NCT01847963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

1.3 years

First QC Date

April 23, 2013

Last Update Submit

December 30, 2014

Conditions

Urolithiasis

Keywords

UrolithiasisKalladaippu KudineerSiddhaSindhuvallathyKidney stones

Outcome Measures

Primary Outcomes (1)

  • Expulsion of stones or Reduction in the number and size of the stones.

    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.

    0,15,30,45 days post drug treatment

Secondary Outcomes (3)

  • Prevention of stone forming factors within the study period.

    0,15th ,30th and 45th day

  • Reduction in pain and symptom score

    0 15 30 45 days

  • Changes in other investigations

    0 15th 30th 45th days

Study Arms (3)

Sindhuvallathy mezhugu

EXPERIMENTAL

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

Drug: Sindhuvallathy mezhugu ( SVM)

Kalladaippu Kudineer

EXPERIMENTAL

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

Drug: Kalladaippu Kudineer (KK) -

Sindhuvallathy + Kalladaippu Kudineer

EXPERIMENTAL

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

Drug: Sindhuvallathy mezhugu ( SVM)Drug: Kalladaippu Kudineer (KK) -

Interventions

Sindhuvallathy mezhugu ( SVM)DRUG

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

Sindhuvallathy + Kalladaippu KudineerSindhuvallathy mezhugu
Kalladaippu Kudineer (KK) -DRUG

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

Also known as: Sirupeelai kudineer
Kalladaippu KudineerSindhuvallathy + Kalladaippu Kudineer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\> 18 years
  • both gender
  • diagnosed ultrasonographically/radiographically with visible calculi of \>5mm
  • with or without clinical symptoms .

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Siddha

Chennai, Tamil Nadu, 600 024, India

Location

MeSH Terms

Conditions

UrolithiasisKidney Calculi

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephrolithiasisKidney DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Dr. K Rajalakshmi, M.D (s)

    The Tamilnadu Dr. MGR. Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 23, 2013

First Posted

May 7, 2013

Study Start

June 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 31, 2014

Record last verified: 2014-12

Locations

IN(1)