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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010574
Enrollment
180
Registered
2017-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: 1. Trayodashanga guggulu (AFI â?? Part 1, API Part II Vol.II)) 2. Maharasanadi kwatha (AFI â?? Part 1) Prasarini Taila (AFI â?? Part 1, API Part II Vol.III) : 1. Trayodashanga guggulu (

Sponsors

Central Council for Research in Ayurvedic Sciences CCRAS
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. Improvement in MRI 2. Coin Test 3. Lumbar spine mobility test (LSM) 4. Femoral Nerve Strech Test (FNS) 5. Change in laboratory parameters and X-Ray Timepoint: 12 weeks

Countries

India

Contacts

Public ContactDr Sulochana Bhat

Regional Ayurveda Research Institute for Metabolic Disorders

nadri.bengaluru1@gmail.com080-26564599

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026