Comparing the effect of topical Wishca, Diclofenac and Capsaicin in therapeutic symptoms, outcomes and knee function in different grades of knee Osteoarthritis
Design
Randomized controlled trial; parallel groups, 45 patients
patients were allocated to three treatment groups by simple randomisation using Random numbers table
Settings and conduct
A data review checklist was completed by patient's demographic data and clinical findings (including knee crepitation, effusion, range of motion (ROM) and ligament stability)
Patients were asked to apply 1 mL of ointment 3 times a day, topically on the osteoarthritic knee. At the baseline, the end of week 1 and 4, with one week run in period before beginning the assessment we used the KOOS questionnaire (Knee injury and Osteoarthritis Outcome Score) and VAS to collect patient-reported knee symptoms and function.
outcomes in treatment groups and different OA grades were compared eventually
knee osteoarthritis grading according to Kellgren and Lawrence (K & L) radiologic system
Participants/Inclusion and exclusion criteria
patient with primary knee osteoarthritis,
without any history of knee injury, recent arthroscopy, Intra-articular injection, malignancy acute psychological illness
Intervention groups
Group 1: patient receiving WishCa herbal cream produced in IMD Company (Dr. Kamkar International Laboratory) contains the active ingredient of 7 herbs; - Group 2: patent receiving capex 0.034%, produced by Barijessence inc.
- Group 3: patent receiving Diclofenac Diethylammonium Salt Eq To diclofenac 1% gel produced by RAZAK Labs. Co.
Main outcome variables
symptoms and knee function (KOOS);
pain (VAS);
range of motion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130228012654N2
Registration date:2020-06-02, 1399/03/13
Registration timing:retrospective
Last update:2020-06-02, 1399/03/13
Update count:0
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
Fatemeh Hosseinnezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 2225 0042
Email address
hosseinnezhad.fatemeh70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-03-06, 1396/12/15
Trial completion date
2018-03-06, 1396/12/15
Scientific title
Comparison the therapeutic effect of topical Wishca,Diclofenac and Capsaicin in patient with knee Osteoarthritis
Public title
Comparing the effect of topical Wishca, Diclofenac and Capsaicin cream in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
confirmed knee osteoarthritis according to American Rheumatology Association criteria
history of knee pain
ages 30 to 70
knee pain on most days of >40 mm on a 100 mm VAS on the worst knee
giving informed consent
Exclusion criteria:
patient with other forms of arthritis (including secondary osteoarthritis, Rheumatic diseases
a significant knee injury
Having Low Back Pain and other referral pain to the knee
History of arthroscopy in the previous 6 months,
History of corticosteroid injection in the last 3 months
History of knee surgery
History of the knee clinical trials participation
History of intra-articular injection of hyaluronic acid in the previoHistory of malignancyus 6 months
open knee wound
active dermatitis
Infectious disease involving joints like TB or brucellosis
acute psychological illness (especially depression)
History of malignant neoplasm
history of lower limb trauma leads to rupture of the meniscus, ligament, or capsule
Patients with increased complaints and who are not satisfied with continuing medication
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomztion, a random sequence generated for three treatment groups.
for this purpose, a point in random numbers table was selected and moving to the right, considering single digits, from numbers 1 to 3 assigned to group A: Wishca, numbers 4 to 6 to group B: Cepx and numbers 7 to 9 were assigned to group C: Diclofenac. Based on this sequence, participants entered three treatment groups.
randomization unit: individual
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad Islamic Azad University, Faculty of Medicine
Street address
Sarab street, Shahinfar faculty of medical science
City
Mashhad
Province
Razavi Khorasan
Postal code
9133736351
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.IAU.MSHD.REC.1396.19
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
symptoms and function of affected knee
Timepoint
At the baseline, the end of week 1 and 4 with one week washout period
Method of measurement
KOOS questionnaire
2
Description
pain
Timepoint
At the baseline, the end of week 1 and 4 with one week washout period
Method of measurement
VAS visual analogue scale
3
Description
range of motion
Timepoint
At the baseline, the end of week 1 and 4 with one week washout period
Method of measurement
Angle measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Wishca, patients receiving WishCa herbal cream produced in IMD Company (Dr. Kamkar International Laboratory) contains the active ingredient of 7 herbs; Patients were asked to apply 1 mL of ointment 3 times a day, topically on the osteoarthritic knee.
Category
Treatment - Drugs
2
Description
Intervention group 2: Capsaicin, patients receiving Capex 0.034%, produced by Barijessence inc ; Patients were asked to apply 1 mL of ointment 3 times a day, topically on the osteoarthritic knee.
Category
Treatment - Drugs
3
Description
Control group: Diclofenac patents receiving Diclofenac Diethylammonium Salt Eq To diclofenac 1% gel produced by RAZAK Labs. Co ; Patients were asked to apply 1 mL of ointment 3 times a day, topically on the osteoarthritic knee.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
outpatient Knee & Orthopedic clinic of Imam Reza Hospital of Mashhad
Full name of responsible person
Fatemeh Hosseinnezhad
Street address
Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
7134814734
Phone
+98 51 3713 2127
Email
hosseinnezhad.fatemeh70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Saeed Abtahi
Street address
Sarab street, Shahifar faculty of medicine
City
mashhad
Province
Razavi Khorasan
Postal code
9133736351
Phone
+98 51 3223 5175
Email
Abtahi@mshdiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor of Research, Faculty of Medicine, Mashhad Islamic Azad University
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Hosseinnezhad
Position
medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
00
City
Mashhad
Province
Razavi Khorasan
Postal code
9183857838
Phone
00
Fax
Email
hosseinnezhad.fatemeh70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Hosseinnezhad
Position
medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
sarab street, Faculty of Medicine, Mashhad Islamic Azad University
City
Mashhad
Province
Razavi Khorasan
Postal code
9183857838
Phone
00
Fax
Email
hosseinnezhad.fatemeh70@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Hosseinnezhad
Position
medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sarab Street, Faculty of Medicine, Mashhad Islamic Azad University
City
Mashhad
Province
Razavi Khorasan
Postal code
9183857838
Phone
00
Fax
Email
hosseinnezhad.fatemeh70@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD