A clinical trial to evaluate the efficacy of Ayurvedic treatment protocol in lumbar disc herniation with radiculopathy

Phase 3

Recruiting

• Conditions: Lumbosacral root disorders, not elsewhere classified. Ayurveda Condition: GRUDHRASI,

• Registration Number: CTRI/2023/05/052859
• Lead Sponsor: CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES Ministry of AYUSH, Government of India

Brief Summary

The study is planned as Randomised Controlled trial to evaluate the efficacy of Ayurveda treatment protocol in Lumbar disc herniation with Radiculopathy. The protocol of the study was submitted to CCRAS and Institutional Ethics Committee and got approved. The primary objective of the study is the Clinical evaluation of Ayurveda treatment protocol compared to standard care in lumbar disc herniation with radiculopathy on pain and functional disability and the secondary objectives of the study are to evaluate the change in the quality of life of subjects with lumbar disc herniation with radiculopathy, compare the need of analgesic medication and the clinical evaluation of the safety of Ayurveda treatment protocol compared to standard care in lumbar disc herniation with radiculopathy. Participants will be selected from OPD of National ayurveda Research Institute for Panchakarma, Cheruthuruthy. All the patients with features of lumbar radiculopathy will be screened based on inclusion and exclusion criteria. Those subjects having ODI score between 21% to 60 % will be subjected to MRI lumbosacral spine for confirmation of the diagnosis. Blood investigations like complete hemogram, LFT, RFT, CRP will be performed at screening and after study period. Blood investigations like HbA1C, RBS, RA Factor and HLAB27 will be performed only at screening to rule out any inflammatory pathology. The Sample of size of the study is 80. The selected subjects will be randomized into groups A and B, using the random number table technique. The intervention for group A will be with Ayurveda treatment protocol and group B will be with standard care. The baseline assessment of all the selected participants will be performed and they will be admitted to IPD, National ayurveda Research Institute for Panchakarma, Cheruthuruthy. The clinical assessment will be done on base line, after completion of the IPD treatment, and during follow-ups (30th day and 60 th day). The intervention period of the study is 2 months. Primary outcome measure of the study is Numeric pain assessment scale- VAS scale, Oswestry Disability Index Version 2.0 (ODI) and secondary outcome measure is Assessment of QOL using - Short form 36(SF-36).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-05-18
• Study Start: 2023-07-09

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1.Participants of any gender in the age group 25-55 years.
• 2.Subjects having Oswestry disability index (ODI) score between 21% -60 %.
• 3.Participants diagnosed with lumbar disc herniation with radiculopathy with unilateral radiating pain (either left or right lower limb) due to Intervertebral disc herniation confirmed by MRI (disc herniation between L3 and S1 level; at single or double level) provided no neurologic deficit is evident 4.Positive straight leg raise test (ipsilateral or contralateral pain in the leg, buttock, or back at 70 degrees or less of leg elevation, and the pain is typically worsened by dorsiflexion of ankle or neck flexion after slowly lowering the leg until the patient no longer feels pain 5.Willingness to provide informed consent and adhere to the study protocol for 2 months.

Exclusion Criteria

• 1.Indication for surgical intervention for disc herniation like severe motor deficit (motor power of lower limbs assessed through Medical Research Council Manual Muscle Testing scale ≤3), severe spinal stenosis; excruciating pain that cannot be managed by conservative treatment, foraminal stenosis, conjoint nerve root, perineural cyst etc. 2.Patients who have received non pharmacological interventions like physiotherapy, traction, manual therapy, etc. for the management of lumbar disc herniation in last 3 months. 3.History of or evidence of any of the following.
• Osteoporotic lumbar fracture, presence of inflammatory or infective diseases that affect spinal morphology, such as ankylosing spondylitis, Spondylodiscitis or inflammatory spondylitis, spondylolisthesis, Pott’s spine, Pyriformis syndrome, sacro-iliitis, neural foraminal stenosis 4. History of spinal surgery in last 2 years or having epidural fibrosis. 5.Patients with caudaequina syndrome or neurological deficits such as foot drop, limb muscle wasting and bowel/bladder incontinence or Non-ambulatory patients with Monoplegia/ Paraplegia/ Hemiplegia. 6.Evidence or history of spinal trauma or Spinal Malignancy. 7.Presence of other medical condition presenting with numbness and pain in lower extremities, such as diabetic polyneuropathy and peripheral vascular disease, Motor Neuron Disease, Multiple Sclerosis, Stroke or Cognitive Impairment. 8.Major coexisting medical condition such as cancer, chronic obstructive pulmonary disease, cardiovascular disease and severe hepatic and renal dysfunction. 9.Peptic ulcer disease, GI haemorrhage/perforation. 10.Obesity (BMI greater than or equal to 30 kg/m2). 11.Metallic implants like pace makers, hearing aid implants etc. and other contraindications for MRI. 12.Any other condition that as per the investigator is contraindicated for the intervention in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index Version 2.0 (ODI)	The clinical assessment will be done on base line, after completion of the IPD treatment on 8 th day, and during follow-ups (30 th day and 60th day).

Secondary Outcome Measures

Name	Time	Method
1.Assessment of QOL using - Short form 36 (SF-36)	2.Occurrence of adverse events

Trial Locations

Locations (1)

NATIONAL AYURVEDA RESEARCH INSTITUTE FOR PANCHAKARMA CHERUTHURUTHY; 🇮🇳 Thrissur, KERALA, India

NATIONAL AYURVEDA RESEARCH INSTITUTE FOR PANCHAKARMA CHERUTHURUTHY

🇮🇳Thrissur, KERALA, India

Dr Aswani P S

Principal investigator

9447508751

aswanibalaji2012@gmail.com