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IRCT20230202057310N1 IRCT 2023-03-23 Muhammad Nawaz Sharif University of Agriculture Analgesic and anti-inflammatory effect of Jasminum sambac gel for musculoskeletal injuries with and without phonophoresis Formulation and evaluation of Jasminum sambac gel for musculoskeletal injuries with and without phonophoresis 2023-02-05 anticipated 200 Complete https://irct.ir/trial/68418 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2-3 Condition 1: Muscular injuries. Condition 2: Soft tissue injuries. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Intervention 4: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Imran Ahmad Khan
Agriculture Complex, Old Shuja Abad Rd,
Multan Pakistan 66000 +92 333 6120602 imranahmadkhandurrani@gmail.com Muhammad Nawaz Sharif University of Agriculture scientific Dr. Muhammad Asif Raza
Agriculture Complex, Old Shuja Abad Rd,
Multan Pakistan 66000 +92 333 5552614 asif.raza@mnsuam.edu.pk Muhammad Nawaz Sharif University of Agriculture Pakistan 1st and 2nd grade soft tissue injuries 16-70 years Both gender 16 years 70 years Both 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 M79.1 M79.9 Myalgia Soft tissue disorder, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs 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. 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. 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. 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. Pain. Timepoint: Pre and Post evaluation. Method of measurement: Numeric Pain Rating Scale. Activities of Daily Living. Timepoint: Pre and Post evaluation. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. Muhammad Nawaz Sharif University of Agriculture Approved 2023-01-21 Ethic's Committee of Muhammad Nawaz Shareef University of Agriculture, Multan. Agriculture Complex, Old Shuja Abad Rd, Multan Punjab Pakistan