A Study On Milaghu Legiyam And Kunthiriga Thailam In The Management Of Vathasthambam

Phase 2

Not yet recruiting

• Conditions: Sciatica,

• Registration Number: CTRI/2023/08/056634
• Lead Sponsor: National Institute of Siddha

Brief Summary

**INTRODUCTION:**

This is an open clinical trial that evaluates therapeutic effectiveness of siddha formulation MILAGHU LEGHIYAM AND KUNTHIRIGA THAILAM in the management of VATHASTHAMBAM (SCIATICA) patients through improvement in The Modified Oswestry Low Back Disability Questionnaire and reduction of pain using the Universal Pain Assesment Scale before and after treatment. Sciatica is a condition characterized by pain affecting the low back, hip and outer side of the leg, caused by compression of a spinal nerve root in the lower back, often owing to degeneration of an inter - vertebral disc. 5%-10% of patients with low back pain have sciatica, whereas the reported lifetime prevalence of low back pain ranges from 49% to 70%. The annual prevalence of disc related sciatica in the general population is estimated at 2.2%.

**OBJECTIVE:**

**PRIMARY OBJECTIVE:**

• To assess the therapeutic effectiveness of MILAGHU LEGHIYAM (INTERNAL) and KUNTHIRIKA THAILAM (EXTERNAL) in the management of VATHASTHAMABAM through The Modified Oswestry Low Back Disability Questionnaire and Universal Pain Assessment Scale before and after treatment.

• To evaluate the standardization of the trial drug Milaghu leghiyam and Kunthiriga thailam

**SECONDARY OBJECTIVE:**

• To evaluate the laboratory parameters before and after the study.

**MATERIALS AND METHODS:**

A Total of 30 diagnosed  patients of Vathasthambam (Sciatica) within the age limit of 20-60 years willing to participate in the study, by signing the consent form will be enrolled in the study. Uncontrolled Diabetes Mellitus, K/H/O Ankylosing spondylitis, K/H/O Vertebral fracture and Spinal deformity, Cardiac diseases and Renal diseases, Pregnant and lactating women and With severe or terminal illness like CA or HIV, Not willing to sign the informed consent will be excluded. Assessment is done through improvement in The Modified Oswestry Low Back Disability Questionnaire and reduction of pain using the Universal Pain Assesment Scale before and after treatment.

**RESULTS AND DISCUSSION:**

The result will be statistically analyzed

**KEYWORDS :**

**Vathasthambam, Sciatica, Milaghu Legiyam**

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-08-16
• Study Start: 2023-08-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Low back pain radiating to lower limb posterolaterally Numbness and paresthesia in same distribution Low back ache aggrevates after prolonged standing and walking Difficulty in bending and lifting Coughing exacerbates the low back pain etc (Any 2 or more symptoms will be included) 2.Positive SLR Test 3.Positive Lasegue Test 4.The Modified Oswestry Disability Scale a score of 40% or more will be taken 5.Patient willing to undergo radiological investigation and laboratory investigation 6.Patient willing to sign the informed consent form.

Exclusion Criteria

1.Uncontrolled Diabetes Mellitus 2.Ankylosis Spondylosis 3.Vertebral fracture and Spinal deformity 4.Cardiac and renal diseases 5.Pregnant and Lactating mother 6.with severe and terminal illness like CA or HIV 7.Not willing to give blood samples for investigation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Reduction in pain is assesed by using the universal Pain Assesment Scale	18 MONTHS
1.Improvement in the Modified Oswestry Low Back Disability Status of the patient before & after the treatment will be obtained	18 MONTHS

Trial Locations

Locations (1)

National Institute of Siddha; 🇮🇳 Kancheepuram, TAMIL NADU, India

National Institute of Siddha

🇮🇳Kancheepuram, TAMIL NADU, India

Dr S Dharshini

Principal investigator

6374290636

dharshiniselvarasu@gmail.com