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NCT Number: NCT01847963

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

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.

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Key information

Conditions

Urolithiasis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Siddha

Chennai, Tamil Nadu, 600 024, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Sindhuvallathy mezhugu ( SVM)

Drug

500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation

Kalladaippu Kudineer (KK) -

Drug

130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation

Other names: Sirupeelai kudineer

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Reduction in pain and symptom score

    Time frame: 0 15 30 45 days

    Based on the reduction in the clinical symptoms

  3. 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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Tamilnadu Dr MGR Mecical University research council
  • University Grants Commission

Registry information

Official study title

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

Acronym: SVMKK

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 7, 2013
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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