Home » Trials » SLCTR/2017/039


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

SLCTR Registration Number

SLCTR/2017/039


Date of Registration

02 Nov 2017

The date of last modification

Nov 02, 2017



Application Summary


Scientific Title of Trial

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


Public Title of Trial

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


Disease of Health Condition(s) Studied

Knee Osteoarthritis


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1154-7762


Any other number(s) assigned to the trial and issuing authority

EC-13-133 - Ethics Review Committee, faculty of Medicine ,Colombo


Trial Details


What is the research question being addressed?

Is the Ayurvedic oil preparation (Kubja prasaranie) effective when compared to a placebo in reducing pain, stiffness, and improving function in the treatment of symptomatic knee osteoarthritis?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Crossover


Purpose

Treatment


Intervention(s) planned

Study Setting: outpatient clinics of National Ayurveda Hospital, Rajagiriya, Sri Lanka. This study is designed as a double blinded randomized controlled crossover trial.

Targeted study population is patients with symptomatic knee osteoarthritis undergoing acupuncture therapy, attending outpatient clinics of National Ayurveda Hospital, Rajagiriya, Consecutive patients fulfilling selection criteria would be recruited into the study. Study participants would be divided into two groups randomly using computer generated numbers.

Interventional product: The ingredients of our Ayurvedic oil preparation, Kubja prasaranie are as follows. Prasarani (Paederiafoetida), rathnithul (Plumbegoindica), valmi (Glycyhizaglabra), wadakaha (Acrouscalamus),shatapushpa (Anethumsowa), devadara (Cedrusdeodara), aratta (Alpinia calcarata), gajatippli (Scindapsus officinalis), Jatamansha (Nardostahys jatamansi) bhallathska (Semecarpus anacardium).The base of the oil is made with sesame oil, cow milk, kaadi (vinegar).The Ayurvedic oil is prepared according to standard Ayurvedic texts.

Two randomized groups will receive a placebo oil (prepared from virgin coconut oil) or the medicinal oil preparation for a period of 4 weeks. After a washout period of 4 weeks, the same subjects will crossover to receive the other compound. In keeping with current Ayurvedic practices both groups of patients will be instructed to apply the Ayurvedic oil and the placebo oil separately to the intact skin on both side of the knee and the popliteal fossa, but to avoid the patella. They will be requested to apply the oil 10 ml at time, twice a day for a total of 4 weeks. The oil should be left for a minimum of one hour after application.

All other management will be provided equally to both arms according to standard protocols at the institute. Participants, health care workers, data collectors and data analysts will be blinded to the intervention status.


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
  11. Intra-articular injections of corticosteroids within one month from the study


Primary outcome(s)

  1. Reduction of pain
  2. Reduction of functional limitation
  3. Reduction in stiffness

The outcomes will be assessed using the Western Ontario and McMaster Universities (WOMAC) composite index.


Primary outcome(s) - Time of assessment(s)

At baseline, at the end of the 2nd week and 4th week, at the beginning of 8th week, at the end of the 10th week and 12th week after commencement of the intervention.


Secondary outcome

None


Secondary outcome(s) - Time of assessment(s)

None



Target number/sample size

320 (160 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2017-12-12


Anticipated end date

2018-06-01


Recruitment status

Pending


State of ethics review approval

• Approved from Ethics Review Committee, Faculty of Medicine, University of Colombo on 19th December 2013 • Ref. No. : Ec-13-133 • Extension Date :18th April 2017


Funding source

University Grants Commission, Sri Lanka (Grant no. UGC/VC/DRIC/IRG-2014/CMB)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Inoshi Atukorala
Senior Lecturer in Clinical Medicine & Consultant Rheumatologist
University Medical Unit, National Hospital Sri Lanka & Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Sri Lanka
Tel: 0112695300 (Ext 134)
Mob: 0773 950 048
Fax: (+94 11) 2689188
inoshi.atu@gmail.com

Contact Person for Public Queries

Dr. Inoshi Atukorala
Senior Lecturer in Clinical Medicine & Consultant Rheumatologist
University Medical Unit, National Hospital Sri Lanka & Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Sri Lanka
Tel: 0112695300 (Ext 134)
Mob: 0773 950 048
Fax: (+94 11) 2689188
inoshi.atu@gmail.com


Primary study sponsor/organization

University Grants Commission, Sri Lanka

No. 20, Ward Place, Colombo 07, Sri Lanka
Tel: +94 11 2695301
Fax: +94 11 2688045
chairman@ugc.ac.lk
http://www.ugc.ac.lk/

Secondary study sponsor (If any)

None