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

Urolithiasis Clinical Trial

— SVMKK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847963
• Other study ID #: MGR-10-KR- 1301
• Secondary ID: BCR - 2043
• Status: Completed
• Phase: N/A
• First received: April 23, 2013
• Last updated: December 30, 2014
• Start date: June 2012
• Est. completion date: October 2013

Study information

• Verified date: December 2014
• Source: Tamil Nadu Dr.M.G.R.Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Drug:
• Sindhuvallathy mezhugu ( SVM)
500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation
• Kalladaippu Kudineer (KK) -
130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation

Locations

Country	Name	City	State
India	National Institute of Siddha	Chennai	Tamilnadu

Sponsors (3)

Lead Sponsor	Collaborator
Tamil Nadu Dr.M.G.R.Medical University	Tamilnadu Dr MGR Mecical University research council, University grants commission

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Reduction in pain and symptom score	Based on the reduction in the clinical symptoms	0 15 30 45 days	No
Secondary	Changes in other investigations	Changes in other laboratory parameters lipid profile renal profile urinary parameters etc will be measured	0 15th 30th 45th days	Yes