Protocol summary

Study aim
This study aims to explore synergistic effects of Habe Asgand combined and isometric exercises interventions work together to improve physical function, reduce pain, and enhance the overall quality of life for individuals suffering from RA.
Design
Pragmatic, community based, parallel group, double blinded, randomised controlled trial. Total 70 patients will be randomised into three groups.
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: Adults (aged 25–60 years) diagnosed with rheumatoid arthritis (RA) based on ACR/EULAR 2010 classification criteria, Active disease symptoms with mild to moderate RA severity, Ability to follow an exercise regimen and adhere to treatment.
Intervention groups
Group A: will be given 1 tablet (500 mg) of Habb-e-Asgand, twice daily after meals, with lukewarm water for 12 weeks. Group B: will be treated with Isometric Exercise Intervention including quadriceps and hamstring isometric contractions (10-second holds, 10–15 repetitions per set), grip-strengthening exercises (squeezing a stress ball for 5–10 seconds, repeated 10–15 times).Each session lasts 30–40 minutes, with a focus on individual tolerance and gradual progression for 12 weeks. Group C will be given combined Intervention both Habb-e-Asgand regimen and isometric exercise protocol as described above.
Main outcome variables
Pain, stiffness, physical activities will be main outcome variables. By using Western Ontario and McMaster Universities (WOMAC) and Numeric Pain Rating Scale , pain stiffness and activities of daily living will be assessed. erythrocyte sedimentation rate, C-reactive protein, rheumatoid factotr will also be monitored. X-ray will also be done for the assessment of the joints with rheumatoid arthritis.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230202057310N14
Registration date: 2024-12-25, 1403/10/05
Registration timing: prospective

Last update: 2024-12-25, 1403/10/05
Update count: 0
Registration date
2024-12-25, 1403/10/05
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
2025-01-01, 1403/10/12
Expected recruitment end date
2025-04-04, 1404/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Synergistic Effects of Habb-e- Asgand and Isometric Exercises in Rheumatoid Arthritis Management
Public title
Habb-e- Asgand and Isometric Exercises in Rheumatoid Arthritis Management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults (aged 25–60 years) diagnosed with rheumatoid arthritis (RA) based on ACR/EULAR 2010 classification criteria Active disease symptoms with mild to moderate RA severity Ability to follow an exercise regimen Adherence to treatment. Patients with swelling in joints and pain
Exclusion criteria:
Severe or end-stage RA requiring surgical intervention Known allergies to herbal products or ingredients in Habb-e-Asgand Recent use of immunosuppressive drugs, other experimental therapies, or specific physiotherapy regimens. Pregnancy Lactation
Age
From 25 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation concealment occurs and patients will be recruited by using simple randomization through the Lottery method. lottery method carried out through sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Statistical analyser and outcome asessor will be kept blind so that the result obtained will be without biasness.Participants will be blinded. Both will be unaware of the type of treatments that will be evaluated after the completion of the intervention trial and they will be kept blind by not knowing about the effects and group detail
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
Multan
City
MULTAN
Postal code
66000
Approval date
2024-12-10, 1403/09/20
Ethics committee reference number
MIMAS/25/12/IAK

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
12 weeks
Method of measurement
WOMAC and NPRS scale

2

Description
Stiffness
Timepoint
12 weeks
Method of measurement
WOMAC scale

3

Description
Daily activities
Timepoint
12 weeks
Method of measurement
WOMAC scale

4

Description
Disease activity score
Timepoint
12 weeks
Method of measurement
Disease Activity Score (DAS28)

Secondary outcomes

1

Description
Decrease in inflammatory biomarkers
Timepoint
12 weeks
Method of measurement
ESR, CRP, RF

2

Description
Rheumatoid Arthritis Disability
Timepoint
12 weeks
Method of measurement
Rheumatoid Arthritis Disability Index (RADI)

3

Description
Swollen Joint Count
Timepoint
12 weeks
Method of measurement
Xrays

Intervention groups

1

Description
Intervention group: Group A: will be given 1 tablet (500 mg) of Habb-e-Asgand, twice daily after meals, with lukewarm water for 12 weeks
Category
Treatment - Drugs

2

Description
Intervention group: Group B: will be treated with Isometric Exercise Intervention including quadriceps and hamstring isometric contractions (10-second holds, 10–15 repetitions per set), grip-strengthening exercises (squeezing a stress ball for 5–10 seconds, repeated 10–15 times).Each session lasts 30–40 minutes, with a focus on individual tolerance and gradual progression
Category
Rehabilitation

3

Description
Intervention group: Group C will be given combined Intervention, participants will follow both the Habb-e-Asgand regimen and isometric exercise protocol as described above.
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
Komal Ammar Bukhari
Street address
Bosan Road
City
Multan
Postal code
Dr Maliha Khalid Kha
Phone
+92 312 6827130
Email
komalbukhari608@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Qurat Ul Ain
Street address
Bosan Road
City
Multan
Postal code
66000
Phone
+92 312 6827130
Email
qain0635@gmail.com
Grant name
Student fund
Grant code / Reference number
MIMAS/25/05/Khadija
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Proportion provided by this source
70
Public or private sector
Private
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, Pakistan.
Full name of responsible person
Maliha Khalid Khan
Position
Lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 312 6827130
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
Coordinator Department of Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Old shuja Abad road Multan
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, Pakistan.
Full name of responsible person
Khadija Noor
Position
Punjab
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 300 4197088
Email
khadijanoor2604@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
Undecided - It is not yet known if there will be a plan to make this available
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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