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Clinical Trial 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.


Clinical Trial 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 ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01847963
Study type Interventional
Source Tamil Nadu Dr.M.G.R.Medical University
Contact
Status Completed
Phase N/A
Start date June 2012
Completion date October 2013

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