Efficacy of semi-solid form of extract of chamomile, Thymus vulgaris L and Oliveria decumbens to relieve osteoarthritis pain in patients with osteoarthritis.
The effect of cream and gel prepared from the extract of Thyme, Chamomile and Oliveria decumbens on osteoarthritis pain relief.
Design
Phase 3 clinical trial, consisting of two drug-using groups (cream and gel) and one placebo-treated group, with parallel groups, one-blind, randomized block design with a sample size of 100, one-step sampling, non-probability and easy.
Settings and conduct
The study is performed in a rheumatologist's office and under the supervision of a physician. Upon presentation, the patient is given a questionnaire that should be administered for 3 weeks and filled in each week. The physician and the patient are completely blind and only the researcher is aware of the medication the patient is giving.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with osteoarthritis have stage 1 and 2 disease.
Patient satisfaction to participate in the study.
Exclusion criteria:Other underlying diseases that interfere with the study of the effect of the drug.
Pregnant women and lactating women.
Addicts (natural opiates, synthetics or alcohol).
Intervention groups
This study consists of 3 groups. The first group used the cream and the second group as the control group and the third group as the placebo control group to evaluate the effect of the drug on osteoarthritis pain. After the patient is selected by the physician and explained to them, we proceed to distribute the drug.
Main outcome variables
Pain severity; Weakness in daily life function; Knee stiffness.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130722014106N7
Registration date:2019-12-24, 1398/10/03
Registration timing:registered_while_recruiting
Last update:2019-12-24, 1398/10/03
Update count:0
Registration date
2019-12-24, 1398/10/03
Registrant information
Name
Reza Tahvilian
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6482
Email address
rtahvilian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-01, 1398/09/10
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of semi-solid form of extract of chamomile, Thymus vulgaris L and Oliveria decumbens to relieve osteoarthritis pain in patients with osteoarthritis.
Public title
Effect of semi-solid form ofextract of chamomile, Thymus vulgaris L and Oliveria decumbens on osteoarthritis pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with osteoarthritis have stage 1 and 2 disease..
Patient satisfaction to participate in the study.
Exclusion criteria:
Other underlying diseases that interfere with the study of the effect of the drug.
Pregnant women and lactating women.
Addicts (natural opiates, synthetics or alcohol).
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be determined online using the sealedenvelope.com site, blocks and allocation modes. This is based on a sample size of 102 patients with 3 treatment groups (group I cream (A), group II gel (B) and group III, placebo (C)), the blocks are considered to be 6 (6 persons per block), with a total of 17 blocks of 6 persons. For example a few blocks below. Patients in this study would not be aware of medication or placebo.
Block 1: BACABC
Block 2: AABCCB
Block 3: CCABAB
And ...
Blinding (investigator's opinion)
Single blinded
Blinding description
To blind the study, the drugs and placebo were designed to be exactly similar in color, odor and concentration, and the physician and the patient could not discern whether patients were taking the drug or the placebo; And only the researcher and the data collector are aware that the patient has used the drug or the placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Research in Kermanshah University of Medical Sciences
Street address
School of Pharmacy, Nursing Blvd., University Ave., Shahid Shiroudi Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Approval date
2019-09-17, 1398/06/26
Ethics committee reference number
IR.KUMS.REC.1398.682
Health conditions studied
1
Description of health condition studied
Osteoarthritis Pains
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Evaluation of the effect of medication on osteoarthritis pain by the score of completing a questionnaire delivered to the patient.
Timepoint
Symptoms of pain relief are at 7, 14 and 21 days after starting medication.
Method of measurement
How to measure the efficacy of the drug is determined by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire completed by the patient.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group I : This group of patients with osteoarthritis pain, uses cream containing 15% of 3 plant extracts blend in cream base. The patient should use the cream 3 times a day for 3 weeks and complete the questionnaire each week.
Category
Treatment - Drugs
2
Description
Intervention group II: This group of patients with osteoarthritis pain, uses gel. Includes: 3 Plant Extracts Blend 15% in gel base. The patient should take the drug 3 times a day for 3 weeks and complete the questionnaire each week.
Category
Treatment - Drugs
3
Description
Control group: This group of patients with osteoarthritis pain, uses placebo cream and gel, which contains all the ingredients of cream and gel, except for the mixture of 3 plant extracts blend. The patient should take the drug 3 times a day for 3 weeks and complete the questionnaire each week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdie Clinic
Full name of responsible person
Dr.Mehran Pour Nazari
Street address
Mahdie Clinic, opposite Shirin Park, Javanshir Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3727 7700
Email
rtahvilian@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice chancellor for research and technology, Building 2, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Tahvilian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nursing Blvd., University Ave., Shahid Shiroudi Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6489
Email
rtahvilian@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Tahvilian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nursing Blvd., University Ave., Shahid Shiroudi Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6489
Email
rtahvilian@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Tahvilian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Nursing Blvd., University Ave., Shahid Shiroudi Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6489
Email
rtahvilian@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared in the form of scores from patient completed questionnaires.
When the data will become available and for how long
6 months after printing the results.
To whom data/document is available
Researchers working in academic institutions.
Under which criteria data/document could be used
They are only allowed to study the data and use it as a source.
From where data/document is obtainable
Kermanshah University of Medical Sciences
Sayyed Milad Mousavi Mehr miladmosavi8977@gmail.com
What processes are involved for a request to access data/document
Once they have sent the email and registered the request, they will be sent.