Urolithiasis Clinical Trial
Official 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.
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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