Protocol summary
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Study aim
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This study aimed to evaluate the anti-inflammatory and anti-nociceptive activities of the polyherbal gel consisting of Cinnamomum verum, Curcuma longa, Zingiber officinale, Syzgium aromaticum, Olea europaea, Trachyspermum ammi, Linum usitatissimum, Sesamum indicum, and Mentha piperita, with superficial massage and phonophoresis in comparison with diclofenac diethyl-ammonium.
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Design
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A pragmatic, community-based study.
A single-blinded, randomized controlled trial with a parallel group design of 200 patients, enrolled between March 2022 to August 2022.
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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 was obtained from the institutional ethical committee.
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Participants/Inclusion and exclusion criteria
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Patients already diagnosed with 1st and 2nd grade muscular and soft tissue injuries were included in this study. Patients of either sex, aged 16-70 years who are able to understand the procedure and respond, include in this study. While patients have any type of allergy from the ingredients used for polyherbal gel 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 were excluded from this study.
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Intervention groups
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Participants were equally distributed into four parallel groups. The first and second groups received topical application of polyherbal gel and diclofenac diethyl-ammonium 1% gel respectively through phonophoresis with therapeutic ultrasound, while the third and fourth groups received topical application of polyherbal 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 Scientific Inquiry and Updating Data was changed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220615055179N1
Registration date:
2023-01-14, 1401/10/24
Registration timing:
retrospective
Last update:
2023-12-16, 1402/09/25
Update count:
1
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Registration date
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2023-01-14, 1401/10/24
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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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2022-03-11, 1400/12/20
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Expected recruitment end date
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2022-08-11, 1401/05/20
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Actual recruitment start date
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2021-12-15, 1400/09/24
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Actual recruitment end date
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2022-08-15, 1401/05/24
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Trial completion date
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2022-08-15, 1401/05/24
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Scientific title
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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
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Public title
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Formulation of Polyherbal Gel and Evaluation of Anti-nociceptive and Anti-inflammatory Activities
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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 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
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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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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 were equally distributed in four groups. 50 participants in each group.
Actual sample size reached:
50
More than 1 sample in each individual
Actual sample size in each individual:
50
Participants were 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 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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The participants were blinded
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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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NPRS and WOMAC scales used for evaluation of anti-nociceptive and anti-inflammatory activities in muscular and soft tissue injuries
Ethics committees
1
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Ethics committee
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Approval date
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2021-11-10, 1400/08/19
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Ethics committee reference number
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2021/IRB/2/PT/02
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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T14.6
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ICD-10 code description
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Primary disorders of muscles
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 (NPRS)
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
2
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Description
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Stiffness
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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 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.
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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 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.
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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 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.
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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 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.
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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