Study of the combination of amukkirai chooranam with thalangai ennai and vellarugu chooranam with thalangai ennai in the treatment of knee osteoarthritis

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2012/009
• Date of registration: 17/09/2012
• Primary sponsor: HETC Project, Ministry of Higher Education, Sri Lanka.
• Public title: Study of the combination of amukkirai chooranam with thalangai ennai and vellarugu chooranam with thalangai ennai in the treatment of knee osteoarthritis
• Scientific title: Study of efficacy between two combinations of herbal medicine (amukkirai chooranam / vellarugu chooranam with thalangai ennai) in the treatment of knee osteoarthritis
• Date of first enrolment: 18/9/2012
• Target sample size: 300
• Recruitment status: Select Status
• URL: http://www.slctr.lk/trial_details.asp?reg_id={E7BEF004-6F3D-49AD-AEE2-63B851B2CBF9}
• Study type: Interventional
• Study design: Open labeled, Randomised, parallel group trial

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr. (Miss) Vinotha Sanmugarajah
• Affiliation: Lecturer (Probationary)

• Name: Dr. (Mrs) Sri Ranjani Sivapalan (supervisor)
• Affiliation: Senior Lecturer Gr.I

Key inclusion & exclusion criteria

Inclusion criteria: 1. Subjects suffering from knee osteoarthritis diagnosed based on history, clinical examination findings and classical radiological findings, and fulfilling the American College of Rheumatology (ACR) classification criteria 2. Age above 40 years 3. Pain visual analogue score (VAS) > 4 in one or both the knees while performing a weight bearing activity 4. Ambulant and require analgesic for pain relief and / or not satisfied with ongoing analgesic drugs and seeking a change.
Exclusion criteria: 1. Subjects with non-degenerative joint diseases or other joint diseases such as and#256;ma vand#257;ta (rheumatoid arthritis), Kazhugazha vand#257;ta, (psoriatic arthritis), Piramega vand#257;ta (gonococcal arthritis), Narithalai vand#257;ta (haemo arthritis) 2. Subjects with severe disabling arthritis and / or bedridden. 3. History of intra-articular knee injection within the month preceding the study 3. Severe unstable renal, hepatic, diabetic, haemopoietic, malignant, hypertensive, cardiac disorder and mentally affected as revealed by history and / or investigation. 4. Subject taking antipyretics, analgesics, tranquilizers, hypnotics, alcohol, or any other drug which would interfere with pain perception and need for other drug therapy for arthritis 5. Women who are pregnant, lactating 6. Those unwilling to come for regular follow-up for the entire duration of the study.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Knee osteoarthritis

Intervention(s)

Patients will be recruited for the trial following qualitative and quantitative analysis of the trial medicines (Amukkirai and Vellarugu chooranam) and a pilot study.

Subjects for the clinical trial will be selected from Out Patients Department (O.P.D.) and Indoor Patients Department (I.P.D.) of Ayurvedic Hospitals / Dispensaries in Jaffna District. Eligible patients with knee osteoarthritis will be randomized in a 1:1 ratio to the treatment arms.

The prescribed dose is two capsules thrice a day with lukewarm water after meals. The daily dose of experimental medicine is 3g (Each capsule contains 500mg of trial plant materials) and local applications of oil {10ml} twice a day for one mandalam (40 days). Subjects will be requested to refrain from other alternative medicinal therapy (allopathic, homeopathy, acupuncture, and acupressure, etc.) during the study period.

Primary Outcome(s)

1.Traditional clinical parameters {Prakriti assessment, eight fold examination and six fold source of knowledge}


2.Clinical parameters: gait, knee joint pain {Visual Analogue Scale (VAS)}, stiffness, tenderness on knee joint, knee joint swelling, muscular wasting (a tape measure), local crepitation, walking time, restriction of knee joint movement, range of knee joint movements (Goniometer assessment), knee joint deformities and muscular power.

Secondary Outcome(s)

1. The effect of morbidity status on health related quality of life in subjects will be measured by the WOMAC questionnaire, goniomter assessment and Visual analogue Scale. Questionnaire will be used to assess pain, stiffness and physical functions depending on score basis. Movements and pain will be measured by goniometer and VAS scale respectively.


2. Routine laboratory workup (haemoglobin, White blood cell - total and differential count, Erythrocyte sedimentation rate, Rheumatoid factor assays, Liver function test and Kidney function test} and X-rays of knees

Secondary ID(s)

None

Source(s) of Monetary Support

Scholarship award for M’Phil / PhD, Higher Education for the Twenty first Century (HETC) Project, Ministry of Higher Education, Sri Lanka