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IRCT20220615055179N3 IRCT 2023-08-09 Muhammad Nawaz Sharif University of Agriculture Formulation and Evaluation of Calotropis gigantea and Curcuma longa spray in Knee Osteoarthritis Formulation and Evaluation of Calotropis gigantea and Curcuma longa spray in Knee Osteoarthritis With And Without Phonophoresis 2023-08-01 anticipated 150 Complete https://irct.ir/trial/71346 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2-3 Osteoarthritis of Knee. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Intervention 4: 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. Intervention 5: 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. 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 Tehreem Saad Khan
HBL street, near Sabzazar metro station, Bosan road
Multan Pakistan 66000 +92 304 1774786 tehreemkhanb1@gmail.com Muhammad Institute of Medical and Allied Sciences, Multan scientific Imran Ahmad Khan
Agriculture Complex, Old Shuja Abad Road
Multan Pakistan 66000 +92 333 6120602 imran.ahmad@mnsuam.edu.pk Muhammad Nawaz Sharif University of Agriculture Pakistan According to the Kellgren and Lawrence system of grading, patients with the grade 1-2-3 knee osteoarthritis Age 45-70 years Both gender 45 years 70 years Both Neural defects Injected with steroidal injections in the past 2 years Rheumatoid arthritis Total knee replacement M17. 9 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo 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. 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. 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. 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. 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. Inflammation. Timepoint: 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). Method of measurement: Interleukin-6 and Tumor necrotic factor alpha. Pain. Timepoint: Pre (before starting the intervention) and Post evaluation (daily after each treatment session, evaluation will be done). Method of measurement: Numeric pain rating scale (NPRS) and Pain Catastrophizing Scale (PCS). Stiffness, Pain and Activity of daily living. Timepoint: Pre (before starting the intervention) and Post evaluation (after every 3rd session of treatment, evaluation will be done). Method of measurement: Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale. Muhammad Nawaz Sharif University of Agriculture Approved 2023-07-10 Ethic's Committee of Muhammad Institute of Medical and Allied Sciences, Multan. HBL street, near Sabzazar metro station, Bosan road Multan Punjab Pakistan