Evaluation of the effect of edible traditional product” Dawa-e-balgham” on the pain of knee osteoarthritis patients with functional dyspepsia compared to the control group: randomized double-blind clinical trial
Evaluation of the effect of edible traditional product” Dawa-e-balgham” on the pain of knee osteoarthritis (KOA) patients with functional dyspepsia compared to the control group:
Design
This study is clinical Trial with randomized double blind parallel groups of Controlled and study one, and with a sample size of 100.
Settings and conduct
The trial will be conducted in a rheumathology clinic. The patients after inclusion, are divided into two intervention groups ( based on having functional dyspepsia as a strata during randomization). All patients after 2 weeks wash out will be treated with oral medication by random sampling for 8 weeks. Participants, drug deliverers, outcome assessors, and data collectors were blind to the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: knee osteoarthritis diagnos according to American College of Rheumatology (ACR) criteria and signing patient consent form.
Exclusion criteria: significant knee injury or surgery; knee pain related to other joint diseases; severe heart, liver and kidney disease.
Intervention groups
All patients receive oral capsule ( 500 mg) after each meal 3 times a day for 8 weeks. Patients in intervention group take Dawa-Balgham and in control group receive placebo.
Main outcome variables
Pain severity, The quality of patients' performance
General information
Reason for update
Acronym
اوستئوآرتریت زانو Knee osteoarthritis (KOA
IRCT registration information
IRCT registration number:IRCT20190807044470N1
Registration date:2019-11-27, 1398/09/06
Registration timing:prospective
Last update:2019-11-27, 1398/09/06
Update count:0
Registration date
2019-11-27, 1398/09/06
Registrant information
Name
Fariba Hadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3346 0172
Email address
hadiyari1000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-08-31, 1399/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of edible traditional product” Dawa-e-balgham” on the pain of knee osteoarthritis patients with functional dyspepsia compared to the control group: randomized double-blind clinical trial
Public title
Evaluation of the effect of edible traditional product” Dawa-e-balgham” on the pain of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Knee pain at least one for most days of the prior month, in addition to at least 5 of the following 6:
Crepitus on active joint motion
Morning stiffness less than 30 minutes’ duration
Bony enlargement of the knee on examination
Bony tenderness of the knee on examination
No palpable warmth.
Age older than 50 years
Average pain on the Visual Analogue Scale ( VAS ) ≥30 out of 100 mm.
Exclusion criteria:
History of knee surgery
Knee pain related to rheumatological disease or other conditions such as infectious diseases
Pregnancy and breast feeding
Presence of inflammatory rheumatic diseases
Being treated with any of the complementary medicine the prior 3 month
Self management of pain by sedatives and anti inflammatory drugs
Using of corticostereoid less than last 5 weeks ago
Intra-articular depo corticostereoid injection in less than 3 last months.
Intra articular hyaloronate injection in less than past 6 months
Arthroscopy in past one years
history of Significant knee trauma in less than past 6 months
Contraindication for paracetamol using
history of severe cardiac,renal and liver disease
Anticoagulant drugs using
Worrying in heat and dryness
Age
From 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups based on the problem of concurrent dyspepsia as strata after entering the study.Then, randomization is performed for each group using the permuted block randomization method, with patients block size of four. We use https://www.sealedenvelope.com to create a random sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, drug deliverers, clinical caregivers, data collectors and outcome assessors are blind in study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Committee for Ethics in Biomedical Research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-10-06, 1398/07/14
Ethics committee reference number
IR.TUMS.VCR.REC.1398.600
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
2
Description of health condition studied
Functional dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
Primary outcomes
1
Description
Pain severity score on the visual analogue scale
Timepoint
At baseline (before baseline) and 14 days later (at the end of Wash out period) and at week 4, 8, 12, 16 after administration of prophylactic capsules.
Method of measurement
Visual analogue Scale
Secondary outcomes
1
Description
Functional dyspepsia severity score
Timepoint
At baseline (before baseline) and 14 days later (at the end of Wash out period) and at week 4, 8, 12, 16 after administration of prophylactic capsules.
Method of measurement
the Leeds Dyspepsia Questionnaire (LDQ)
2
Description
Quality of life score
Timepoint
At baseline (before baseline) and 14 days later (at the end of Wash out period) and at week 4, 8, 12, 16 after administration of prophylactic
Method of measurement
Knee injury and Osteoarthritis Outcome Score (KOOS)
3
Description
Diagnose of functional dyspepsia score
Timepoint
At baseline (before baseline)
Method of measurement
Rome III questionnaire
Intervention groups
1
Description
Intervention group 1: patients who receive oral capsule ( 500 mg) of Dawa-Balgham containing Nigella sativa L.,Trachyspermum ammi, zataria multiflora and mastic (gum) after each meal 3 times a day for 8 weeks and if needed, acetaminophen tablets can take up to 1 gram every 6 hours.Then patients will be followed for 8 weeks for treatment outcomes. Patients will not be allowed to use acetaminophen during the follow-up period. The duration of the study is 16 weeks.
Category
Treatment - Drugs
2
Description
Control group: the patients who receive placebo containing 125 mili gram toast powder after each meal 3 times a day for 8 weeks and if needed, acetaminophen tablets can take up to 1 gram every 6 hours.Then patients will be followed for 8 weeks for treatment outcomes. Patients will not be allowed to use acetaminophen during the follow-up period. The duration of the study is 16 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Fariba Hadi
Street address
Shariati Hospital, Rheumatology Research Center, North Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8822 0064
Email
hadiyari1000@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad Ali Sahraian
Street address
Sixth Floor,, Qods Ave., Keshavarz Blvd, Central Building of Tehran University of Medical Sciences, Vice Chancellor for Research
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8163 3686
Fax
+98 21 8163 3687
Email
vcr@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fariba Hadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, No. 27, North Supervisor Street, West Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
141663361
Phone
009888974535
Email
hadiyari1000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Nejatbakhsh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, No. 27, North Supervisor Street, West Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
141663361
Phone
+98 21 8897 4535
Email
Nejatbakhsh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Hadi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, No. 27, North Sarparast Street, West Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
1476774431
Phone
+98 21 4443 8632
Email
hadiyari1000@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome of this study will be
shared through the article.
When the data will become available and for how long
The start of the access period will be 6 month after the
results are printed.
To whom data/document is available
Researchers working in academia and academics and
industry professionals
Under which criteria data/document could be used
For further studies in the treatment of knee osteoarthritis based on our study protocol
From where data/document is obtainable
Fariba Hadi: hadiyari1000@gmail.com
What processes are involved for a request to access data/document
Written request by email one month after publication of the article