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

NCT01847963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-12-31

No results posted yet for this study

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.

Conditions

  • Urolithiasis

Interventions

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

Sponsors & Collaborators

  • University Grants Commission

    collaborator OTHER

  • Tamilnadu Dr MGR Mecical University research council

    collaborator UNKNOWN

  • Tamil Nadu Dr.M.G.R.Medical University

    lead OTHER

Principal Investigators

  • Dr. K Rajalakshmi, M.D (s) · The Tamilnadu Dr. MGR. Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847963 on ClinicalTrials.gov