CTRI/2017/04/008435RecruitingPhase 2
A clinical study on kalladaippu (Urolithiasis) with the evaluation of siddha drug " Karpoora silasathu parpam "
Dr S Sarathkumar1 site in 1 country40 target enrollmentStarted: March 11, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Mainly assessed by reduction of clinical symptoms and comparing before and after treatment
Study Overview
Brief Summary
This is a single arm open clinical trial to study the safety and efficacy of Siddha trial drug Karpoora Kilasathu parpam. The trial drug is given 100 milli grams twice a day for 48 days. Clinical trial is conducted after conducting Preclinical toxicity study. The trial drug Karpoora silasathu parpam is mentioned in Agasthiyar chendhooram 300. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.History of Urolithiasis (with USG-Whole Abdomen reports) 2.Pain the Flank 3.Burning Micturition 4.Nausea 5.Vomiting 6.Oliguria 7.Dysuria 8.Haematuria 9.Fever 10.Stone size-4 to 10mm.
Exclusion Criteria
- •1.Hydro nephrosis 2.Stag horn calculus 3.Calculi associated with elevated serum creatinine level 4.Calculi in pregnancy.
Outcomes
Primary Outcomes
Mainly assessed by reduction of clinical symptoms and comparing before and after treatment
Time Frame: 48 days
Secondary Outcomes
- Any toxicity of the drug(14 days)
Investigators
Study Sites (1)
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