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

Study Overview
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Brief Summary
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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
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Objectives: Primary Objectives. To assess the efficacy of sindhu vallathy mezhugu and Kalladaippu kudineer in Urolithiasis. Secondary objectives To standardize the study drugs. 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 Sindhu Vallathy mezhugu will be prepared as per the literature Agasthiar vaidhya vallathy 600. Kalldaippu Kudineer will be adapted from Athmaraktchamirtham Ennum Vaidhya Sarasangeeragam, 1968,page 349, 2.Siddha formulary of India part-II

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

Conditions
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Urolithiasis

Intervention / Treatment
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* Drug: Sindhuvallathy mezhugu ( SVM)
* Drug: Kalladaippu Kudineer (KK) -


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sindhuvallathy mezhugu<br>Sindhuvallathy mezhugu (SVM) 500 mg Twice daily per Oral 45 days duration | Drug: Sindhuvallathy mezhugu ( SVM)<br>* 500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation<br>|
| Experimental: Kalladaippu Kudineer<br>Kalladaippu Kudineer (KK) 130 ml decoction Twice daily Per oral 45 days Duration | Drug: Kalladaippu Kudineer (KK) -<br>* 130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation<br>* Other names: Sirupeelai kudineer;|
| Experimental: Sindhuvallathy + Kalladaippu Kudineer<br>Sindhuvallathy mezhu -500 mg capsules twice daily + Kalladaippu kudineer -130 ml decoction twice daily-per oral for 45 days. | Drug: Sindhuvallathy mezhugu ( SVM)<br>* 500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation<br>Drug: Kalladaippu Kudineer (KK) -<br>* 130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation<br>* Other names: Sirupeelai kudineer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0,15,30,45 days post drug treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0,15th ,30th and 45th day | 
| Reduction in pain and symptom score | Based on the reduction in the clinical symptoms | 0 15 30 45 days | 
| Changes in other investigations | Changes in other laboratory parameters lipid profile renal profile urinary parameters etc will be measured | 0 15th 30th 45th days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kalladaippu Kudineer, Urolithiasis, Siddha, Sindhuvallathy, Kidney stones