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Clinical Trials/CTRI/2025/07/090658
CTRI/2025/07/090658Not yet recruitingNot Applicable

Neurobiological and biochemical assessment of pain perception after Kalari Marma Chikitsa in Sciatica

ITRA, Jamnagar1 site in 1 country30 target enrollmentStarted: July 30, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
The primary outcome is to evaluate the change of leg pain intensity on the basis of VAS from baseline to week 2.

Study Overview

Brief Summary

Kalari Marma Chikitsa is an age old method used in southern regions of India especially the state of Kerala for various neuromuscular and arthrological disorders while clinical studies regarding its efficacy for pain management in sciatica is insufficient. This study aims to explore the feasibility and efficacy of Kalari Marma Chikitsa in pain perception of sciatica patients at both clinical and biochemical levels.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
30.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients suffering from sign and symptoms of sciatica for more than 1month.
  • Patients within the age group 30-65 years, irrespective of gender, religion, occupation, and socioeconomic status will be included in the study.
  • Patients willing to undergo trial.
  • Patients with mild and moderate pain (upto grade 3) on a visual analogue scale.
  • Patients coming under the minimal and moderate disability gradation of Oswestry Low Back Pain Disability Questionnaire.

Exclusion Criteria

  • Patients with red flag conditions in sciatica (muscle wasting of one or both leg, bowel or bladder dysfunction, progressive neurological deficits, saddle anesthesia, sudden onset bilateral radiculopathy, incapacitating pain and unrelenting night pain).
  • Cauda equina syndrome.
  • Fractures related to spine and hip joint.
  • Tuberculosis, other infectious disease and malignancy of lumbosacral spine.
  • Sciatica patients with associated symptoms like fever, nausea, unexplained weight loss and considerable loss of appetite will be excluded.
  • Patients of controlled hypertension.
  • Other diseases like cardiac diseases, renal diseases, endocrine disorders, severe anemia and malignancy.
  • Pregnant or lactating female.

Outcomes

Primary Outcomes

The primary outcome is to evaluate the change of leg pain intensity on the basis of VAS from baseline to week 2.

Time Frame: 0 day and 14 day

To assess the change in pain perception by evaluating the changes in neurotransmitter levels before and after the treatment.

Time Frame: 0 day and 14 day

Secondary Outcomes

  • Changes in paresthesia, stiffness and muscle power grading of muscles of affected lower limb.(Changes in ROM.)

Investigators

Sponsor
ITRA, Jamnagar
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Ipsita Panda

Institute of teaching and research in Ayurveda

Study Sites (1)

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