A clinical study of medicated enema in management of Ankylosing Spondylitis.

Phase 2/3

Not yet recruiting

• Conditions: Ankylosing spondylitis of lumbosacral region. Ayurveda Condition: GAMBIRA-VATARAKTAM,

• Registration Number: CTRI/2022/09/045481
• Lead Sponsor: Shri Krishna Govt Ayurvedic College Hospital

Brief Summary

Ankylosing Spondylitis is characterized by chronic inflammatory arthritis predominantly affecting the sacroiliac joints and spine which can progress to bony fusion of the spine . Chronic back pain and progressive spinal stiffness are the most common features of the disease. Involvement of the spine and sacro-iliac joints, peripheral joints, digits, entheses are characteristics of the disease. Impaired spinal mobility, postural abnormalities, hip pain, peripheral arthritis, enthesitis, and dactylitis are all associated with ankylosing spondylitis. It is present in 1% to 6% of adults inheriting HLA B27, whereas the prevalence is 10% to 30% among HLA B27 positive adults. The onset is typically between the age of 20 to 30 years, with a male preponderance of about 3:1. The global prevalence is less than 0.5% in most populations2.There is no direct correlation of ankylosing spondylitis in ayurveda, However, on the basis of pathogenesis and symptoms ankylosing spondylitis can be correlated to kati-prishtha-trik grah of gambhir vatarakta. Sandhi shoth (jonit inflammation), dhah (joint warmth), stabdhta (joint stiffnes), kathinyata (limited joint movement), abhyantar sandhipeeda (joint tenderness), toda (thrombingpain) in kati (pelvic region), prishtha (posterior region of trunk from neck to pelvis) and trik pradesh (region around shoulder girdle) are the cardinal features of ankylosing spondylitis. In ayurveda, Grah (stiffness) is characteristics feature of vata and kapha dosha. Hence, In the treatment of kati-prishtha-trik grah in gambhir vatarakta (ankylosing spondylitis) primary concern should be effective treatment of kapha and vata dosha, which includes sequential administration of nadi swedan and basti. Basti is the best line of treatment in the management of aggravated vata dosha. Further mustadi aasthapan basti is specially indicated for vatarakta and guduchiyadi aasthapan basti is indicated for vataja vyadhi.

It will be Simple randomized parallel group clinical perspective study with each group 30 patients of Gambhir vatarakta will be selected for study.

The drugs will be prepared in the form of Kwatha for Aasthapana Basti and Murchita Tila Taila for Anuvasana Basti.

Duration of treatment - 16 days

Mode of Administration - Anorectal

Dose - 120 ml

Follow up - Follow up will be done on every 14th, 28th & 42nd day

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-08-27
• Study Start: 2022-10-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients presenting with classical picture of Gambhir vatarakta in katiprishtha-trik grah will be selected irrespective of cast, religion and profession.
• Patients with in the age group of 18 to 60 years.
• Patients who are Basti-Yogya.
• HLA B27 positive.

Exclusion Criteria

• Patients having age below 18 years and more than 60 yrs.
• Low back pain due to fracture of vertebra or traumatic history, Potts spine, tumor of spine, chronic systematic illness, Pregnant and Lactating women.
• Patient who are Contra indicated for Basti.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare efficacy of Mustadi Aasthapan Basti and Guduchiyadi Aasthapan Basti in the management of Kati-Prishtha-Trik Grah in Gambhir Vatrakta w.s.r. Ankylosing Spondylitis.	Duration of treatment - 16 days | Mode of Administration - Anorectal | Dose - 120 ml | Follow up - Follow up will be done on every 14th, 28th & 42nd day | Study will be completed in stipulated time period i.e 1 year

Secondary Outcome Measures

Name	Time	Method
To collect literature of Basti Karma from different text of Ayurveda	To collect literature of Kati-Prishtha-Trik Grah in Gambhir Vatrakta w.s.r. Ankylosing Spondylitis from different text of ayurveda and modern

Trial Locations

Locations (1)

Shri Krishna Govt. Ayurvedic College & Hospital; 🇮🇳 Kurukshetra, HARYANA, India

Shri Krishna Govt. Ayurvedic College & Hospital

🇮🇳Kurukshetra, HARYANA, India

Dr Raja Singla

Principal investigator

9996867471

singla.raja37@gmail.com