Trial | NCT01847963  Report issue

Title

A Clinical Study to Evaluate the Efficacy of Two Siddha Drugs Sindhuvallathy Mezhugu and Kalladaippu Kudineer for Kidney Stones
Standardization and Clinical Evaluation of Siddha Formulations for Urolithiasis /Kalladaippu.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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.
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
Study Started
Jun 30
2012
Primary Completion
Oct 31
2013
Study Completion
Oct 31
2013
Last Update
Dec 31
2014
Estimate

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

Sindhuvallathy mezhugu Experimental

Sindhuvallathy mezhugu (SVM) 500 mg Twice daily per Oral 45 days duration

Kalladaippu Kudineer Experimental

Kalladaippu Kudineer (KK) 130 ml decoction Twice daily Per oral 45 days Duration

Sindhuvallathy + Kalladaippu Kudineer Experimental

Sindhuvallathy mezhu -500 mg capsules twice daily + Kalladaippu kudineer -130 ml decoction twice daily-per oral for 45 days.

Criteria 

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 .
No Results Posted