A clinical study to evaluate the efficacy of seeds of Mimosa pudica in pravahika w.s.r. To Ulcerative Colitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 1.Frequency of stool (Urgency)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Adaptive randomization, such as minimization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1.Frequency of stool (Urgency)
Time Frame: 8 weeks
5.Weight loss
Time Frame: 8 weeks
6.Appetite
Time Frame: 8 weeks
7.Mental status
Time Frame: 8 weeks
3.Pain abdomen and discomfort (Tenesmus)
Time Frame: 8 weeks
2.Blood in stool (Bloody diarrhea)
Time Frame: 8 weeks
4.Body strength
Time Frame: 8 weeks
8.Sigmoidoscopy (Before and after the study)
Time Frame: 8 weeks
9.Biopsy (Before and after the study)
Time Frame: 8 weeks
Secondary Outcomes
- Reduction in hospital visits after completing the trial(10 weeks)