Protocol summary
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Study aim
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The study aim to clinically and biochemically assess the effects of Calotropis gigantea and Curcuma longa with and without Phonophoresis in Osteoarthritis.
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Design
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A pragmatic, community-based study. A single-blinded, randomized controlled trial with a parallel group design of 150 patients, will enroll between August 2023 to September 2023.
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Settings and conduct
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The study will be conducted at Muhammad Physiotherapy and Rehabilitation Center, Multan, Pakistan. After approval obtained from the Iranian Registry of Clinical Trial and institutional ethical committee.
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Participants/Inclusion and exclusion criteria
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According to the Kellgren and Lawrence system of grading, patients with the grade 1-2-3 knee osteoarthritis, age 45-70 years of either gender (male and female) will include in this experiment. Patients with neural defects, total knee replacement, RA, injected with steroidal injections in the past 2 years will exclude in this experiment.
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Intervention groups
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The patients will be engaged after signing the written consent form. The lottery method will be used for grouping of 150 patients into 5 parallel groups (n=30). Group 1 will be treated with test drug with phonophoresis with therapeutic ultrasound (frequency of 0.8MH, and an intensity of about 1.5 W/cm2, and with the continuous mode). Group 2 will be treated with test drug with superficial massage. Group 3 will be treated with standard drug piroxicam 0.5% w/w with phonophoresis. Group 4 will be treated with standard drug with superficial massage. Group 5 will be treated with therapeutic ultrasound using aqueous gel as coupling media as placebo or control group. The strengthening exercises like isometrics of quadriceps and isometric exercises of hip adductor muscles will use in 5 groups
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Main outcome variables
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Pain, stiffness, activities of daily living, and inflammation
General information
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Reason for update
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The only reason is to update the position of the Person responsible for Scientific Inquiry
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220615055179N3
Registration date:
2023-08-09, 1402/05/18
Registration timing:
registered_while_recruiting
Last update:
2023-11-23, 1402/09/02
Update count:
1
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Registration date
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2023-08-09, 1402/05/18
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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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2023-08-01, 1402/05/10
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Expected recruitment end date
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2023-09-30, 1402/07/08
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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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Formulation and Evaluation of Calotropis gigantea and Curcuma longa spray in Knee Osteoarthritis With And Without Phonophoresis
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Public title
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Formulation and Evaluation of Calotropis gigantea and Curcuma longa spray in Knee Osteoarthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
According to the Kellgren and Lawrence system of grading, patients with the grade 1-2-3 knee osteoarthritis
Age 45-70 years
Both gender
Exclusion criteria:
Neural defects
Injected with steroidal injections in the past 2 years
Rheumatoid arthritis
Total knee replacement
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Age
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From 45 years old to 70 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
150
More than 1 sample in each individual
Number of samples in each individual:
30
Participants will be equally distributed in five groups. 30 participants in each group.
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The lottery method will be used for the randomization of participants into five groups in which the names of participants will write on slips and put their name slips in the box, then will be selected independently by the 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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It is a single blinded study. The data analyser will be kept blind in order to avoid any biasness and for correct authentication and validation of the results.
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Placebo
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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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2023-07-10, 1402/04/19
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Ethics committee reference number
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2023/IRB/7/PT/06
Health conditions studied
1
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Description of health condition studied
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Osteoarthritis of Knee
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ICD-10 code
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M17. 9
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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Inflammation
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Timepoint
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Pre (before starting the intervention) and Post evaluation (after 3-4 weeks when treatment sessions/ intervention will be completed depending on different individual and conditions or grades of different individuals)
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Method of measurement
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Interleukin-6 and Tumor necrotic factor alpha
2
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Description
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Pain
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Timepoint
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Pre (before starting the intervention) and Post evaluation (daily after each treatment session, evaluation will be done)
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Method of measurement
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Numeric pain rating scale (NPRS) and Pain Catastrophizing Scale (PCS)
Secondary outcomes
1
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Description
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Stiffness, Pain and Activity of daily living
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Timepoint
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Pre (before starting the intervention) and Post evaluation (after every 3rd session of treatment, evaluation will be done)
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Method of measurement
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Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale
Intervention groups
1
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Description
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Intervention group 1: The first group will receive topical application of gel formulated from aqueous-methanolic (30:70) extracts of Calotropis gigantea (20%) and Curcuma longa (10%) through phonophoresis with therapeutic ultrasound (frequency of 0.8MH, and an intensity of about 1.5 W/cm2, and with the continuous mode) on the affected knee of participants. The gel will be used once.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: The second group will receive topical application of gel formulated from aqueous-methanolic (30:70) extracts of Calotropis gigantea (20%) and Curcuma longa (10%) through superficial massage on the affected knee of participants. The gel will be used once.
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Category
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Treatment - Drugs
3
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Description
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Control group 1: The third group will receive topical application of standard drug piroxicam 0.5% w/w gel through phonophoresis with therapeutic ultrasound (frequency of 0.8MH, and an intensity of about 1.5 W/cm2, and with the continuous mode) on the affected knee of participants. The gel will be used once.
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Category
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Treatment - Drugs
4
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Description
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Control group 2: The fourth group will receive topical application of standard drug piroxicam 0.5% w/w gel through superficial massage on the affected knee of participants. The gel will be used once.
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Category
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Treatment - Drugs
5
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Description
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Control group 3: The fifth group will be treated with therapeutic ultrasound (frequency of 0.8MH, and an intensity of about 1.5 W/cm2, and with the continuous mode) using aqueous gel as coupling media on the affected knee of participants. This will be used once.
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Category
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Placebo
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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567890
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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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100
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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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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not 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