A Clinical Study on Static and Increment Dosage Patterns of Lashuna Rasayana in Gridhrasi w.s.r Sciatica

Phase 3

Conditions: Health Condition 1: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy

Registration Number: CTRI/2023/06/054080

Lead Sponsor: Dr Anupama S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients of Gridhrasi/Sciatica between the age of 16 to 70 years.

2.Patients with radiological evidence of Lumbar Spondylosis.

3.Patients with radiological evidence of Disc Prolapse.

Exclusion Criteria

1.Sciatica with Congenital deformities of spine

2.Neoplastic conditions of the spine with radicular pain.

3.Infections of the spine with Sciatica.

4.Patients with evidence of severe unstable renal, hepatic, hemopoitic and cardiac disorder as revealed by history and/or investigations which would decline the general condition of the patient and interfere with the present clinical trial.

5.Those with history of having received any investigational drug in the previous one month.

6.Patients taking antipyretics, analgesics, tranquilizers, hypnotics, excessive alcohol or any other drug which would interfere with the pain perception.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change from baseline in Visual analogue scale for back pain intensity (katishula) <br/ ><br>2.Change from baseline in Visual analogue scale for leg pain intensity (sakthishula) <br/ ><br>3.Change from baseline in Visual analogue scale for leg stiffness intensity (stambha) [range 0 (better) -10 (worse); Time Frame: baseline, 18 days] <br/ ><br>4.Change from baseline in the average angle of restriction while testing straight leg raising (saktiutkshep nigraha) [if unilateral the actual degree of restriction is noted, if bilateral average degree of restriction is considered; Time Frame: baseline, 18 days] <br/ ><br>5.Change from baseline in Aberdeen back pain scale [Minimum back pain severity scale is 0, and maximum is 100%, The higher the score the greater the severity of the back pain; Time Frame: baseline, 18 days]Timepoint: 0, 18 days

Secondary Outcome Measures

Name	Time	Method
1.Change from baseline in Oswestry Disability Index [minimum score 0 %, maximum 100%; 0% equals no disability, and 100% is the maximum disability possible; Time Frame: baseline, 18 days] <br/ ><br>2.Change from baseline in Neurological Impairment Scale as per Herron & Turners Rating [Time Frame: baseline, 18 days] <br/ ><br>3.Change from baseline in Sugar baker & Barofsky Clinical Mobility Scale [Time Frame: baseline, 18 days] <br/ ><br>4.Change from baseline in Oswestry Disability Assessment Questionnaire [Time Frame: baseline, 18 days] <br/ ><br>Timepoint: baseline, 18 days