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Study to compare the Efficacy of Siravedha versus Distal Sodium Channel Block in the Management of Sciatca (Grudrasi)

Phase 2/3
Not yet recruiting
Conditions
Sciatica,
Registration Number
CTRI/2025/04/085001
Lead Sponsor
National Institute of Ayurveda
Brief Summary

In Ayurveda *Grudhrasi* is a type of *Vatvyadhi* characterized by the clinical features of radiating pain from *Spikha* (gluteal region) to *Pada* (foot). *Vata* and *Kapha* are predominantly involved dosha in this disease and pain is the cardinal symptom.[[i]](file:///C:/Users/panka/Desktop/dr.%20ritu%2031-1-25%20iec%20v2.docx#_edn1) Based on the symptomatology of *Ghrudhrasi* it can be corelated with the disease Sciatica in modern parlance.Sciatica occurs due to spinal nerve irritation and is characterized by pain in distribution of sciatica nerve manifesting into chronic radiating low back pain to lower limbs

Distal Sodium Channel Block (DSCB) is a newer concept of pain management which is now being widely practiced. Infiltration of local anesthetic drugs singly or in combination with those that augment or prolong its action around the nerve sheaths, at the most terminal branch along its course



Primary Objective:

•      To assess & compare the efficacy of *Siravedha* and DSCB in the management of Sciatica.

Secondary Objectives:

•       To assess the outcome of *Siravedha* and DSCB.

•       To assess the patient’s quality of life .(SF-12 Questionnaire)

Patients attending the OPD/IPD of the PG Department of *Shalya Tantra,* NIA hospital will be selected who will be fulfilling the criteria of inclusion, details of the study will be explained, and informed written consent of each patient will be taken on prescribed proforma. After that clinical trial will be executed



Total 40 patients will be selected after detail examination and divided in 2 groups of 20 patients each as per study protocol. All Procedures will be executed done under aseptic condition.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Age: Patients of either gender between 25-60 years.
  • Patient having typical clinical feature pertaining to the Sciatica like Constant aching pain felt in the lumbar region and may radiate to the buttock, thigh, calf and foot.
  • Diagnosed case of Sciatica through Positive Passive SLRT and Buckling test .
  • Patients having normal CT, BT and Hb above 10gm percent will undergo Siravedha Patient willing to undergo trial.
Exclusion Criteria
  • •Patients with infectious diseases of spine.
  • •Patient with infection at the site of DSCB infiltration and Siravedha.
  • •Patients with past history of or ongoing malignancy or chemotherapy or radiotherapy •Patients with uncontrolled Diabetes mellitus, Cardiovascular diseases, HIV,Hypertension •Pregnant or Lactating Females.
  • •Patients with known hypersensitivity.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
•Change in VAS, MRSS Score , SLR &Buckling test.BASELINE And 57 Days
•Improvement in symptoms of Sciatica.BASELINE And 57 Days
Secondary Outcome Measures
NameTimeMethod
Change in the quality of life of the patient.( as per SF-12 Questionnaire).BASELINE And 57 Days

Trial Locations

Locations (1)

National Institute Of Ayurveda

🇮🇳

Jaipur, RAJASTHAN, India

National Institute Of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
Ritu Thakur
Principal investigator
07006133129
19ritu23@gmail.com

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