Clinical Evaluation of Trayodashanga Guggulu, Maharasnadi Kwatha and Prasarani Taila in the Management of Gridhrasi (Sciatica)

Phase 2

Completed

• Conditions: Health Condition 1: null- Low back pain radiating to one or both lower extremities

• Registration Number: CTRI/2017/11/010574
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-05-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 53

Inclusion Criteria

1.Patients of either sex within the age between 18-65 years.

2.Low back pain radiating to one or both lower extremities (buttock and below) of >3 months but equal or less than 2 years duration.

3.Patient testing positive for Straight Leg Raising (SLR), Lasegueâ??s sign

4.Patients with a pain level of equal or greater than 2 on a scale of 0-10 (VAS)

5.MRI evidence of a herniated disc spine corresponding to the patientâ??s radicular symptoms.

6.Willing to participate in the study.

Exclusion Criteria

1.Tuberculosis of the spine / hip.

2.Ankylosing spondylosis or Fractures or secondary to fractures

3.Patients with neurological deficits like, sensory loss, foot drop, limb muscle wasting and bowel/bladder incontinence

4.Patients diagnosed as diabetes mellitus (HbA1c > 6.5 %, FBS >126 mg/dl) and complications of Diabetes Mellitus viz., neuropathy, nephropathy, retinopathy, etc.

5.Patients who have a known history of cardiovascular diseases.

6.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.

7.Inflammatory Bowel Disease, Severe Dementia, Severe Infection(s), Non-ambulatory patients Monoplegia / Paraplegia/hemiplegia.

8.Pregnant / Lactating women.

9.Patients with evidence of malignancy

10.Psychiatric diseases, Alcoholics and/or substance abusers

11.Patients who have completed participation in any other clinical trial during the past six (06) months.

12.Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Improvement in the Straight Leg Raising test â?? SLR/Lasegueâ??s sign <br/ ><br>2.Change in the visual analogue scale (VAS) for pain in last 48 hours <br/ ><br>3.Change in disease specific Ayurvedic parameters <br/ ><br>4.Change in severity of disease symptoms <br/ ><br>5.Rolandâ??Morris disability questionnaire (RDQ-23) for low back ache and <br/ ><br>sciatica <br/ ><br>Timepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
1.Improvement in MRI <br/ ><br>2.Coin Test <br/ ><br>3.Lumbar spine mobility test (LSM) <br/ ><br>4.Femoral Nerve Strech Test (FNS) <br/ ><br>5.Change in laboratory parameters and X-Ray <br/ ><br>Timepoint: 12 weeks