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Clinical Trials/SLCTR/2017/039
SLCTR/2017/039
Not Yet Recruiting
N/A

A Randomized Controlled Trial to compare the efficacy of topical Ayurvedic oil preparation against placebo in symptomatic knee osteoarthritis

niversity Grants Commission, Sri Lanka0 sitesTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
niversity Grants Commission, Sri Lanka
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversity Grants Commission, Sri Lanka

Eligibility Criteria

Inclusion Criteria

  • 1\. Diagnosis of symptomatic knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) radiological and clinical criteria, with a functional scale between i – iii.
  • 2\. Radiographic evidence of knee osteoarthritis (osteophytes, joint space narrowing)
  • 3\. Knee pain (3\-4 pain flares per month) along with three out of the following six
  • a. Age \>50 years and \<70 years
  • b. Joint stiffness lasting for less than 30 minutes
  • c. Joint crepitus
  • d. Bony tenderness
  • e. Bony enlargement
  • f. No palpable warmth
  • 4\. Ability to identify a predominantly painful (index) knee with moderate pain in the index knee, defined by pain on walking on a flat surface, pain at rest and climbing upstairs rated as 4 or 5 for questions of the the Western Ontario and McMaster Universities Arthritis Index \[WOMAC \- 11 point numerical rating scale (NRS), v. 3\.1] and a total average WOMAC pain sub scale score of \<7 at the first (B1\) and second (B2\) baseline visits five days apart.

Exclusion Criteria

  • 1\. Inflammatory diseases
  • 2\. History of total knee replacement
  • 3\. Long term use of non\-steroidal anti\-inflammatory drugs (Patients will be required to withdraw from topical non\-steroidal anti\-inflammatory drugs for 48 hours prior to recruitment)
  • 4\. Serious co\-morbidities (e.g. any form of debility that restricts independent movement, stroke, chronic renal failure and inadequate mental capacity to participate in the study)
  • 5\. Difference in pain rating (determined from questions of WOMAC) or the difference in the total average pain score between the B1 and B2 over 2\.
  • 6\. Skin lesions or dermatological diseases in the treatment area
  • 7\. Symptomatic ipsilateral hip osteoarthritis or predominant patello\-femoral knee osteoarthritis
  • 8\. Non\-index knee pain, or any other pain condition requiring the chronic use of pain medication
  • 9\. Intra\-articular injections of hyaluronic acid within 3 months before or during the study
  • 10\. Use of oral, inhaled, parenteral corticosteroids within 2 months before or during the study

Outcomes

Primary Outcomes

Not specified

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