A Clinical Study to Evaluate the Efficacy of Two Siddha Drugs Sindhuvallathy Mezhugu and Kalladaippu Kudineer for Kidney Stones (SVMKK)
Primary Purpose
Urolithiasis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Sindhuvallathy mezhugu ( SVM)
Kalladaippu Kudineer (KK) -
Sponsored by
About this trial
This is an interventional treatment trial for Urolithiasis focused on measuring Urolithiasis, Kalladaippu Kudineer, Siddha, Sindhuvallathy, Kidney stones
Eligibility 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 .
Sites / Locations
- National Institute of Siddha
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Sindhuvallathy mezhugu
Kalladaippu Kudineer
Sindhuvallathy + Kalladaippu Kudineer
Arm Description
Sindhuvallathy mezhugu (SVM) 500 mg Twice daily per Oral 45 days duration
Kalladaippu Kudineer (KK) 130 ml decoction Twice daily Per oral 45 days Duration
Sindhuvallathy mezhu -500 mg capsules twice daily + Kalladaippu kudineer -130 ml decoction twice daily-per oral for 45 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Prevention of stone forming factors within the study period.
All the clinical parameters and Investigatory parameters will be assessed from baseline and in every follow up visit till 45 days.
Reduction in pain and symptom score
Based on the reduction in the clinical symptoms
Changes in other investigations
Changes in other laboratory parameters lipid profile renal profile urinary parameters etc will be measured
Full Information
NCT ID
NCT01847963
First Posted
April 23, 2013
Last Updated
December 30, 2014
Sponsor
Tamil Nadu Dr.M.G.R.Medical University
Collaborators
University Grants Commission, Tamilnadu Dr MGR Mecical University research council
1. Study Identification
Unique Protocol Identification Number
NCT01847963
Brief Title
A Clinical Study to Evaluate the Efficacy of Two Siddha Drugs Sindhuvallathy Mezhugu and Kalladaippu Kudineer for Kidney Stones
Acronym
SVMKK
Official Title
Standardization and Clinical Evaluation of Siddha Formulations for Urolithiasis /Kalladaippu.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tamil Nadu Dr.M.G.R.Medical University
Collaborators
University Grants Commission, Tamilnadu Dr MGR Mecical University research council
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
Urolithiasis, Kalladaippu Kudineer, Siddha, Sindhuvallathy, Kidney stones
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sindhuvallathy mezhugu
Arm Type
Experimental
Arm Description
Sindhuvallathy mezhugu (SVM) 500 mg Twice daily per Oral 45 days duration
Arm Title
Kalladaippu Kudineer
Arm Type
Experimental
Arm Description
Kalladaippu Kudineer (KK) 130 ml decoction Twice daily Per oral 45 days Duration
Arm Title
Sindhuvallathy + Kalladaippu Kudineer
Arm Type
Experimental
Arm Description
Sindhuvallathy mezhu -500 mg capsules twice daily + Kalladaippu kudineer -130 ml decoction twice daily-per oral for 45 days.
Intervention Type
Drug
Intervention Name(s)
Sindhuvallathy mezhugu ( SVM)
Intervention Description
500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation
Intervention Type
Drug
Intervention Name(s)
Kalladaippu Kudineer (KK) -
Other Intervention Name(s)
Sirupeelai kudineer
Intervention Description
130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation
Primary Outcome Measure Information:
Title
Expulsion of stones or Reduction in the number and size of the stones.
Description
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.
Time Frame
0,15,30,45 days post drug treatment
Secondary Outcome Measure Information:
Title
Prevention of stone forming factors within the study period.
Description
All the clinical parameters and Investigatory parameters will be assessed from baseline and in every follow up visit till 45 days.
Time Frame
0,15th ,30th and 45th day
Title
Reduction in pain and symptom score
Description
Based on the reduction in the clinical symptoms
Time Frame
0 15 30 45 days
Title
Changes in other investigations
Description
Changes in other laboratory parameters lipid profile renal profile urinary parameters etc will be measured
Time Frame
0 15th 30th 45th days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. K Rajalakshmi, M.D (s)
Organizational Affiliation
The Tamilnadu Dr. MGR. Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Siddha
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600 024
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Evaluate the Efficacy of Two Siddha Drugs Sindhuvallathy Mezhugu and Kalladaippu Kudineer for Kidney Stones
We'll reach out to this number within 24 hrs