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

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ClinicalTrials.gov Identifier: NCT01847963
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : December 31, 2014
Sponsor:
Collaborators:
University Grants Commission
Tamilnadu Dr MGR Mecical University research council
Information provided by (Responsible Party):
Dr. K. Rajalakshmi, Tamil Nadu Dr.M.G.R.Medical University

Tracking Information
First Submitted Date  ICMJE April 23, 2013
First Posted Date  ICMJE May 7, 2013
Last Update Posted Date December 31, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
Expulsion of stones or Reduction in the number and size of the stones. [ Time Frame: 0,15,30,45 days post drug treatment ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
  • Prevention of stone forming factors within the study period. [ Time Frame: 0,15th ,30th and 45th day ]
    All the clinical parameters and Investigatory parameters will be assessed from baseline and in every follow up visit till 45 days.
  • Reduction in pain and symptom score [ Time Frame: 0 15 30 45 days ]
    Based on the reduction in the clinical symptoms
  • Changes in other investigations [ Time Frame: 0 15th 30th 45th days ]
    Changes in other laboratory parameters lipid profile renal profile urinary parameters etc will be measured
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Evaluate the Efficacy of Two Siddha Drugs Sindhuvallathy Mezhugu and Kalladaippu Kudineer for Kidney Stones
Official Title  ICMJE Standardization and Clinical Evaluation of Siddha Formulations for Urolithiasis /Kalladaippu.
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urolithiasis
Intervention  ICMJE
  • 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 Name: Sirupeelai kudineer
Study Arms  ICMJE
  • Experimental: Sindhuvallathy mezhugu
    Sindhuvallathy mezhugu (SVM) 500 mg Twice daily per Oral 45 days duration
    Intervention: Drug: Sindhuvallathy mezhugu ( SVM)
  • Experimental: Kalladaippu Kudineer
    Kalladaippu Kudineer (KK) 130 ml decoction Twice daily Per oral 45 days Duration
    Intervention: Drug: Kalladaippu Kudineer (KK) -
  • Experimental: Sindhuvallathy + Kalladaippu Kudineer
    Sindhuvallathy mezhu -500 mg capsules twice daily + Kalladaippu kudineer -130 ml decoction twice daily-per oral for 45 days.
    Interventions:
    • Drug: Sindhuvallathy mezhugu ( SVM)
    • Drug: Kalladaippu Kudineer (KK) -
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2014)
120
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2013)
90
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01847963
Other Study ID Numbers  ICMJE MGR-10-KR- 1301
BCR - 2043 ( Other Grant/Funding Number: UGC minor project F.no 41-1432-2011 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. K. Rajalakshmi, Tamil Nadu Dr.M.G.R.Medical University
Study Sponsor  ICMJE Tamil Nadu Dr.M.G.R.Medical University
Collaborators  ICMJE
  • University Grants Commission
  • Tamilnadu Dr MGR Mecical University research council
Investigators  ICMJE
Principal Investigator: Dr. K Rajalakshmi, M.D (s) The Tamilnadu Dr. MGR. Medical University
PRS Account Tamil Nadu Dr.M.G.R.Medical University
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP