Protocol summary
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Study aim
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The objective of this study is to assess the synergistic effects of majoon-e-suranjaan with and without isometric exercises in rheumatoid arthritis patients.
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Design
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Pragmatic, community based, parallel group, single blinded, randomised controlled trial. Total 100 patients will be enrolled. Patients who met our inclusion criteria randomised into two groups. Control group-A and treatment group-B
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Settings and conduct
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At Muhammad Institute of Medical and Allied Sciences Multan after getting approval from institutional ethical committee.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients of all ages, diagnosed RA, of both gender, and patients with swelling in joints and pain. Exclusion criteria: Patients with vascular neoplasia, fibromyalgia, radiculopathy, neuropathy, tumor, joint fractures, and vestibular problems were excluded.
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Intervention groups
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Control group A will be treated with majoon-e-suranjaan only while treatment group-B will be treated with isometric exercises and majoon-e-suranjaan. Dosage of 5 gm twice a day of majoon-e-suranjaan given after meal in the form of paste taken orally. The isometric exercises given to group B will be upper extremity resistive exercises, resistive hand training with the medicine ball, elbow, and shoulder resistive training by dumbbells. Lower extremity resistive exercises i-e resistive knee training by pressing soft rollers and ankle weights—upper extremity theraband strengthening exercises and lower extremity theraband strengthening exercises.
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Main outcome variables
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Pain, stiffness and physical activities will be main outcome variables. And at the end patient dependency and range of motion will also be assessed. By using WOMAC and NPRS scale, pain stiffness and ADLs were the variables to be assessed. ESR will also be monitored. X-ray will also be done for the assessment of the joints with RA.
General information
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Reason for update
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please update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230202057310N5
Registration date:
2023-09-13, 1402/06/22
Registration timing:
registered_while_recruiting
Last update:
2024-05-30, 1403/03/10
Update count:
2
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Registration date
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2023-09-13, 1402/06/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-04-30, 1402/02/10
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Expected recruitment end date
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2023-10-03, 1402/07/11
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical Trial Analysis of Synergistic Therapeutic Potential of Majoon-e-Suranjaan and Isometric Exercises in Improving Rheumatoid Arthritis
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Public title
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Majoon-e-Suranjaan and Isometric Exercises in Improving Rheumatoid Arthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients of all ages
Diagnosed RA patients
Both genders
patients with swelling in joints and pain.
Exclusion criteria:
Patients with vascular neoplasia
Fibromyalgia
Radiculopathy
Neuropathy
Tumor
Joint fractures
Vestibular problems
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Age
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From 25 years old to 65 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization of participants in groups by lottery method
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Single blinded study. Statistical analyser will be kept blind so that the result obtained will be without biasness.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-05-01, 1402/02/11
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Ethics committee reference number
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MIMAS/0510/IAK Durrani
Health conditions studied
1
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Description of health condition studied
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Rheumatoid Arthritis
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ICD-10 code
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M05
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ICD-10 code description
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Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
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Description
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Pain
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Timepoint
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24 weeks
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Method of measurement
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WOMAC and NPRS scale+ Radiographical findings
2
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Description
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Stiffness
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Timepoint
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24 weeks
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Method of measurement
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WOMAC scale scores
3
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Description
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Daily activities
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Timepoint
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24 weeks
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Method of measurement
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WOMAC scale score
Secondary outcomes
1
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Description
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Increase independency
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Timepoint
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24 weeks
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Method of measurement
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WOMAC scale
2
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Description
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decrease in inflammatory biomarkers
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Timepoint
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24 weeks
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Method of measurement
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Lab investigations
Intervention groups
1
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Description
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Control group: Control group A will be treated with majoon-e-suranjaan Dosage of 5 gm twice a day of majoon-e-suranjaan after meal in the form of paste taken orally.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Treatment group-B will be treated with isometric exercises and majoon suranjaan. Dosage of 5 gm majoon suranjaan given twice a day after meal in the form of paste taken orally. The isometric exercises given to group B will be upper extremity resistive exercises, resistive hand training with the medicine ball, elbow, and shoulder resistive training by dumbbells. Lower extremity resistive exercises i-e resistive knee training by pressing soft rollers and ankle weights—upper extremity theraband strengthening exercises and lower extremity theraband strengthening exercises.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Student fund
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Grant code / Reference number
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MNSUAM/26/05/Mudassir
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Muhammad Nawaz Sharif University of Agriculture
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Proportion provided by this source
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70
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available