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Clinical Trials/CTRI/2019/02/017768
CTRI/2019/02/017768Active, not recruitingPhase 2

An Open Label Randomized Clinical Study to evaluate the efficacy of Patrapinda Swedana and Erandamooladi Basti followed by Shamana with and without Virechana in the management of Kati-Prishtha-Trik Graha with special reference to Ankylosing Spondylitis.

National Institute of Ayurveda1 site in 1 country38 target enrollmentStarted: March 15, 2019Last updated:

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Enrollment
38
Locations
1
Primary Endpoint
Changes in lumbar flexion

Study Overview

Brief Summary

Ankylosing spondylitis(AS) or Marie Strumpell Disease is a chronicinflammation of the spine that primarily involves the sacroiliac joints and theaxial skeleton. The clinical features of AS can be divided inspinal and extra spinal features. The spinal involvement results in complaintsof chronic inflammatory back pain with morning stiffness. This morning stiffnesslasts at least one hour, but often many hours, and improves with exercise butis not relieved by rest. Nocturnal exacerbation of painthat forces the patient to rise and move may be frequent. Pain at the cervicalregion and of the thoracic spine, especially with chest expansion, is caused byinvolvement of the cervical and costovertebral joints. The spinal inflammationcoincides with the formation of syndesmophytes and squaring of the vertebrae,sometimes evolving into the classical bamboo spine, can lead to spinalankylosis with a limited chest expansion, limited neck motion, flattening ofthe lumbar spine and thoracic kyphosis. Thereis no direct correlation of Ankylosing spondylitis mentioned in Ayurveda. Butdue to the maximum proximity of symptoms and pathology, AS in present study isbeing correlated to Kati-Prishtha-Trik-Graha mentioned inclassics. Shoola(Pain), and Graha (Stiffness) in Kati (Pelvis), Prishtha (Posterior region of trunk from neck to pelvis), and Trik pradesha(Region around shoulder girdle) are the cardinal features of AnkylosingSpondylitis. In Ayurved, Graha (Stiffness) is one of the characteristic features ofaggravated Vata and Kapha Dosha. Hence in the treatment of Kati-Prishtha-Trik Graha (Ankolysing Spondylitis), primary concern shouldbe effective treatment of Kapha and Vata Dosha,which includes sequential administration of Swedana,Srotoshodhana and Basti. The present study will be conducted on 38 pre-diagnosed cases of Ankylosing spondylitis or those fulfilling the Spondylo Arthritis International Society(ASAS) criteria for Ankylosing Spondylitis. The patients will be randomly divided into 2 Groups. Patients in Group A will be treated with Patrapinda Swedana, Virechana, Erandamooladi Basti and Shamana therapy, while Patients in Group B will receive the same treatment except Erandamooladi Basti. Assessment will be carried out before and after treatment. Observations will be recorded, compared and will be statistically tested. Final conclusion will be drawn after the statistical analysis of the observations.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Open Label

Eligibility Criteria

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

Inclusion Criteria

  • Patients fulfilling the Assessment of Spondylo Arthritis International Society (ASAS) criteria for Ankylosing Spondylitis, or pre-diagnosed cases.
  • Patient having symptoms of Kati-Prishtha-Trik Graha, Patient having sign and symptoms of Ankylosing spondylitis, Chronicity: less than 10 yearsPatients indicated for Patrapinda Swedana, Virechana and Basti Karma.

Exclusion Criteria

  • Patients having serious Cardiac, Renal or Hepatic diseases, uncontrolled Hypertension, Diabetes.
  • Pregnant & lactating women.
  • Patients contraindicated for Patrapinda Swedana, Virechana and Basti Karma.

Outcomes

Primary Outcomes

Changes in lumbar flexion

Time Frame: 100 days

Secondary Outcomes

  • Relief in Pain, Stiffness(100 days)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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