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Clinical Trials/CTRI/2024/09/074159
CTRI/2024/09/074159
Not yet recruiting
Phase 3 4

A Clinical Study To Evaluate The Efficacy Of Vaitraina Basti and Anuvasana Basti With Ashtkatwar Taila(Kala Basti) in the Management Of Gridhrasi Sciatica

Dr Sarvapalli Radhakrishnan Rajasthan Ayurved University Kadwar Jodhpur Rajasthan1 site in 1 country60 target enrollmentStarted: October 10, 2024Last updated:

Overview

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Dr Sarvapalli Radhakrishnan Rajasthan Ayurved University Kadwar Jodhpur Rajasthan
Enrollment
60
Locations
1
Primary Endpoint
The primary outcome of this study is to assess the clinical efficacy of Vaitarana Basti and Ashtkatwar Taila Anuvasana Basti in managing Gridhrasi (Sciatica). It evaluates subjective parameters like pain, stiffness, and pricking pain, along with objective measures such as inflammation markers (ESR, CRP) and imaging tests.

Overview

Brief Summary

This study is single arm, an open label non randomized trial, with single group of 60 patient to assess the effect of vaitrana basti and Anuvasan basti( with Ashtkatwar Taila) in the management of Gridhrasi( Sciatica). The primary objective of present study is reducing subjective parameters like- Pain, Stiffness ,Pricking pain, Pulsation, Numbness and objective parameters like- Digital X-ray, ESR, CRP. Vaitaran basti and Anuvasan basti (with Ashtkatwar Tail) given in the pattern of Kala Basti ( 16 days). In the present study single group is taken.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
30.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients of either sex in the age group of 30 to 60 Years Clinical signs and symptoms of Gridhrasi present in the classical texts Tenderness at the course of Sciatica Nerve Severe pain on squatting Patients willing to give written consent.

Exclusion Criteria

  • Fractured related to spine Patients who are suffering from any systemic disorders Tuberculosis of spine and Hip Joint Malignancy Traumatic Infective Neoplastic conditions of Spine Patients who have lost the control on bladder and defecation Pregnant and lactating women.

Outcomes

Primary Outcomes

The primary outcome of this study is to assess the clinical efficacy of Vaitarana Basti and Ashtkatwar Taila Anuvasana Basti in managing Gridhrasi (Sciatica). It evaluates subjective parameters like pain, stiffness, and pricking pain, along with objective measures such as inflammation markers (ESR, CRP) and imaging tests.

Time Frame: 31 days

Secondary Outcomes

  • The secondary outcome aims to enhance the patients quality of life by improving mobility & overall well-being. Additional benefits & any unexpected effects of the treatments will also be monitored. Statistical tests will validate the significance of the treatment outcomes.(31 days)

Investigators

Sponsor
Dr Sarvapalli Radhakrishnan Rajasthan Ayurved University Kadwar Jodhpur Rajasthan
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Neeraj Kumar Pathak

Post Graduate Institute of Ayurveda Jodhpur Rajasthan

Study Sites (1)

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