History
# Registration date Revision Id
3 2024-05-27, 1403/03/07 303407
2 2023-12-12, 1402/09/21 288219
1 2023-09-13, 1402/06/22 278739
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  • Protocol summary

    The objective of this study is to assess the synergistic effects of majoon suranjaan with and without isometric exercises in rheumatoid arthritis patients.
    The objective of this study is to assess the synergistic effects of majoon-e-suranjaan with and without isometric exercises in rheumatoid arthritis patients.
    Control group A will be treated with majoon suranjaan only while treatment group-B will be treated with isometric exercises and majoon suranjaan. Dosage of 200 g/day of majoon suranjaan given twice a day after meal in the form of paste taken orally. Single dose is 100 g. The isometric exercises given to group B will be upper extremity resistive exercises, resistive hand training with the medicine ball, elbow, and shoulder resistive training by dumbbells. Lower extremity resistive exercises i-e resistive knee training by pressing soft rollers and ankle weights—upper extremity theraband strengthening exercises and lower extremity theraband strengthening exercises.
    Control group A will be treated with majoon-e-suranjaan only while treatment group-B will be treated with isometric exercises and majoon-e-suranjaan. Dosage of 5 gm twice a day of majoon-e-suranjaan given after meal in the form of paste taken orally. The isometric exercises given to group B will be upper extremity resistive exercises, resistive hand training with the medicine ball, elbow, and shoulder resistive training by dumbbells. Lower extremity resistive exercises i-e resistive knee training by pressing soft rollers and ankle weights—upper extremity theraband strengthening exercises and lower extremity theraband strengthening exercises.
  • General information

    2023-05-31, 1402/03/10
    2023-04-30, 1402/02/10
    2023-09-03, 1402/06/12
    2023-10-03, 1402/07/11
    Only the name of the organization sponsor/ Funding source was changed.
    please update
    Majoon Suranjaan and Isometric Exercises in improving Rheumatoid Arthritis
    Majoon-e-Suranjaan and Isometric Exercises in Improving Rheumatoid Arthritis
    Clinical Trial Analysis of Comperative Therapeutic Potential of Majoon Suranjaan and Isometric Exercises in improving Rheumatoid Arthritis
    Clinical Trial Analysis of Synergistic Therapeutic Potential of Majoon-e-Suranjaan and Isometric Exercises in Improving Rheumatoid Arthritis
  • Intervention groups

    #1
    Control group: Control group A will be treated with majoon suranjaan Dosage of 200 g/day of majoon suranjaan given twice a day after meal in the form of paste taken orally. Single dose is 100 g.
    Control group: Control group A will be treated with majoon-e-suranjaan Dosage of 5 gm twice a day of majoon-e-suranjaan after meal in the form of paste taken orally.
    #2
    Intervention group: Treatment group-B will be treated with isometric exercises and majoon suranjaan. Dosage of 200 g/day of majoon suranjaan given twice a day after meal in the form of paste taken orally. Single dose is 100 g. The isometric exercises given to group B will be upper extremity resistive exercises, resistive hand training with the medicine ball, elbow, and shoulder resistive training by dumbbells. Lower extremity resistive exercises i-e resistive knee training by pressing soft rollers and ankle weights—upper extremity theraband strengthening exercises and lower extremity theraband strengthening exercises.
    Intervention group: Treatment group-B will be treated with isometric exercises and majoon suranjaan. Dosage of 5 gm majoon suranjaan given twice a day after meal in the form of paste taken orally. The isometric exercises given to group B will be upper extremity resistive exercises, resistive hand training with the medicine ball, elbow, and shoulder resistive training by dumbbells. Lower extremity resistive exercises i-e resistive knee training by pressing soft rollers and ankle weights—upper extremity theraband strengthening exercises and lower extremity theraband strengthening exercises.
  • Person responsible for updating data

    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: Mudassir Irfan
    Full name of responsible person - Persian:
    Position - English: Final year student of DPT
    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: HBL street, Sbzazar metro station, Bosan road, Multan, Pakistan
    Street address - Persian:
    City - English: Multan
    City - Persian:
    Province: Punjab
    Province - English: Punjab
    Province - Persian:
    contact.provinces_available:
    Country: Pakistan
    Postal code: 66000
    Phone: +92 314 6122490
    Mobile: +92 314 6122490
    Fax:
    Email: muddaserirfan@gmail.com
    Web page address:
    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: Mudasar Irfan
    Full name of responsible person - Persian:
    Position - English: Final year student of DPT
    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: HBL street, Sbzazar metro station, Bosan road, Multan, Pakistan
    Street address - Persian:
    City - English: Multan
    City - Persian:
    Province: Punjab
    Province - English: Punjab
    Province - Persian:
    contact.provinces_available:
    Country: Pakistan
    Postal code: 66000
    Phone: +92 314 6122490
    Mobile: +92 314 6122490
    Fax:
    Email: muddaserirfan@gmail.com
    Web page address:

Protocol summary

Study aim
The objective of this study is to assess the synergistic effects of majoon-e-suranjaan with and without isometric exercises in rheumatoid arthritis patients.
Design
Pragmatic, community based, parallel group, single blinded, randomised controlled trial. Total 100 patients will be enrolled. Patients who met our inclusion criteria randomised into two groups. Control group-A and treatment group-B
Settings and conduct
At Muhammad Institute of Medical and Allied Sciences Multan after getting approval from institutional ethical committee.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients of all ages, diagnosed RA, of both gender, and patients with swelling in joints and pain. Exclusion criteria: Patients with vascular neoplasia, fibromyalgia, radiculopathy, neuropathy, tumor, joint fractures, and vestibular problems were excluded.
Intervention groups
Control group A will be treated with majoon-e-suranjaan only while treatment group-B will be treated with isometric exercises and majoon-e-suranjaan. Dosage of 5 gm twice a day of majoon-e-suranjaan given after meal in the form of paste taken orally. The isometric exercises given to group B will be upper extremity resistive exercises, resistive hand training with the medicine ball, elbow, and shoulder resistive training by dumbbells. Lower extremity resistive exercises i-e resistive knee training by pressing soft rollers and ankle weights—upper extremity theraband strengthening exercises and lower extremity theraband strengthening exercises.
Main outcome variables
Pain, stiffness and physical activities will be main outcome variables. And at the end patient dependency and range of motion will also be assessed. By using WOMAC and NPRS scale, pain stiffness and ADLs were the variables to be assessed. ESR will also be monitored. X-ray will also be done for the assessment of the joints with RA.

General information

Reason for update
please update
Acronym
IRCT registration information
IRCT registration number: IRCT20230202057310N5
Registration date: 2023-09-13, 1402/06/22
Registration timing: registered_while_recruiting

Last update: 2024-05-30, 1403/03/10
Update count: 2
Registration date
2023-09-13, 1402/06/22
Registrant information
Name
Imran Ahmad Khan
Name of organization / entity
Muhammad Nawaz Shareef University of Agriculture, Multan
Country
Pakistan
Phone
+92 333 6120602
Email address
imran.ahmad@mnsuam.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2023-10-03, 1402/07/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial Analysis of Synergistic Therapeutic Potential of Majoon-e-Suranjaan and Isometric Exercises in Improving Rheumatoid Arthritis
Public title
Majoon-e-Suranjaan and Isometric Exercises in Improving Rheumatoid Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of all ages Diagnosed RA patients Both genders patients with swelling in joints and pain.
Exclusion criteria:
Patients with vascular neoplasia Fibromyalgia Radiculopathy Neuropathy Tumor Joint fractures Vestibular problems
Age
From 25 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of participants in groups by lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blinded study. Statistical analyser will be kept blind so that the result obtained will be without biasness.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences,
Street address
HBL Street near Sabsazar Metro Station
City
Multan
Postal code
66000
Approval date
2023-05-01, 1402/02/11
Ethics committee reference number
MIMAS/0510/IAK Durrani

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor

Primary outcomes

1

Description
Pain
Timepoint
24 weeks
Method of measurement
WOMAC and NPRS scale+ Radiographical findings

2

Description
Stiffness
Timepoint
24 weeks
Method of measurement
WOMAC scale scores

3

Description
Daily activities
Timepoint
24 weeks
Method of measurement
WOMAC scale score

Secondary outcomes

1

Description
Increase independency
Timepoint
24 weeks
Method of measurement
WOMAC scale

2

Description
decrease in inflammatory biomarkers
Timepoint
24 weeks
Method of measurement
Lab investigations

Intervention groups

1

Description
Control group: Control group A will be treated with majoon-e-suranjaan Dosage of 5 gm twice a day of majoon-e-suranjaan after meal in the form of paste taken orally.
Category
Treatment - Drugs

2

Description
Intervention group: Treatment group-B will be treated with isometric exercises and majoon suranjaan. Dosage of 5 gm majoon suranjaan given twice a day after meal in the form of paste taken orally. The isometric exercises given to group B will be upper extremity resistive exercises, resistive hand training with the medicine ball, elbow, and shoulder resistive training by dumbbells. Lower extremity resistive exercises i-e resistive knee training by pressing soft rollers and ankle weights—upper extremity theraband strengthening exercises and lower extremity theraband strengthening exercises.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Muhammad physical therapy clinic and rehabilitation center, Multan
Full name of responsible person
Qurat-ul-Ain
Street address
HBL street, near Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Postal code
66000
Phone
+92 312 6827130
Email
qain0635@gmail.com

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 Rd,
City
Multan
Postal code
66000
Phone
+92 333 6120602
Email
imranahmadkhandurrani@gmail.com
Grant name
Student fund
Grant code / Reference number
MNSUAM/26/05/Mudassir
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
70
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 Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Maliha Khalid Khan
Position
Demonstrator
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
HBL street, Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Province
Punjab
Postal code
66000
Phone
0312682671230
Email
malihatareen1997@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture, Multan, Pakistan
Full name of responsible person
Imran Ahmad Khan
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Old Shujabad road, Multan, Pakistan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imran.ahmad@mnsuam.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Mudasar Irfan
Position
Final year student of DPT
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
HBL street, Sbzazar metro station, Bosan road, Multan, Pakistan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 314 6122490
Email
muddaserirfan@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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