Rh Disease
Conditions
Brief summary
The correlation of circulating serum miR-125ba and miR-146a expression and clinical response to green tea therapy were analysed in RA patients.Clinical response to green tea therapy for 24 weeks was calculated from DAS28 scores. Whereas , a decrease of 1.2 points or above in DAS28 scores at 24 weeks of treatment compared with baseline was defined as clinical response according to the EULAR response criteria.A ready-made solutions containing the primers and probes for human miR-146a and miR-125ba (Applied Biosystems, Foster City, CA) and real-time RT-PCR was estimated using an ABI 7300 system (Applied Bio systems).
Detailed description
1. participants: A total of 100 subjects (aged 18-65 years) who were diagnosed as RA with moderate to severe activity at the division of rheumatology and clinical immunology at Mansoura University were evaluated in this study. 2. patients were evaluated for therapeutic response at baseline and 12, and 24 weeks of green tea therapy. All patients with RA were subjected for estimation of ESR, CRP, disease activity score in 28 joints (DAS28), patient's global assessment (PGA), and health assessment questionnaire damage index (HAQ-DI) at each visits (0 week, 12 weeks, and 24 weeks). 3. Pain intensity was assessed by using a standard VAS of 100 mm previously validated to chronic and acute pains. 4. Clinical response to green tea therapy for 24 weeks was calculated from DAS28 scores. 5. human miR-146a and miR-125ba were isolated and subjected to RT-PCR analysis
Interventions
DIETARY_SUPPLEMENTGreen tea group
Sponsors
King Saud University
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* subjects (aged 18-65 years) who were diagnosed as RA with moderate to severe activity at the division of rheumatology and clinical immunology at Mansoura University, between 20 January/2015 and 20 September 2015 were recruited in this prospective study. * According to the diagnostic criteria of the American College of Rheumatology (Arnett et al., 1988), all patients classified as showing established RA for more than 8 years. * Only patients who had higher scores of DAS28-ESR, RA biomarkers, and established radiographic analysis, and were diagnosed with RA according to the 2010ACR/ EULAR classification criteria were included in this study.
Exclusion criteria
• Patients who received non-steroidal anti-inflammatory drugs, oral glucocorticoids, had a history of severe deformation of joint, pregnant or lactating women were excluded from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional status | change from baseline functional status at 24 weeks | It will be assessed using disease activity score -28 (DAS28) and pre-validated health assessment questionnaire damage index (HAQ-DI). For DAS28 score, the number of swelling joints count (SJC) (0-28) and tender joints count (TJC) (0-28) in all patients were examined and DAS28 scores were calculated . DAS28 values \> 2.6 and ≤ 3.2 was considered as low RA disease activity, values \> 3.2 and ≤ 5.1 was considered as moderate disease activity and those \> 5.1 was considered as high disease activity. In case of HAQ-DI, score calculation involves answering of eight domains(dressing, rising, eating, walking, hygiene, grip, reach and usual activities) with four point likert scale . SDAI values \> 3.3 and ≤11 was considered as low RA disease activity, values \> 11 and ≤ 26 was considered as moderate disease activity and those \> 26 was considered as high disease activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | change from baseline functional status at 24 weeks | It will be assessed using the visual analogue scale (VAS). The patients were asked to mark on the VAS scale of 0-10 cm according to their global assessment of pain. The physician marked on the VAS of 0-10 cm according to the physician global assessment. Patients with higher VAS scores were considered with greater pain intensity. |
| Abnormal cell physiology and the parthenogenesis of Rheumatoid arthritis (RA) | change from baseline functional status at 24 weeks | it will be assessed by estimating the role of micro ribonucleic acid (microRNAs) in maintaining immune and inflammatory responses. In this part, the expression of miRNAs was estimated by real-time polymerase chain reaction (RT-PCR) analysis, whereas serum samples of each patients were subjected to PCR analysis. Patients with higher miRNAs expressionshowed greater abnormal in cell physiology and the pathogenesis of RH. Whereas normal subjects (≤ 1.2), and abnormal subjects ( ˃ 1.2) |
Outcome results
None listed