Comparison of herbal composition colchicum autumnale, saffon and ginger with celecoxib on clinical symptoms in aged 60-70 years with osteoarthritis of the knee in Bushehr
The aim of this study is comparison of herbal composition colchicum autumnale, saffon and ginger with celecoxib on clinical symptoms in aged 60-70 years with osteoarthritis of the knee in Bushehr.
Inclusion criteria included getting older, based on clinical signs of osteoarthritis of the knee based on the doctor, the symptoms for more than 6 months, no getting treated with pain medication, no history of gastrointestinal bleeding, and exclusion criteria included non-routine monitoring of the patient's medications, other analgesic consumption during the period.
The study population is elderly patients with osteoarthritis of the knee 60 to 70, and the sample size is 160 people.
The intervention involves the use of an herbal combination (herbal composition colchicum autumnale, saffon and ginger ) and celecoxib (100 mg) over a period of two months to and a washout period of one week and then open a two-month experiment with moving drugs Groups. primary outcome measure will be such as: decrease of knee pain, decrease of knee rigidity and improve of activity daily living.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015053022466N1
Registration date:2015-08-05, 1394/05/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-05, 1394/05/14
Registrant information
Name
Shahnaz Pouladi
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 374 0061
Email address
sh.pooladi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2015-07-01, 1394/04/10
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of herbal composition colchicum autumnale, saffon and ginger with celecoxib on clinical symptoms in aged 60-70 years with osteoarthritis of the knee in Bushehr
Public title
Comparison of herbal composition colchicum autumnale, saffon and ginger with celecoxib on clinical symptoms in aged 60-70 years with osteoarthritis of the knee in Bushehr
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included age located within 60 to 70 years (young adult), getting older, based on clinical signs of osteoarthritis of the knee (Knee pain, stiffness and loss of function of the knee) based on the doctor, the symptoms for more than 6 months,getting treated with pain medication, avoiding the use of drugs (opium, etc.), lack of trauma to the knee, no history of hypersensitivity to NSAIDs or a history of gastrointestinal bleeding, Consent to participate in the study؛ Being mentally alert؛ ability to verbal communication؛ response to questions؛ reform of temperament by physician. exclusion criteria:lack of routine monitoring of patients taking drug؛ other analgesic use during the period؛ the patient's unwillingness to continue to participate؛ trauma to the knee during therapy؛ the patient only.
, and with the ability to track enough to be conscious of the mind and the ability to communicate verbally and modified Vpaskhgvyy questions natured doctor (regimen) are. Exclusion criteria included non-routine monitoring of the patient's medications, other analgesic consumption during the period, the company's unwillingness to continue the patient and trauma to the knee during the treatment period and are just being patient.
Age
From 34 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences, Bushehr Iran
City
Bushehr
Postal code
Approval date
2015-05-18, 1394/02/28
Ethics committee reference number
bpums.rec.1394.4
Health conditions studied
1
Description of health condition studied
Knee osteoartritis
ICD-10 code
M23.4
ICD-10 code description
Loose body in knee
Primary outcomes
1
Description
pain
Timepoint
before and after intervention
Method of measurement
VAS and Koos questionnaire
2
Description
Knee regidity
Timepoint
before and after intervention
Method of measurement
Koss questionnaire
3
Description
activity daily living disfunction
Timepoint
before and after intervention
Method of measurement
Koss questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In group A, before the intervention using a questionnaire and clinical symptoms of knee osteoarthritis in the participants will check .Then initially treat with celecoxib 100 mg twice a day for 2 months . During this period the necessary follow-up regarding the proper use of drugs is carried out by the researcher. After two months, the clinical symptoms of osteoarthritis of the knee re-examined using a questionnaire, followed by a 7-day clearing period there. After the end of a week of clinical symptoms of osteoarthritis of the knee re-examined by questionnaires. Then Herbal Capsules (colchicum autumnale, saffon and ginger) to 500 mg twice a day for two months will be given to participants. After two months, the clinical symptoms of osteoarthritis of the knee re-examined by means of questionnaire.
Category
Treatment - Drugs
2
Description
In group B, before the intervention using a questionnaire and clinical symptoms of knee osteoarthritis in the participants will check .Then initially the group B treat with herbal Capsules (colchicum autumnale, saffon and ginger) to 500 mg with twice a day for 2 months . During this period the necessary follow-up regarding the proper use of drugs is carried out by the researcher. After two months, the clinical symptoms of osteoarthritis of the knee re-examined using a questionnaire, followed by a 7-day clearing period there. After the end of a week of clinical symptoms of osteoarthritis of the knee re-examined by questionnaires. Then capsule celecoxib 100mg twice a day for two months will be given to participants. After two months, the clinical symptoms of osteoarthritis of the knee re-examined by means of questionnaire.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Saheb Zaman Health Clinic
Full name of responsible person
Farideh Salehi, Master Nursing Student
Street address
Bushehr, Bageh Zahra,
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Ostevar
Street address
Bushehr University of Medical Sciences, Research Department
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Shahnaz Pouladi, PhD
Position
Nursing PhD
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Nursing and Midwifery Department
City
Bushehr
Postal code
Phone
+98 77 3455 0187
Fax
Email
pouladi2008@yahoo.com sh.pooladi@bpums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Shahnaz Puladi PhD
Position
Nursing PhD
Other areas of specialty/work
Street address
Bushehr Univeristy of Medical Sciences, nursing and Midwifery Faculty
City
Bushehr
Postal code
Phone
+98 77 3455 0187
Fax
Email
pouladi2008@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Shahnaz Pouladi
Position
PhD/Lecturer
Other areas of specialty/work
Street address
Bushehr Univeristy of Medical Sciences, nursing and Midwifery Faculty
City
Bushehr
Postal code
Phone
+98 77 3455 0187
Fax
+98 77 3455 0187
Email
sh.poolladi@bpums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)