NCT01847963

A Clinical Study to Evaluate the Efficacy of Two Siddha Drugs Sindhuvallathy Mezhugu and Kalladaippu Kudineer for Kidney Stones

Standardization and Clinical Evaluation of Siddha Formulations for Urolithiasis /Kalladaippu.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Tamil Nadu Dr.M.G.R.Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Objectives: Primary Objectives. To assess the efficacy of sindhu vallathy mezhugu and Kalladaippu kudineer in Urolithiasis. Secondary objectives 1. To standardize the study drugs. 2. To observe the adverse effects if any Methods of proposed research: The consists of two segments Part - A. Non- clinical studies -standardisation of the study drugs. Part - B. Clinical studies. Study drugs 1. Sindhu Vallathy mezhugu will be prepared as per the literature Agasthiar vaidhya vallathy 600. 2. Kalldaippu Kudineer will be adapted from Athmaraktchamirtham Ennum Vaidhya Sarasangeeragam, 1968,page 349, 2.Siddha formulary of India part-II

Conditions

• Urolithiasis

Interventions

Type	Name	Description
DRUG	Sindhuvallathy mezhugu ( SVM)	500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation
DRUG	Kalladaippu Kudineer (KK) -	130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-05-07
• Last updated: 2014-12-31

Locations

1 site across 1 country: India