A clinical study to evaluate the efficacy of seeds of Mimosa pudica in pravahika w.s.r. To Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Frequency of stool (Urgency)
研究概览
简要总结
In this study patient will be selected from OPD of Kaya chikitsa and Panchakarma of M.C. DAV hospital, Jalandhar.
Patient will be selected on the basis of Inclusion and exclusion criteria.
Routine investigations will be carried out before enrolling patient for the study.
Medicine (Lajjalu seeds) 2 gm tid (6gm daily) will be given to the patient for 8 weeks and the efficacy of Lajjalu seeds will be evaluated.
Patient will be assessed every two weeks and 2 weeks after completion of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Age: 18 Yrs to 60 Yrs
- •Gender: Male, female, transgender 3.Must sign the informed consent form
- •Documented diagnosis (based on Ayurvedic criteria, Sigmoidoscopy and biopsy) of ulcerative colitis
- •If treated with oral corticosteroids, dose must not increase 20 mg per day of Prednisolone or equivalent.
排除标准
- •1.Severe ulcerative colitis indicated by Disease Activity Index score of greater than 10 2.Presence of any other medical condition.
- •3.Participants receiving therapy with cyclosporin, anti-TNF therapy, or methotrexate within the last 2 months of screening.
- •4.History of chronic liver disease or baseline liver chemistries greater than the upper limit of normal 5.Diabetes mellitus requiring hypoglycemic agents 6.Has any of the following laboratory abnormalities: WBC < 3,000 per uL, Neutrophil < 1,000 cell/cu.mm, Platelets <75,000 per uL.
- •7.Participant is female and is pregnant or currently breastfeeding.
结局指标
主要结局
1.Frequency of stool (Urgency)
时间窗: 8 weeks
5.Weight loss
时间窗: 8 weeks
6.Appetite
时间窗: 8 weeks
7.Mental status
时间窗: 8 weeks
3.Pain abdomen and discomfort (Tenesmus)
时间窗: 8 weeks
2.Blood in stool (Bloody diarrhea)
时间窗: 8 weeks
4.Body strength
时间窗: 8 weeks
8.Sigmoidoscopy (Before and after the study)
时间窗: 8 weeks
9.Biopsy (Before and after the study)
时间窗: 8 weeks
次要结局
- Reduction in hospital visits after completing the trial(10 weeks)