Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594822
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
Effectiveness of Probiotics in Patients of Mild to Moderate Rheumatoid Arthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Probiotics and Standard Therapy Versus Standard Therapy Alone in Patients of Mild to Moderate Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the effectiveness of probiotics when given in combination with standard therapy in patients of mild to moderate rheumatoid arthritis
Detailed Description:
This study was conducted on the patients presenting to the Rheumatology out-patients department of the Department of Medicine King Edward Medical University Mayo hospital Lahore from 24th August 2023 till 23rd February 2024 A total of 88 patients of either sex between the age group of 18 to 70 years and having an established diagnosis of rheumatoid arthritis RA as proved on history X-rays and biologic markers like Rheumatoid Factor RF and Anti-cyclic citrullinated protein antibodies anti-CCP antibodies Erythrocyte Sedimentation Rate ESR and C- reactive protein CRP and having mild to moderate disease activity score DAS-28 score between 26 to 51 were selected via simple random sampling
After approval from the Board of Studies BOS and Advanced Study Research Board ASRB of King Edward Medical University Mayo Hospital Lahore all patients conforming to the selection criteria were enrolled in the study Informed written and verbal consent was taken from all the participants Patients demographic data was obtained and recorded in a predesigned proforma Patients were divided into two groups by computer generated method Group A comprised 44 patients who received standard therapy analgesics glucocorticoids any Disease modifying anti-rheumatic drug DMARD alongwith probiotic Bacillus clausii whereas Group B also comprising 44 patients received standard therapy alone Lab investigations like complete blood counts CBC C- reactive protein CRP liver function tests LFTs and renal function tests RFTs were done at baseline and then on follow up visits at 45 and 90 days Disease activity score DAS-28 was assessed on baseline then on each subsequent visit to monitor response to treatment Mild RA patients had a DAS-28 score between 26 to 31 and moderate RA patients had a DAS-28 score between 31 to 51 Effectiveness was defined in terms of reduction of DAS-28 score of 06 from the baseline based on European League against Rheumatism EULAR response rates Pancytopenia derangement in LFTs and RFTs twice from the baseline as a result of treatment resulted in exclusion from the study
Data was analyzed using computer software Statistical Package for Social Sciences SPSS version 260 Quantitative variables like age DAS-28 score were expressed as mean and standard deviation MeanSD Qualitative variables including gender were expressed as frequency and percentages Chi- square test was used to compare response between the two groups P value 005 was considered statistically significant
After approval from the Board of Studies BOS and Advanced Study Research Board ASRB of King Edward Medical University Mayo Hospital Lahore all patients conforming to the selection criteria were enrolled in the study Informed written and verbal consent was taken from all the participants Patients demographic data was obtained and recorded in a predesigned proforma Patients were divided into two groups by computer generated method Group A comprised 44 patients who received standard therapy analgesics glucocorticoids any Disease modifying anti-rheumatic drug DMARD alongwith probiotic Bacillus clausii whereas Group B also comprising 44 patients received standard therapy alone Lab investigations like complete blood counts CBC C- reactive protein CRP liver function tests LFTs and renal function tests RFTs were done at baseline and then on follow up visits at 45 and 90 days Disease activity score DAS-28 was assessed on baseline then on each subsequent visit to monitor response to treatment Mild RA patients had a DAS-28 score between 26 to 31 and moderate RA patients had a DAS-28 score between 31 to 51 Effectiveness was defined in terms of reduction of DAS-28 score of 06 from the baseline based on European League against Rheumatism EULAR response rates Pancytopenia derangement in LFTs and RFTs twice from the baseline as a result of treatment resulted in exclusion from the study
Data was analyzed using computer software Statistical Package for Social Sciences SPSS version 260 Quantitative variables like age DAS-28 score were expressed as mean and standard deviation MeanSD Qualitative variables including gender were expressed as frequency and percentages Chi- square test was used to compare response between the two groups P value 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None