]>
IRCT20220615055179N1 IRCT 2023-01-14 Muhammad Nawaz Sharif University of Agriculture Formulation of Polyherbal Gel and Evaluation of Anti-nociceptive and Anti-inflammatory Activities Formulation of Polyherbal Gel and its Evaluation for Anti-nociceptive and Anti-inflammatory Activities in Sports Injuries with superficial massage and phonophoresis in comparison with diclofenac 2022-03-11 anticipated 200 Complete https://irct.ir/trial/64171 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: NPRS and WOMAC scales used for evaluation of anti-nociceptive and anti-inflammatory activities in muscular and soft tissue injuries, Randomization description: The lottery method was used for the randomization of participants into four groups in which the names of participants wrote on slips and put their name slips in the box, then selected independently by the lottery method, Blinding description: The participants were blinded. 2-3 Muscular injuries. Intervention 1: Intervention group-1: The first group received topical application of polyherbal gel, formulated from aqueous-methanolic (30:70) extracts Cinnamomum verum (2.8%), Curcuma longa (2.8%), Zingiber officinale (1.4%), Syzgium aromaticum (2.8%), Olea europaea (2.8%), Trachyspermum ammi (2.8%), Linum usitatissimum (2.8%), Sesamum indicum (2.8%), and Mentha piperita (1.2%), through phonophoresis with therapeutic ultrasound (continuous mode, 1 MH, 0.8W/cm2), on the affected areas of participants. The gel was used once and the data was collected through Numeric pain rating and The Western Ontario and McMaster Universities Arthritis Index scales. Intervention 2: Intervention group-2: The second group received topical application of polyherbal gel, formulated from aqueous-methanolic (30:70) extracts Cinnamomum verum (2.8%), Curcuma longa (2.8%), Zingiber officinale (1.4%), Syzgium aromaticum (2.8%), Olea europaea (2.8%), Trachyspermum ammi (2.8%), Linum usitatissimum (2.8%), Sesamum indicum (2.8%), and Mentha piperita (1.2%), through superficial massage on effected areas of participants. The gel was used once and the data was collected through NPRS and WOMAC scales. Intervention 3: Control group-1:The third group received diclofenac diethyl-ammonium 1% gel through phonophoresis with therapeutic ultrasound (continuous mode, 1 MH, 0.8W/cm2) on affected areas of participants. The gel was used once and the data was collected through NPRS and WOMAC scales. Intervention 4: Control group-2: The fourth group received diclofenac diethyl-ammonium 1% gel as control group-2 respectively through superficial massage on the affected areas of participants. The gel was used once and the data was 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 There is no further information
public Imran Ahmad Khan
Agriculture Complex, Old Shuja Abad Road
Multan Pakistan 66000 +92 333 6120602 imranahmadkhandurrani@gmail.com Muhammad Nawaz Sharif University of Agriculture scientific Muhammad Asif Raza
Agriculture Complex, Old Shuja Abad Road
Multan Pakistan 66000 +92 333 6120602 asif.raza@edu.pk Muhammad Nawaz Sharif University of Agriculture, Multan 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 for polyherbal gel formulation Skin problem Cancer Diabetic peripheral neuropathy Other neurological disorders Any type of bone fractures Open injuries Patients with casts Patients with splints T14.6 Primary disorders of muscles Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group-1: The first group received topical application of polyherbal gel, formulated from aqueous-methanolic (30:70) extracts Cinnamomum verum (2.8%), Curcuma longa (2.8%), Zingiber officinale (1.4%), Syzgium aromaticum (2.8%), Olea europaea (2.8%), Trachyspermum ammi (2.8%), Linum usitatissimum (2.8%), Sesamum indicum (2.8%), and Mentha piperita (1.2%), through phonophoresis with therapeutic ultrasound (continuous mode, 1 MH, 0.8W/cm2), on the affected areas of participants. The gel was used once and the data was collected through Numeric pain rating and The Western Ontario and McMaster Universities Arthritis Index scales. Intervention group-2: The second group received topical application of polyherbal gel, formulated from aqueous-methanolic (30:70) extracts Cinnamomum verum (2.8%), Curcuma longa (2.8%), Zingiber officinale (1.4%), Syzgium aromaticum (2.8%), Olea europaea (2.8%), Trachyspermum ammi (2.8%), Linum usitatissimum (2.8%), Sesamum indicum (2.8%), and Mentha piperita (1.2%), through superficial massage on effected areas of participants. The gel was used once and the data was collected through NPRS and WOMAC scales. Control group-1:The third group received diclofenac diethyl-ammonium 1% gel through phonophoresis with therapeutic ultrasound (continuous mode, 1 MH, 0.8W/cm2) on affected areas of participants. The gel was used once and the data was collected through NPRS and WOMAC scales. Control group-2: The fourth group received diclofenac diethyl-ammonium 1% gel as control group-2 respectively through superficial massage on the affected areas of participants. The gel was used once and the data was collected through NPRS and WOMAC scales. Pain. Timepoint: pre and post evaluation. Method of measurement: Numeric pain rating scale (NPRS). Activities of daily living. Timepoint: Pre and post evaluation. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. Stiffness. Timepoint: Pre and post evaluation. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. Muhammad Nawaz Sharif University of Agriculture Approved 2021-11-10 The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences, Multan HBL street near Sabzazar metro station Multan Punjab Pakistan