UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061078 |
|---|---|
| Receipt number | R000069889 |
| Scientific Title | IMPACT OF DISEASEMODIFYING ANTIRHEUMATIC DRUGS AND NUTRITIONAL INTERVENTIONS |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/27 12:42:13 |
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Basic information
Public title
IMPACT OF DISEASEMODIFYING ANTIRHEUMATIC DRUGS AND NUTRITIONAL INTERVENTIONS ALONE AND IN COMBINATION A SINGLE-BLINDED STUDY
Acronym
IMPACT OF DISEASEMODIFYING ANTIRHEUMATIC DRUGS AND NUTRITIONAL INTERVENTIONS
Scientific Title
IMPACT OF DISEASEMODIFYING ANTIRHEUMATIC DRUGS AND NUTRITIONAL INTERVENTIONS
Scientific Title:Acronym
IMPACT OF DISEASEMODIFYING ANTIRHEUMATIC DRUGS AND NUTRITIONAL INTERVENTIONS
Region
| Asia(except Japan) |
Condition
Condition
nil
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To contrast the impact of DMARDs, nutritional treatment, and their combination in reducing the disease activity in RA patients as measured by DAS28 scores at the end of 9 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DAS28 scores
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
DMARDs, nutritional treatment, and their combination
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed within previous 1 year
Key exclusion criteria
Other diseases, obesity etc
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | iftikhar |
| Middle name | |
| Last name | alam |
Organization
DEPARTMENT OF HUMAN NUTRITION AND DIETETICS
BACHA KHAN UNIVERSITY CHARSADDA
Division name
HND
Zip code
25000
Address
HND
TEL
00923455104041
iftikharalam@bkuc.edu.pk
Public contact
Name of contact person
| 1st name | iftikhar |
| Middle name | |
| Last name | alam |
Organization
Bacha Khan University Charsadda Pakistan
Division name
HND
Zip code
25000
Address
HND Bacha Khan University Charsadda Pakistan
TEL
00923455104041
Homepage URL
iftikharalam@bkuc.edu.pk
Sponsor or person
Institute
DEPARTMENT OF HUMAN NUTRITION AND DIETETICS
BACHA KHAN UNIVERSITY CHARSADDA
Institute
Department
Personal name
Funding Source
Organization
DEPARTMENT OF HUMAN NUTRITION AND DIETETICS
BACHA KHAN UNIVERSITY CHARSADDA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bacha Khan University Charsadda Pakistan
Address
Bacha Khan University Charsadda Pakistan
Tel
00923455104041
iftikharalam@bkuc.edu.pk
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 27 | Day |
Last modified on
| 2026 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069889
