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

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.

Study Overview

• Status: Completed
• Conditions: Urolithiasis
• Intervention / Treatment: Drug: Sindhuvallathy mezhugu ( SVM); Drug: Kalladaippu Kudineer (KK) -

Detailed 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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Tamilnadu
    • Chennai, Tamilnadu, India, 600 024
      • National institute of siddha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tamil Nadu Dr.M.G.R.Medical University
• Collaborators: University Grants Commission; Tamilnadu Dr MGR Mecical University research council
• Investigators: Principal Investigator: Dr. K Rajalakshmi, M.D (s), The Tamilnadu Dr. MGR. Medical University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 30, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Urolithiasis; Kidney stones; Kalladaippu Kudineer; Siddha; Sindhuvallathy
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: MGR-10-KR- 1301; BCR - 2043 (Other Grant/Funding Number: UGC minor project F.no 41-1432-2011)