Randomised Controlled Clinical Trial To Evaluate The Efficacy Of Tikta Ksheera Basti And Lashuna Ksheera Basti In The Management Of Gridrasi (Sciatica) And Its Influence On Inflammatory Marker

Study Summary: Randomized Controlled Clinical Trial on Tikta Ksheera Basti and Lashuna Ksheera Basti in the Management of Gridhrasi (Sciatica) and its Influence on Inflammatory Markers

Background: Gridhrasi (Sciatica), a condition characterized by pain radiating from the lower back to the legs, is one of the most common health issues affecting both physical and mental well-being. This study compares two Ayurvedic treatments—Tikta Ksheera Basti and Lashuna Ksheera Basti—both used in managing Vata-related disorders, specifically targeting Gridhrasi. Lashuna (garlic) is known for its anti-inflammatory, antioxidant, and neuroprotective properties, while Tikta Ksheera (medicated milk) is a traditional remedy for Vata disorders. This study seeks to evaluate their effectiveness in alleviating symptoms and their influence on inflammatory markers, particularly C-reactive protein (CRP).

Research Objectives:

1. To evaluate the effectiveness of Lashuna Ksheera Basti in managing Gridhrasi.
2. To assess the influence of Lashuna Ksheera Basti and Tikta Ksheera Basti on inflammatory markers like CRP.
3. To compare the effects of Lashuna Ksheera Basti and Tikta Ksheera Basti in reducing the symptoms of Gridhrasi.
4. To identify a more effective and economical treatment for Gridhrasi.

Research Questions:

1. Is there a significant difference in the effects of Lashuna Ksheera Basti and Tikta Ksheera Basti in managing Gridhrasi?
2. Is there a significant difference in their influence on CRP levels?

Methodology:

• Study Population: 100 patients diagnosed with Gridhrasi (sciatica) will be randomly assigned into two groups of 50 each.
• Group A: Will receive Tikta Ksheera Basti treatment.
• Group B: Will receive Lashuna Ksheera Basti treatment.

Both groups will receive Niruha Basti followed by Anuvasana Basti (oil enema) as per modified Kala Basti Schedule, on the first and last two days of the 9-day treatment regimen both groups will receive only anuvasana basti. CRP levels will be measured before and after treatment.

Inclusion Criteria:

1. Patients aged 20-60 with symptoms of Gridhrasi for less than 1 year.
2. Fit for Basti treatment and willing to provide informed consent.

Exclusion Criteria:

1. Patients with malignant spinal tumors, tuberculosis, uncontrolled diabetes, cardiovascular disease, or pregnancy.

Outcome Measures:

• Primary Outcomes: Improvement in pain (Ruk), pricking sensation (Toda), stiffness (Stambha), heaviness (Gourva), and effectiveness of Basti (Samyak Niruha and Anuvasana Lakshanas).
• Secondary Outcomes: Assessed through clinical signs like Bragard’s sign, the Straight Leg Raising test, and patient-reported measures like walking time, standing time, gait, and Oswestry Low Back Disability Questionnaire.

Laboratory Investigations: CRP will be tested before and after treatment to assess the anti-inflammatory effects.

Duration of Study:

• Treatment: 9 days
• Follow-up: 18 days
• Total: 28 days

Statistical Analysis: Data will be analyzed using SPSS version 21. Parametric and non-parametric tests (t-tests, ANOVA, Mann-Whitney U test, Wilcoxon signed-rank test) will be used to evaluate treatment outcomes, with a significance level set at p < 0.05.

Conclusion: This study aims to determine whether Lashuna Ksheera Basti is more effective and economical compared to Tikta Ksheera Basti in managing Gridhrasi, particularly in reducing inflammation and pain.