Clinical Evaluation of Combined Effectiveness of Vatari Guggulu and Pippalyadi Taila Matra Basti in Management of Gridhrasi (Sciatica)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Ruk (pain)
Study Overview
Brief Summary
Current clinical study is clinical evaluation of combinedeffectectiveness of vatari guggulu and pippalyadi taila matra bastiin the management of gridrasi (Sciatica).In the present study, anopen label single arm clinical trial at IPD basis will be done withpre and post-test design for the included 30 patients.Here vatariguggulu 500 mg thrice daily in the morning and night will beadministered after food with ushnodaka as anupana for the first 8days.Along with this pippalyadi thaila anuvasana basti 70 ml will begiving once in a day for 8 days The patient will be discharged withvatari guggulu for the next 16 days..Hence the entire treatment willbe completed in 16 days.
The patient willbe assessed on the 1st day 8th day and 16thday. Assessment would be done based on subjective and objectiveparameters and would also be monitored for Adverse Drug Reactions orAdverse Drug Effects or other concurrent illness.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 25.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •(a) DIAGNOSTIC CRITERIA Patients with features of Gridhrasi (sciatica) like
- •Ruk on SphikPoorva, Kati, Prishta, Uru, Janu, Jangha and Pada Paryanta (Pain radiates from low back to the leg/s)
- •Toda (Pricking sensation)
- •Stambha (Stiffness)
- •Spandana (Fasciculation)
- •Positive Straight Leg Raising test
- •Positive Breggard’s sign
- •Laseague’s sign
- •Bowstring sign
- •Tenderness of nerves
- •Unilateral leg pain extending below the knee (with or without strength,sensory or reflex changes) and a positive straight leg raising sign
- •Those who are fit for Basti treatment
- •Patients of intervertebral disc prolapsed,lumbar spondylosis,lumbo sacral strain
- •Those patients who are ready to sign informed consent form.
Exclusion Criteria
- •Neoplastic and infective conditions of the spine
- •Uncontrolled Diabetes mellitus, Uncontrolled Hypertension, Neurological complications
- •Fractures of pelvis and femur 5.
Outcomes
Primary Outcomes
Ruk (pain)
Time Frame: 16 days
Subjective parameters:
Time Frame: 16 days
Stambha (stiffness)
Time Frame: 16 days
Gauravata(Heaviness)
Time Frame: 16 days
Toda (pricking sensation)
Time Frame: 16 days
Gait
Time Frame: 16 days
Objective Parameters:
Time Frame: 16 days
Straight leg raising test
Time Frame: 16 days
Visual analog scale for pain
Time Frame: 16 days
Flip test
Time Frame: 16 days
Laseague’s sign
Time Frame: 16 days
Breggard’s sign
Time Frame: 16 days
X-ray
Time Frame: 16 days
Secondary Outcomes
- Toda (pricking sensation)(Gauravata(Heaviness))