Main objective: To determine the effect of Jujube and Frankincense as complementary on knee osteoarthritis pain relief in selected clinics in 2020-2021.
Design
This is a randomized controlled trial (RCT) with parallel design. This RCT is in phase 1-2. Sample size is 30 participants in each group. The participants will be allocated to intervention and control groups using block random assignment by blocks of four.
Settings and conduct
The setting of this study is outpatient rheumatology clinics. After getting written informed consent they assign to the groups of intervention. In the first stage the severity of pain and limitations will be assessed by VAS and WOMAC, then intervention group will receive Jujube and Frankincense for one week. At the end of first week two questionnaire will be filled again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged 50 to 70.
At least 4 months' history of knee pain.
Informed consent for entrance to the study.
VAS score less than 4.
ESR less than 20.
CRP less than 10.
Exclusion criteria: History of Corticosteroid in last 3 months.
Hyaluronic acid injection in the knee in last 6 months.
Intervention groups
Intervention group receives Jujube and Frankincense as complementary to routine treatment. Control group receives only routine drugs.
Main outcome variables
Pain severity based on VAS and WOMAC questionnaires score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150411021697N2
Registration date:2022-12-04, 1401/09/13
Registration timing:retrospective
Last update:2022-12-04, 1401/09/13
Update count:0
Registration date
2022-12-04, 1401/09/13
Registrant information
Name
Mohammad-Reza Sohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9936
Email address
m.sohrabi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-01, 1400/09/10
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Jujube and Frankincense as complementary on knee osteoarthritis pain relief
Public title
Effect of Jujube and Frankincense on knee osteoarthritis pain relief
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 50 to 70 years.
Knee pain for the past 4 months.
VAS score less than 4.
CRP less than 10.
ESR less than 20.
Informed consent for entrance to the study.
Exclusion criteria:
History of disorders in heart, liver and kidney.
Corticosteroid consumption in last 3 months.
Hyaluronic acid injection in last 6 months.
History of inflammatory diseases in joints.
Pregnancy
Breast feeding
Age
From 50 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the participants will be assigned into two intervention and control groups by random block allocation method with a ratio of 1:1. Blocks of sizes 4 and 6 will be made with different sequences of A and B. They will be lined up in a random series. Finally, the order of the letters A and B will determine the sequence of entering the participants in the two groups. A and B cards will be placed in sealed envelopes with consecutive numbers from 1 to 60. As each participant enters, the envelope corresponding to the participant's number is opened, and their treatment group is determined. Sealedenvelope.com will be used to build the above random chain.
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 Shahid Beheshti University of Medical Sciences
Street address
Velenjak. Arabi St.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-10-31, 1400/08/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.475
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
Pain severity
Timepoint
Pain severity will be assessed the first and 7th day.
Method of measurement
VAS and WOMAC tools.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment in intervention group will be prescription of pill of Jujube and Frankincense twice daily as a complimentary to other routine analgesic drugs for 7 days. Each pill contains 250 mg Jujube and 100 mg Frankincense. It is made in school of pharmacy at Shahid Beheshti University of Medical Sciences.
Category
Treatment - Devices
2
Description
Control group: This group receives only the routine analgesic drugs for 7 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool َAkram Hospital
Full name of responsible person
Nahid Kianmehr
Street address
Tehran villa
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
m.r.sohrabi@gmail.com
Web page address
https://hrmc.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mostafa Rezaie Tavirani
Street address
Velenjak, Arabi St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2206
Email
tavirany@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad-Reza Sohrabi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health
Street address
Tabnak Ave. Evin.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9936
Fax
+98 21 2243 9936
Email
m.sohrabi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad-Reza Sohrabi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health
Street address
Tabnak Ave. Evin.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9936
Fax
+98 21 2243 9936
Email
m.sohrabi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad-Reza Sohrabi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health
Street address
Tabnak Ave. Evin.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9936
Fax
+98 21 2243 9936
Email
m.sohrabi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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