A Clinical Study of Cystone Forte Tablet in treating Kidney stone
- Conditions
- Health Condition 1: N209- Urinary calculus, unspecified
- Registration Number
- CTRI/2017/12/010914
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Subject with Urolithiasis as diagnosed by clinical with calculi measuring 5 to 12 mm.
Hematologic and Biochemical parameters within normal limits (Study specific parameters: calcium, uric acid cannot be more than 2 times upper limit of normal value).Willing to sign inform consent document.
Subjects with severe obstructive uropathy,those with serious systemic medical disorder- Hypertension, Severe Diabetes, Metabolic disorders, Endocrinal disorders, cardiac illness,the subjects not to have used any drugs, for at least 1 week prior to the study for concurrent illness with diabetes and Hypertension.
Subjects with a strong history of food or drug allergy of any kind,Subjects not to have been on weight reducing diets within 3 months prior to the start of the study.Pregnant and lactating women
Patients unwilling to provide informed consent or abide by the requirements of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recovery in clinical symptoms and signs like Colicky pain at the loin, Hematuria, Dysuria, Nausea/vomiting, frequency of micturition, fever. <br/ ><br>ï??Improvement in laboratory parameters: Hematological, Biochemical, Urine, Radiological. <br/ ><br>Timepoint: Visit 0- Screening Visit <br/ ><br>Visit 1- At entry visit <br/ ><br>Visit 2- At the end of week 2 <br/ ><br>Visit 3- At the end of week 4 <br/ ><br>Visit 4- (End of the treatment) At the end of week 6
- Secondary Outcome Measures
Name Time Method Safety profile and overall compliance of Cystone forte tablet in Urolithiasis. <br/ ><br>Incidence of adverse events during the study period.Timepoint: Visit 0- Screening Visit <br/ ><br>Visit 1- At entry visit <br/ ><br>Visit 2- At the end of week 2 <br/ ><br>Visit 3- At the end of week 4 <br/ ><br>Visit 4- (End of the treatment) At the end of week 6