIHSS score up to 16

Ischemic stroke.

Subjects aged 21 to 60 years.

Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures**.**

Exclusion Criteria

Does not sign informed consent or refuses to cooperate with treatment.

Patients not meeting the diagnostic criteria

Diagnosed cases of intracranial hemorrhage, intracranial space occupying lesion, Congenital defects, carcinoma, basal ganglia infarct, and intracranial infections.Comatose and unconscious patients.

Hemorrhagic stroke

Pregnant women, lactating mothers.

Systemic illness, uncontrolled HTN (more than 160 by 90 mmHg), CKD, uncontrolled T2DM (HbA1C greater than 8 %)

Diagnostic Criteria

Investigation required for allocation in a clinical trial

The NCCT Head to diagnose the type of stroke (Hemorrhagic stroke will be excluded)

Assessment Criteria

Subjective Criteria

Symptoms of stroke

1.     Paralysis

2.     Difficulty with locomotion

3.     Rigidity or Flaccidity

4.     Spasm

5.     Numbness

6.     Headache

7.     Difficulty in speech

8.     Pain in either half of the body

9.     Incontinence or retention of urine

10.  Incontinence or retention of Motion

11.  Facial Palsy

Objective Criteria

NCCT Head

Signs of Stroke Exact parameters as per MRS, MAS, and NIHSS scales

Investigations (Before and After Treatment)

CBC, LFT, RFT (As routine investigation), ESR, CRP (Inflammatory markers), Vit D,

Vit B12(To pre access reversible causes of stroke), Lipid profile, HbA1C, TFT (Stroke Risk factor)

Urine R and M (To rule out underlying infection)

PARAMETERS FOR ASSESSMENT OF STUDY OUTCOMES

Subjective assessment criteria

Assessment was done based on the improvement in the symptoms of Pakshaghata like Cheshta Nivritti, Vakstambha, Hataeka paksha, and Ruk

Changes in QOL SF 36 scale

Objective assessment criteria

Changes in NIHSS score (Annexure 3)

Changes in Modified Rankin (MRS scale) (Annexure 4)

Changes in Modified Ashworth score (MAS scale) (Annexure 5)

Primary End point

A change in NIH Stroke Scale

Secondary End point

Changes in the modified Rankin Scale (mRS) .

Changes in the Modified Ashworth Scale (MAS).

Improvement in the quality of life of the patient.

Improving the clinical signs and symptoms of Pakshaghata.

Follow up: After 4 weeks of intervention.

Assessment period

1st

2nd

3rd

|BT

After virechana

After Follow up

|On day 1

ON day 57

On day 85

Posology

Group 1

Group 2

|Drug

Vatagajankusha rasa

Ekangaveeraa rasa

|Dose

250mg, BD

250mg, BD

|Anupana

Bruhat Manjishthadi kwatha 30ml

Dhanadnayanadi kwatha 30ml

|Route of administration

Oral, after breakfast and dinner

Oral, after breakfast and dinner

|Duration

6 weeks

6 weeks