Home » Trials » SLCTR/2012/009
Study of efficacy between two combinations of herbal medicine (amukkirai chooranam / vellarugu chooranam with thalangai ennai) in the treatment of knee osteoarthritis
-
SLCTR Registration Number
SLCTR/2012/009
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Study of efficacy between two combinations of herbal medicine (amukkirai chooranam / vellarugu chooranam with thalangai ennai) in the treatment of knee osteoarthritis
Public Title of Trial
Study of the combination of amukkirai chooranam with thalangai ennai and vellarugu chooranam with thalangai ennai in the treatment of knee osteoarthritis
Disease or Health Condition(s) Studied
Knee Osteoarthritis
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Which combination of herbal medicine: amukkirai chooranam with thalangai ennai or vellarugu chooranam with thalangai ennai is more efficacious in the treatment of knee osteoarthritis?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
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.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Traditional clinical parameters {Prakriti assessment, eight fold examination and six fold source of knowledge} |
[ At baseline, 10th, 20th, 30th, 40th days, and on follow-up assessment at the end of one month and two months. ] |
|
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. |
[ At baseline, 10th, 20th, 30th, 40th days, and on follow-up assessment at the end of one month and two months. ] |
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. |
[ At baseline and immediately after end of therapy (40th day) then follow-up period at the end of one month and two months. ] |
|
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 |
[ At baseline and immediately after end of therapy (40th day) then follow-up period at the end of one month and two months. ] |
Target number/sample size
300
Countries of recruitment
Sri Lanka
Anticipated start date
2012-09-18
Anticipated end date
2015-01-01
Date of first enrollment
2013-02-21
Date of study completion
Recruitment status
Recruiting
Funding source
Scholarship award for M’Phil / PhD, Higher Education for the Twenty first Century (HETC) Project, Ministry of Higher Education, Sri Lanka
Regulatory approvals
Status
Approved
Date of Approval
2012-07-12
Approval number
J/ERC/12/29//DR/0007
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Jaffna |
| Institutional Address: | ERC Office, Faculty of Medicine, University of Jaffna, Adiyapatham Road, Kokuvil, Jaffna Sri Lanka |
| Telephone: | +94-212222073 (Extension: 342) |
| Email: | ercmedjfn@gmail.com |
Primary study sponsor/organization
HETC Project, Ministry of Higher Education, Sri Lanka.
23/135 Diyawanna Gardens, Chandra Silva MW, Nugegoda
0094 11 2814283, 0094 11 2814279
hrd@hetc.lk
www.hetc.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
