A Clinical Trial to study the effect of the Drug Karpoora silasathu parpam in patients with kidney stones

Phase 2

Recruiting

• Conditions: Kalladaippu (Urolithiasis)

• Registration Number: CTRI/2017/04/008435
• Lead Sponsor: Dr S Sarathkumar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-11
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mainly assessed by reduction of clinical symptoms and comparing before and after treatment	48 days

Secondary Outcome Measures

Name	Time	Method
Any toxicity of the drug	14 days

Trial Locations

Locations (1)

Arignar Anna Hospital.,Govt.Siddha Medical College; 🇮🇳 Chennai, TAMIL NADU, India

Arignar Anna Hospital.,Govt.Siddha Medical College

🇮🇳Chennai, TAMIL NADU, India

Dr S Sarathkumar

Principal investigator

8939885695

sarathkumar197@gmail.com