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.

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

Inclusion Criteria:

• Age> 18 years
• both gender
• diagnosed ultrasonographically/radiographically with visible calculi of >5mm
• with or without clinical symptoms .

Exclusion Criteria:

• Patients with severe pain and not responding to pain killers
• Bilateral Calculi obstruction requiring immediate surgery,
• Existing renal failure,
• Pregnant and lactating women,
• Age<18 years,
• known hepatic and cardiac diseases,
• Subjects those who are not willing to give informed consent
• Women those who are planning for pregnancy .