Effect of Synbiotic supplementation as an add on therapy on clinical severity and quality of life in Indian patients with psoriasis- A double blind randomized controlled study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- -To evaluate the effect of synbiotic supplementation as an add on therapy, on the clinical severity of psoriasis using PASI ( Psoriasis area severity index) score over an 8 week period.
研究概览
简要总结
This is a randomized, double-blind, parallel group clinical trial evaluating the effect of synbiotic supplementation as an add-on to standard of care in Indian patients with psoriasis. Participants will be randomly assigned into two groups: Group A will receive synbiotic supplementation once daily for 8 weeks along with standard treatment of care, while Group B will receive (placebo -maltodextrin) along with standard treatment of care. The synbiotic contains a blend of lactobacillus acidophilus, lactobacillus rhamnosus, lactobacillus Casei, lactobacillus Plantarum, lactobacillus Bulgarious Bifidobacterium longum, Bifidobacterium Infantis, Bifidobacterium Breve, Streptococcus Thermophilus, with fructooligosaccharides . The primary outcome is to evaluate the change in Psoriasis Area Severity Index (PASI) from baseline to week 8. Secondary outcomes include change in Dermatology Life Quality Index (DLQI) and assessment of safety and acceptability of synbiotic supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 60 years either gender.
- •Clinically diagnosed with psoriasis and on stable treatment for the past 3 months.
- •Willingness to provide written informed consent.
排除标准
- •Patients requiring any change in the psoriasis medication during the study period.
- •Patients with other autoimmune or chronic inflammatory skin diseases -Patients on antibiotics, probiotics, prebiotics or synbiotic therapy within past 6 weeks .
- •Patients with history of gastrointestinal diseases ( Eg. IBD ,celiac disease) -Patients with severe comorbidity/ major systemic illness ( Eg. Uncontrolled diabetes, active malignancy) -History of immunosuppressive drug consumption except topical steroids -Pregnant and lactating women.
- •Known or suspected allergy or intolerance to probiotics, prebiotics, dairy proteins or supplement excipients.
- •Participation in another clinical trial within the past 30 days.
结局指标
主要结局
-To evaluate the effect of synbiotic supplementation as an add on therapy, on the clinical severity of psoriasis using PASI ( Psoriasis area severity index) score over an 8 week period.
时间窗: over an 8 week period.
次要结局
- -To assess the impact of synbiotic supplementation as an add on therapy, onthe quality of life on psoriasis patients using DLQI (Dermatology life quality index)(-To assess the patient safety and acceptability of synbiotic supplementation)
研究者
DrHarshitha Vani
Sri Manakula Vinayagar Medical College And Hospital