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Evaluation of Therapeutic Potential of Curcumin With and Without Strengthening Exercises in improving Rheumatoid Arthritis

Protocol summary

Study aim
The objective of this study was to assess the synergistic effects of curcumin with and without strengthening exercises in rheumatoid arthritis patients.
Design
Pragmatic,community bases,parallel group,Double blinded,Randomised control trial. There were 100 patients were enrolled.Study was done form June-december 2021.Out of 100 patients 90 were selected.
Settings and conduct
Study was conducted at Muhammad Institute of Medical and Allied Sciences Multan after approval from institutional ethical comittee.
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
Treatment group A was treated with Curcumin and strengthening exercises, and control group B was treated with Curcumin only. Dosage of 180 mg/day of Curcumin The strengthening exercises given to group A were 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
By using WOMAC and NPRS,pain,stiffness and physical activities were measured.And at the end patient dependency and range of motion were also assessed.By using WOMAC and NPRS scale,pain stiffness and ADLs were the variables to be assessed. Morover,Xray finding were also done for the assessment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220401054388N1
Registration date: 2022-04-11, 1401/01/22
Registration timing: retrospective

Last update: 2022-04-11, 1401/01/22
Update count: 0
Registration date
2022-04-11, 1401/01/22
Registrant information
Name
Maliha Khalid Khan
Name of organization / entity
Ali –Ul- Murtaza Department of Rehabilitation Science, Muhammad Institute
Country
Pakistan
Phone
+92 333 6120602
Email address
drmalihatareen@mimas.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-18, 1400/03/28
Expected recruitment end date
2022-12-18, 1401/09/27
Actual recruitment start date
2021-06-01, 1400/03/11
Actual recruitment end date
2021-12-01, 1400/09/10
Trial completion date
2021-12-29, 1400/10/08
Scientific title
Evaluation of Therapeutic Potential of Curcumin With and Without Strengthening Exercises in improving Rheumatoid Arthritis
Public title
Curcumin With and Without Strengthening Exercises in Rheumatoid Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of all ages Diagnosed RA Both gender Patients with swelling in joints and pain
Exclusion criteria:
Vascular neoplasia Fibromyalgia Radiculopathy Neuropathy, Tumor, joint fractures, and vestibular problems
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 100
Actual sample size reached: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Double blinded study i-e randomization of participants in groups by lottery method and statistical analysis without biasness
Blinding (investigator's opinion)
Double blinded
Blinding description
Investigator and data analyser
Placebo
Not used
Assignment
Other
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
2021-02-02, 1399/11/14
Ethics committee reference number
MIMAS/28/IBR/Maliha

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,stiffness,Physical activities and joint deformity
Timepoint
6 weeks
Method of measurement
WOMAC and NPRS scale+ Radiographica; findings

Secondary outcomes

1

Description
Increase independency+ decrease in inflammatory biomarkers+ Immunity booster
Timepoint
6 weeks
Method of measurement
WOMAC and NPRS scale+lab investigations

Intervention groups

1

Description
Intervention group:Treatment group A was treated with Curcumin and strengthening exercises, and control group B was treated with Curcumin only. Curcumin was purchased from Khalid Nutraceuticals (Pvt.) LTD, Multan, Pakistan. Dosage of 180 mg/day of Curcumin followed by EFSA recommendations was given to patients.The strengthening exercises given to group A were 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.The treatment regimen for group A was distributed as 3 sessions per week; each session lasted for 45 minutes. There were total 18 sessions. And treatment duration was 6 weeks. And 180 mg/day orally Curcumin was given
Category
Other

2

Description
Control group: control group B was treated with Curcumin only.Curcumin was purchased from Khalid Nutraceuticals (Pvt.) LTD, Multan, Pakistan. Dosage of 180 mg/day of Curcumin followed by EFSA recommendations was given to patients.Treatment regimen was 6 weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali –Ul- Murtaza Department of Rehabilitation Science, Muhammad Institute
Full name of responsible person
Imran Ahmad Khan
Street address
HBL street Sabsazar Metro Station
City
Multan
Postal code
66000
Phone
+92 313 6827130
Email
imranahmadkhandurrani@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ali –Ul- Murtaza Department of Rehabilitation Science, MIMAS
Full name of responsible person
Imran Ahmad Khan
Street address
Hbl street sabsazar metro station
City
Multan
Postal code
66000
Phone
+92 312 6827130
Email
DrMalihatareen@mimas.edu.pk
Grant name
Student fund
Grant code / Reference number
26082022
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Instititutional Funding policy
Proportion provided by this source
50
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
Ali –Ul- Murtaza Department of Rehabilitation Science,MIMAS
Full name of responsible person
Imran Ahmad Khan
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Cardiovascular Pharmacology
Street address
Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 312 6827130
Email
imranahmadkhandurrani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ali –Ul- Murtaza Department of Rehabilitation Science,MIMAS
Full name of responsible person
Imran Ahmad Khan
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Cardiovascular Pharmacology
Street address
Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 312 6827130
Email
imranahmadkhandurrani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ali –Ul- Murtaza Department of Rehabilitation Science, Muhammad Institute
Full name of responsible person
Maliha Khalid Khan
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
142
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Fax
Email
DrMalihatareen@mimas.edu.pk

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
There is no further information
When the data will become available and for how long
There is no further information
To whom data/document is available
There is no further information
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
There is no further information
What processes are involved for a request to access data/document
There is no further information
Comments
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