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

NCT ID: NCT01847963

Last Updated: 2014-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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

Conditions

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Urolithiasis

Keywords

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Urolithiasis Kalladaippu Kudineer Siddha Sindhuvallathy Kidney stones

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sindhuvallathy mezhugu

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

Group Type EXPERIMENTAL

Sindhuvallathy mezhugu ( SVM)

Intervention Type DRUG

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

Kalladaippu Kudineer

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

Group Type EXPERIMENTAL

Kalladaippu Kudineer (KK) -

Intervention Type DRUG

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

Sindhuvallathy + Kalladaippu Kudineer

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

Group Type EXPERIMENTAL

Sindhuvallathy mezhugu ( SVM)

Intervention Type DRUG

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

Kalladaippu Kudineer (KK) -

Intervention Type DRUG

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

Interventions

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Sindhuvallathy mezhugu ( SVM)

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

Intervention Type DRUG

Kalladaippu Kudineer (KK) -

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

Intervention Type DRUG

Other Intervention Names

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Sirupeelai kudineer

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Grants Commission

OTHER

Sponsor Role collaborator

Tamilnadu Dr MGR Mecical University research council

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Dr. K. Rajalakshmi

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. K Rajalakshmi, M.D (s)

Role: PRINCIPAL_INVESTIGATOR

The Tamilnadu Dr. MGR. Medical University

Locations

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National Institute of Siddha

Chennai, Tamil Nadu, India

Site Status

Countries

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India

Other Identifiers

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BCR - 2043

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MGR-10-KR- 1301

Identifier Type: -

Identifier Source: org_study_id