Protocol summary
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Study aim
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The aim of our study is to evaluate the anti-nociceptive and anti-inflammatory effects of J. sambac gel with superficial massage and phonophoresis.
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Design
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A pragmatic, community-based study. A double-blinded, randomized controlled trial with a parallel group design of 200 patients, will enroll between February 2023 to April 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 institutional ethical committee.
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Participants/Inclusion and exclusion criteria
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Patients with 1st and 2nd grade muscular and soft tissue injuries will be included in this study. Both genders, aged 16-70 years. While patients have any type of allergy from the ingredients used in the formulation or other skin problems, cancer, diabetic peripheral neuropathy, other neurological disorder, any type of bone fractures or open injuries, patient with casts or splints will be excluded from this study.
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Intervention groups
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Participants will be equally distributed into four parallel groups. The first and second groups will receive topical application of J. sambac and diclofenac diethyl-ammonium 1% gel respectively through phonophoresis with therapeutic ultrasound, while the third and fourth groups will receive topical application of J. sambac gel and diclofenac diethyl-ammonium 1% gel respectively through superficial massage on effected areas of participants.
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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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Only the Position of the Person responsible for general inquiries is changed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230202057310N1
Registration date:
2023-03-23, 1402/01/03
Registration timing:
registered_while_recruiting
Last update:
2023-12-14, 1402/09/23
Update count:
1
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Registration date
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2023-03-23, 1402/01/03
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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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2023-02-05, 1401/11/16
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Expected recruitment end date
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2023-04-05, 1402/01/16
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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 Jasminum sambac gel for musculoskeletal injuries with and without phonophoresis
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Public title
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Analgesic and anti-inflammatory effect of Jasminum sambac gel for musculoskeletal injuries with and without phonophoresis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
1st and 2nd grade soft tissue injuries
16-70 years
Both gender
Exclusion criteria:
Any type of allergy from the ingredients used in our formulation
Skin problem
Cancer
Diabetic peripheral neuropathy
Other neurological disorders
Any type of bone fractures Patients with casts Open injuries Patients with splints
Patients with casts
Patients with splints
Open injuries
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Age
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From 16 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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- Investigator
- Data analyser
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Sample size
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Target sample size:
200
More than 1 sample in each individual
Number of samples in each individual:
50
Participants will be equally distributed in four groups. 50 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 four 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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Double blinded
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Blinding description
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It is a double blinded study. Both the investigator and the data analyser will be kept blind in order to avoid any biasness. To overcome the biasness of procedure the investigator will be kept blind and for the correct authentication and validation of the results data analyser will be kept blind.
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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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2023-01-21, 1401/11/01
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Ethics committee reference number
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2023/IRB/21/PT/01
Health conditions studied
1
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Description of health condition studied
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Muscular injuries
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ICD-10 code
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M79.1
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ICD-10 code description
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Myalgia
2
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Description of health condition studied
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Soft tissue injuries
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ICD-10 code
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M79.9
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ICD-10 code description
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Soft tissue disorder, unspecified
Primary outcomes
1
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Description
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Pain
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Timepoint
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Pre and Post evaluation
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Method of measurement
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Numeric Pain Rating Scale
Secondary outcomes
1
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Description
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Activities of Daily Living
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Timepoint
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Pre and Post evaluation
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Method of measurement
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Western Ontario and McMaster Universities Osteoarthritis 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) extract Jasminum sambac (10%) through phonophoresis with therapeutic ultrasound (continuous mode, 1 MH, 0.8W/cm2), on the affected areas of participants. The gel will be used once and the data will be collected through Numeric pain rating scale (NPRS) and The Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale.
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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 polyherbal gel, formulated from aqueous-methanolic (30:70) extract Jasminum sambac (10%), through superficial massage on effected areas of participants. The gel will be used once and the data will be collected through NPRS and WOMAC scales.
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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 diclofenac diethyl-ammonium 1% gel through phonophoresis with therapeutic ultrasound (continuous mode, 1 MH, 0.8W/cm2) on affected areas of participants. The gel will be used once and the data will be collected through NPRS and WOMAC scales.
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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 diclofenac diethyl-ammonium 1% gel through superficial massage on the affected areas of participants. The gel will be used once and the data will be collected through NPRS and WOMAC scales.
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Category
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Treatment - Drugs
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