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To Study the Add on effect of Ayurvedic treatment and Conventional standard medical care in post stroke cases.

Phase 2
Conditions
Health Condition 1: I633- Cerebral infarction due to thrombosis of cerebral arteriesHealth Condition 2: I678- Other specified cerebrovascular diseases
Registration Number
CTRI/2023/06/054241
Lead Sponsor
Department of Kayachikitsa
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Post stroke management cases immediately after discharge (7-30 days)

2.NIHSS score from 5-14.

3.Age 21-70 yr.

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

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

Exclusion Criteria

1.Participation in any clinical trial in the last 3 months which if the investigator seems prudent to be considered an exclusion criterion.

2.Patients with unstable vitals or uncontrolled HTN & DM

3.Patients with other malignant conditions of brain

4.Any evidence of infectious conditions

5.Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.

6.Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

7.NIHSS <5 and > 14

8.Hemorrhagic stroke

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Improvement in the signs and symptoms of stroke. <br/ ><br> <br/ ><br>â?¢Symptoms of stroke <br/ ><br>1.Paralysis/Weakness of upper limb <br/ ><br>2.Paralysis/Weakness of lower limb <br/ ><br>3.Difficulty for locomotion <br/ ><br>4.Rigidity <br/ ><br>5.Flaccidity <br/ ><br>6.Spasm <br/ ><br>7.Numbness <br/ ><br>8.Head ache <br/ ><br>9.Difficulty in speech <br/ ><br>10.Pain in either half of the body <br/ ><br>11.Incontinence / retention of urine <br/ ><br>12.Incontinence/retention of Motion <br/ ><br>13.Facial Palsy <br/ ><br> <br/ ><br>Timepoint: at presentation (Day 0), Day 15, Day 30, Day 60 & Day 90
Secondary Outcome Measures
NameTimeMethod
1.Changes in QoL, SF-36 <br/ ><br>2.CBC, ESR, LFT, RFT, Vit-D, Vit-B12, Lipid profile, RBS, TFT(If done). <br/ ><br>3.To evaluate the changes in Hamilton Anxiety Rating Scale (HAM-A) <br/ ><br>Timepoint: at presentation & Day 90
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