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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation
130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation
National Institute of Siddha
Chennai, Tamil Nadu, India
Expulsion of stones or Reduction in the number and size of the stones.
The recruited subjects will be assessed for their parameters from base line and 15th day 30th day and 45th day of drug treatment. It will be measured either the expulsion of stones and/or reduction in number and size of stones from the baseline. The Ultra sound abdomen or X-ray will be done on 0 day and 45th day only.
Time frame: 0,15,30,45 days post drug treatment
Prevention of stone forming factors within the study period.
All the clinical parameters and Investigatory parameters will be assessed from baseline and in every follow up visit till 45 days.
Time frame: 0,15th ,30th and 45th day
Reduction in pain and symptom score
Based on the reduction in the clinical symptoms
Time frame: 0 15 30 45 days
Changes in other investigations
Changes in other laboratory parameters lipid profile renal profile urinary parameters etc will be measured
Time frame: 0 15th 30th 45th days
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