Urolithiasis Clinical Trial
— SVMKKOfficial title:
Standardization and Clinical Evaluation of Siddha Formulations for Urolithiasis /Kalladaippu.
This study is a non randomized non comparative study with two Siddha formulations Sindhuvallathy Mezhugu and Kalladaippu Kudineer are available in Siddha classical texts existing for longer period. But there is no scientific data is documented about these formulations. This study aimed to evaluate the efficacy of the study drugs for urolithiasis. After the preliminary drug standardization the clinical study is Started at The National Institute of Siddha Tambaram. The primary outcome measure is either the Expulsion of stones or Changes in the number and size of the stones with 45 days drug treatment.
Status | Completed |
Enrollment | 120 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age> 18 years - both gender - diagnosed ultrasonographically/radiographically with visible calculi of >5mm - with or without clinical symptoms . Exclusion Criteria: - Patients with severe pain and not responding to pain killers - Bilateral Calculi obstruction requiring immediate surgery, - Existing renal failure, - Pregnant and lactating women, - Age<18 years, - known hepatic and cardiac diseases, - Subjects those who are not willing to give informed consent - Women those who are planning for pregnancy . |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | National Institute of Siddha | Chennai | Tamilnadu |
Lead Sponsor | Collaborator |
---|---|
Tamil Nadu Dr.M.G.R.Medical University | Tamilnadu Dr MGR Mecical University research council, University grants commission |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Expulsion of stones or Reduction in the number and size of the stones. | The recruited subjects will be assessed for their parameters from base line and 15th day 30th day and 45th day of drug treatment. It will be measured either the expulsion of stones and/or reduction in number and size of stones from the baseline. The Ultra sound abdomen or X-ray will be done on 0 day and 45th day only. | 0,15,30,45 days post drug treatment | Yes |
Secondary | Prevention of stone forming factors within the study period. | All the clinical parameters and Investigatory parameters will be assessed from baseline and in every follow up visit till 45 days. | 0,15th ,30th and 45th day | Yes |
Secondary | Reduction in pain and symptom score | Based on the reduction in the clinical symptoms | 0 15 30 45 days | No |
Secondary | Changes in other investigations | Changes in other laboratory parameters lipid profile renal profile urinary parameters etc will be measured | 0 15th 30th 45th days | Yes |
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