1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
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
Protocol summary
Summary
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
2 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
3 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
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
pouladi2008@yahoo.com
4 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) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
empty
