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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General information
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Only the Position of the Person Responsible for Scientific Inquiry and Updating Data was changed.
Only the Position of the Person Responsible for Scientific Inquiry and Updating Data was changed.
Ethics committees
#1
2021-11-10, 1400/08/19
empty
2021-11-10 00:00:00
2021/IRB/2/PT/02
empty
2021/IRB/2/PT/02
Recruitment centers
#1
Name of recruitment center - English: Muhammad Physiotherapy and Rehabilitation Center, Multan
Name of recruitment center - Persian:
Full name of responsible person - English: Dr. Imran Ahmad Khan
Full name of responsible person - Persian:
Street address - English: HBL street near Sabzazar metro station
Street address - Persian:
City - English: Multan
City - Persian:
Province: Punjab
Country: Pakistan
Postal code: 60700
Phone: +92 303 9427506
Fax:
Email: qain0635@gmail.com
Web page address:
Name of recruitment center - English: Muhammad Physiotherapy and Rehabilitation Center, Multan
Name of recruitment center - Persian:
Full name of responsible person - English: Qurat-Ul- Ain
Full name of responsible person - Persian:
Street address - English: HBL street, Near Sabzazar Metro Station, Bosan Road, Multan Pakistan
Street address - Persian:
City - English: Multan
City - Persian:
Province: Punjab
Country: Pakistan
Postal code: 66000
Phone: +92 303 9427506
Fax:
Email: qain0635@gmail.com
Web page address:
Name of recruitment center - English: Muhammad Physiotherapy and Rehabilitation Center, Multan Name of recruitment center - Persian: Full name of responsible person - English: Dr. Imran Ahmad KhanQurat-Ul- Ain Full name of responsible person - Persian: Street address - English: HBL street near, Near Sabzazar metro stationMetro Station, Bosan Road, Multan Pakistan Street address - Persian: City - English: Multan City - Persian: Province: Punjab Country: Pakistan Postal code: 6070066000 Phone: +92 303 9427506 Fax: Email: qain0635@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Muhammad Institute of Medical and Allied Sciences, Multan
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Imran Ahmad Khan
Full name of responsible person - Persian:
Street address - English: HBL street near Sabzazar metro station
Street address - Persian:
City - English: Multan
City - Persian:
Province: Punjab
Country: Pakistan
Postal code: 60700
Phone: +92 303 9427506
Fax:
Email: qain0635@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Muhammad Nawaz Sharif University of Agriculture
Name of organization / entity - Persian:
Full name of responsible person - English: Imran Ahmad Khan
Full name of responsible person - Persian:
Street address - English: Agriculture Complex, Old Shuja Abad Road
Street address - Persian:
City - English: Multan
City - Persian:
Province: Punjab
Country: Pakistan
Postal code: 66000
Phone: +92 333 6120602
Fax:
Email: imranahmadkhandurrani@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Muhammad InstituteNawaz Sharif University of Medical and Allied Sciences, MultanAgriculture Name of organization / entity - Persian: Full name of responsible person - English: Dr. Imran Ahmad Khan Full name of responsible person - Persian: Street address - English: HBL street near Sabzazar metro stationAgriculture Complex, Old Shuja Abad Road Street address - Persian: City - English: Multan City - Persian: Province: Punjab Country: Pakistan Postal code: 6070066000 Phone: +92 303 9427506333 6120602 Fax: Email: qain0635imranahmadkhandurrani@gmail.com Web page address:
50
100
50100
Private
Public
privatepublic
Muhammad Institute of Medical and Allied Sciences, Multan
Muhammad Nawaz Sharif University of Agriculture
Muhammad InstituteNawaz Sharif University of Medical and Allied Sciences, MultanAgriculture
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Muhammad Institute of Medical and Allied Sciences, Multan
Name of organization / entity - Persian:
Full name of responsible person - English: Imran Ahmad Khan
Full name of responsible person - Persian:
Position - English: Assistant Professor
Position - Persian:
Latest degree: phd
Area of specialty/work: 41
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: HBL street near Sabzazar metro station
Street address - Persian:
City - English: Multan
City - Persian:
Province: Punjab
Province - English: Punjab
Province - Persian:
contact.provinces_available:
Country: Pakistan
Postal code: 66000
Phone: +92 303 9427506
Mobile: +92 333 6120602
Fax:
Email: qain0635@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Muhammad Nawaz Sharif University of Agriculture
Name of organization / entity - Persian:
Full name of responsible person - English: Imran Ahmad Khan
Full name of responsible person - Persian:
Position - English: Coordinator Department of Pharmacy
Position - Persian:
Latest degree: phd
Area of specialty/work: 41
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Agriculture Complex, Old Shuja Abad Road
Street address - Persian:
City - English: Multan
City - Persian:
Province: Punjab
Province - English: Punjab
Province - Persian:
contact.provinces_available:
Country: Pakistan
Postal code: 66000
Phone: +92 333 6120602
Mobile: +92 333 6120602
Fax:
Email: imranahmadkhandurrani@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Muhammad InstituteNawaz Sharif University of Medical and Allied Sciences, MultanAgriculture Name of organization / entity - Persian: Full name of responsible person - English: Imran Ahmad Khan Full name of responsible person - Persian: Position - English: Assistant ProfessorCoordinator Department of Pharmacy Position - Persian: Latest degree: phd Area of specialty/work: 41 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: HBL street near Sabzazar metro stationAgriculture Complex, Old Shuja Abad Road Street address - Persian: City - English: Multan City - Persian: Province: Punjab Province - English: Punjab Province - Persian: contact.provinces_available: Country: Pakistan Postal code: 66000 Phone: +92 303 9427506333 6120602 Mobile: +92 333 6120602 Fax: Email: qain0635imranahmadkhandurrani@gmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Muhammad Institute of Medical and Allied Sciences, Multan
Name of organization / entity - Persian:
Full name of responsible person - English: Imran Ahmad Khan
Full name of responsible person - Persian:
Position - English: Assistant Professor
Position - Persian:
Latest degree: phd
Area of specialty/work: 41
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: HBL street near Sabzazar metro station
Street address - Persian:
City - English: Multan
City - Persian:
Province: Punjab
Province - English: Punjab
Province - Persian:
contact.provinces_available:
Country: Pakistan
Postal code: 66000
Phone: +92 333 6120602
Mobile: +92 333 6120602
Fax:
Email: imranahmadkhandurrani@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Muhammad Nawaz Sharif University of Agriculture, Multan
Name of organization / entity - Persian:
Full name of responsible person - English: Muhammad Asif Raza
Full name of responsible person - Persian:
Position - English: Professor
Position - Persian:
Latest degree: phd
Area of specialty/work: 15
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Agriculture Complex, Old Shuja Abad Road
Street address - Persian:
City - English: Multan
City - Persian:
Province: Punjab
Province - English: Punjab
Province - Persian:
contact.provinces_available:
Country: Pakistan
Postal code: 66000
Phone: +92 333 6120602
Mobile: +92 333 6120602
Fax:
Email: asif.raza@edu.pk
Web page address:
contact.organization_id: Name of organization / entity - English: Muhammad InstituteNawaz Sharif University of Medical and Allied SciencesAgriculture, Multan Name of organization / entity - Persian: Full name of responsible person - English: Imran Ahmad KhanMuhammad Asif Raza Full name of responsible person - Persian: Position - English: Assistant Professor Position - Persian: Latest degree: phd Area of specialty/work: 4115 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: HBL street near Sabzazar metro stationAgriculture Complex, Old Shuja Abad Road Street address - Persian: City - English: Multan City - Persian: Province: Punjab Province - English: Punjab Province - Persian: contact.provinces_available: Country: Pakistan Postal code: 66000 Phone: +92 333 6120602 Mobile: +92 333 6120602 Fax: Email: imranahmadkhandurraniasif.raza@gmail.comedu.pk Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Bahria University Medical and Dental College, Karachi, Pakistan
Name of organization / entity - Persian:
Full name of responsible person - English: Muhammad Hashim
Full name of responsible person - Persian:
Position - English: Associate Professor
Position - Persian:
Latest degree: med_doctor
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Bahria University Medical and Dental College
Street address - Persian:
City - English: Karachi
City - Persian:
Province: Sindh
Province - English: Sindh
Province - Persian:
contact.provinces_available:
Country: Pakistan
Postal code: 70222
Phone: +92 300 7485741
Mobile: +92 300 7485741
Fax:
Email: muhammadhashimkhan0635@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Muhammad Nawaz Sharif University of Agriculture
Name of organization / entity - Persian:
Full name of responsible person - English: Qurat-Ul- Ain
Full name of responsible person - Persian:
Position - English: Lecturer
Position - Persian:
Latest degree: med_doctor
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Agriculture Complex, Old Shuja Abad Road
Street address - Persian:
City - English: Multan
City - Persian:
Province: Punjab
Province - English: Punjab
Province - Persian:
contact.provinces_available:
Country: Pakistan
Postal code: 66000
Phone: +92 303 9427506
Mobile: +92 303 9427506
Fax:
Email: qain0635@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: BahriaMuhammad Nawaz Sharif University Medical and Dental College, Karachi, Pakistanof Agriculture Name of organization / entity - Persian: Full name of responsible person - English: Muhammad HashimQurat-Ul- Ain Full name of responsible person - Persian: Position - English: Associate ProfessorLecturer Position - Persian: Latest degree: med_doctor Area of specialty/work: 4068 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Bahria University Medical and Dental CollegeAgriculture Complex, Old Shuja Abad Road Street address - Persian: City - English: KarachiMultan City - Persian: Province: SindhPunjab Province - English: SindhPunjab Province - Persian: contact.provinces_available: Country: Pakistan Postal code: 7022266000 Phone: +92 300 7485741303 9427506 Mobile: +92 300 7485741303 9427506 Fax: Email: muhammadhashimkhan0635qain0635@gmail.com Web page address:
Protocol summary
Study aim
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.
Design
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.
Settings and conduct
The study will be conducted at Muhammad Physiotherapy and Rehabilitation Center, Multan, Pakistan. After approval was obtained from the institutional ethical committee.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Pain, stiffness, activities of daily living, and inflammation
General information
Reason for update
Only the Position of the Person Responsible for Scientific Inquiry and Updating Data was changed.
Acronym
IRCT registration information
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
Registration date
2023-01-14, 1401/10/24
Registrant information
Name
Qurat-Ul- Ain
Name of organization / entity
Muhammad Nawaz Shareef University of Agriculture, Multan
Country
Pakistan
Phone
+92 303 9427506
Email address
quratulain@mimas.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-11, 1400/12/20
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
2021-12-15, 1400/09/24
Actual recruitment end date
2022-08-15, 1401/05/24
Trial completion date
2022-08-15, 1401/05/24
Scientific title
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
Public title
Formulation of Polyherbal Gel and Evaluation of Anti-nociceptive and Anti-inflammatory Activities
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 16 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
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.
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
The participants were blinded
Placebo
Not used
Assignment
Parallel
Other design features
NPRS and WOMAC scales used for evaluation of anti-nociceptive and anti-inflammatory activities in muscular and soft tissue injuries
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences, Multan
Street address
HBL street near Sabzazar metro station
City
Multan
Postal code
66000
Approval date
2021-11-10, 1400/08/19
Ethics committee reference number
2021/IRB/2/PT/02
Health conditions studied
1
Description of health condition studied
Muscular injuries
ICD-10 code
T14.6
ICD-10 code description
Primary disorders of muscles
Primary outcomes
1
Description
Pain
Timepoint
pre and post evaluation
Method of measurement
Numeric pain rating scale (NPRS)
Secondary outcomes
1
Description
Activities of daily living
Timepoint
Pre and post evaluation
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale
2
Description
Stiffness
Timepoint
Pre and post evaluation
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
3
Description
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.
Category
Treatment - Drugs
4
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Muhammad Physiotherapy and Rehabilitation Center, Multan
Full name of responsible person
Qurat-Ul- Ain
Street address
HBL street, Near Sabzazar Metro Station, Bosan Road, Multan Pakistan
City
Multan
Postal code
66000
Phone
+92 303 9427506
Email
qain0635@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture
Full name of responsible person
Imran Ahmad Khan
Street address
Agriculture Complex, Old Shuja Abad Road
City
Multan
Postal code
66000
Phone
+92 333 6120602
Email
imranahmadkhandurrani@gmail.com
Grant name
STUDENT FUND
Grant code / Reference number
567890
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Nawaz Sharif University of Agriculture
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture
Full name of responsible person
Imran Ahmad Khan
Position
Coordinator Department of Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Agriculture Complex, Old Shuja Abad Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imranahmadkhandurrani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture, Multan
Full name of responsible person
Muhammad Asif Raza
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Agriculture Complex, Old Shuja Abad Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
asif.raza@edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture
Full name of responsible person
Qurat-Ul- Ain
Position
Lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Agriculture Complex, Old Shuja Abad Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 303 9427506
Email
qain0635@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available