A Clinical study of Karasoodasathu Parpam in the management of Kalladaippu Noi (Urolithiasis)

Phase 2

Completed

• Conditions: Urinary calculus, unspecified,

• Registration Number: CTRI/2020/02/023632
• Lead Sponsor: Government Siddha Medical College and Hospital

Brief Summary

The study is a Prospective Open Labelled Phase II non-randomized clinical study to evaluate the  therapeutic efficacy of Karasoodasathu Parpam in the management of Kalladaippu Noi(Urolithiasis).The trial drug will be administered at the dose of 2.5 - 5mgKgBWTwice a day|AF for 45 days in 60 patients. The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital ,Palayamkottai,Tirunelveli,Tamilnadu.The primary outcome will be the evaluation of therapeutic efficacy of trial drug Karasoodasathu parpam. The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug,assessment of pharmacological and biochemical parameters of trial drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-03
• Last Update Posted: 2021-06-22
• Study Completion: 2021-12-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Renal colicky pain from loin to groin 2.Nausea and Vomiting 3.Haemeturia 4.Oliguria 5.Dysuria 6.Patients who are willing to undergo radiological Investigations and give blood for laboratory investigations.

Exclusion Criteria

1.Chronic Appendicitis 2.Cholecystitis 3.Pyelonephritis 4.Recurrent UTI 5.Diabetes mellitus 6.Metabolic disorders like Hyperthyroidism,Hyperparathyroidism 7.Pelvic inflammatory disease 8.Chronic Renal Failure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reduction in Severity of renal colicky pain,Nausea,Vomiting,Haematuria,Dysuria,Oliguria	45 days
2.Reduction in size of the kidney stone in USG Abdomen and pelvis(In selective patients)	45 days

Secondary Outcome Measures

Name	Time	Method
1.Evaluation of pharmacological ,Biochemical and Phytochemical analysis of trial drug.	2.Determination of safety profile of trial drug

Trial Locations

Locations (1)

Government Siddha Medical College and Hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government Siddha Medical College and Hospital

🇮🇳Tirunelveli, TAMIL NADU, India

K Soundarya

Principal investigator

9442534699

soundaryabalabsms@gmail.com