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IRCT20220615055179N4 IRCT 2024-12-27 Muhammad Nawaz Sharif University of Agriculture Evaluation of Brassica oleracea and Zingiber officinale Gel in Knee Osteoarthritis Formulation and Evaluation of Brassica oleracea and Zingiber officinale Gel in Knee Osteoarthritis 2025-01-12 anticipated 375 Complete https://irct.ir/trial/80929 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 be written 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 analyzer will be kept blind to avoid any biasness and for correct authentication and validation of the results. 2-3 Knee Osteoarthritis. Intervention 1: Group 1 will be treated with a test herbal gel 5% w/w with phonophoresis with therapeutic ultrasound (frequency of 0.8MH, and an intensity of about 1.5 W/cm2, and with the continuous mode) along with proprioceptive neuromuscular facilitation (PNF) stretching and muscle energy technique (MET) exercises for 3-4 weeks. Intervention 2: Group 2 will be treated with the standard drug piroxicam 0.5% w/w with phonophoresis with therapeutic ultrasound (frequency of 0.8MH, and an intensity of about 1.5 W/cm2, and with the continuous mode) along with proprioceptive neuromuscular facilitation (PNF) stretching and muscle energy technique (MET) exercises for 3-4 weeks. Intervention 3: Group 3 will be treated with therapeutic ultrasound using aqueous gel as coupling media as a placebo or control group placebo gel along with proprioceptive neuromuscular facilitation (PNF) stretching and muscle energy technique (MET) exercises for 3-4 weeks. 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 Qurat-Ul- Ain
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan
Multan Pakistan 66000 +92 303 9427506 qain0635@gmail.com Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan 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 knee osteoarthritis Both gender Age 40-70 years 40 years 70 years Both Neural defects Injected with steroidal injections in the past 2 years Rheumatoid arthritis Total knee replacement Tumors in the area of treatment The patients who are not co-operative during the study Fractures or any other orthopedic condition in the treatment limb M17.10 Unilateral primary osteoarthritis, unspecified knee Treatment - Drugs Treatment - Drugs Placebo Group 1 will be treated with a test herbal gel 5% w/w with phonophoresis with therapeutic ultrasound (frequency of 0.8MH, and an intensity of about 1.5 W/cm2, and with the continuous mode) along with proprioceptive neuromuscular facilitation (PNF) stretching and muscle energy technique (MET) exercises for 3-4 weeks. Group 2 will be treated with the standard drug piroxicam 0.5% w/w with phonophoresis with therapeutic ultrasound (frequency of 0.8MH, and an intensity of about 1.5 W/cm2, and with the continuous mode) along with proprioceptive neuromuscular facilitation (PNF) stretching and muscle energy technique (MET) exercises for 3-4 weeks. Group 3 will be treated with therapeutic ultrasound using aqueous gel as coupling media as a placebo or control group placebo gel along with proprioceptive neuromuscular facilitation (PNF) stretching and muscle energy technique (MET) exercises for 3-4 weeks. Inflammation. Timepoint: Pre (before starting the intervention) and Post evaluation (after 3-4 weeks when treatment sessions/ intervention will be completed depending on different individuals and conditions or grades of different individuals). Method of measurement: C-reactive protein (CRP), Interleukin-6, and Erythrocyte Sedimentation Rate (ESR). Pain. Timepoint: Pre (before starting the intervention) and Post evaluation (daily after each treatment session, evaluation will be done). Method of measurement: Visual Analog Scale (VAS), Numerical 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. Knee joint range of motion. Timepoint: Pre (before starting the intervention) and Post evaluation (after every 3rd session of treatment, evaluation will be done). Method of measurement: Goniometry. Muhammad Nawaz Sharif University of Agriculture Approved 2024-12-10 Ethic's Committee of Muhammad Institute of Medical and Allied Sciences, Multan. HBL street, near Sabzazar metro station, Bosan road. Multan Punjab Pakistan