UrolithiasisSVMKKNCT01847963
A Clinical Study to Evaluate the Efficacy of Two Siddha Drugs Sindhuvallathy Mezhugu and Kalladaippu Kudineer for Kidney Stones
A study testing Sindhuvallathy mezhugu ( SVM) and Kalladaippu Kudineer (KK) - in people with Urolithiasis, run by Tamil Nadu Dr.M.G.R.Medical University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Sindhuvallathy mezhugu ( SVM) and Kalladaippu Kudineer (KK) -
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years
- both gender
- diagnosed ultrasonographically/radiographically with visible calculi of >5mm
- with or without clinical symptoms .
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standardization and Clinical Evaluation of Siddha Formulations for Urolithiasis /Kalladaippu.
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.
Read the 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
- Conditions
- Urolithiasis
- Being tested
- Sindhuvallathy mezhugu ( SVM), Kalladaippu Kudineer (KK) -
- Keywords
- Urolithiasis, Kalladaippu Kudineer, Siddha, Sindhuvallathy, Kidney stones
- Medical subject headings
- Urolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sindhuvallathy mezhugu ( SVM)Drug
500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation
Kalladaippu Kudineer (KK) -Drug
Also called Sirupeelai kudineer
130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation
| Study group | Role | What they receive |
|---|---|---|
| Sindhuvallathy mezhugu | Experimental | Sindhuvallathy mezhugu (SVM) 500 mg Twice daily per Oral 45 days duration Receives: Drug: Sindhuvallathy mezhugu ( SVM) |
| Kalladaippu Kudineer | Experimental | Kalladaippu Kudineer (KK) 130 ml decoction Twice daily Per oral 45 days Duration Receives: 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. Receives: Drug: Sindhuvallathy mezhugu ( SVM); Drug: Kalladaippu Kudineer (KK) - |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0,15,30,45 days post drug treatment
Secondary outcomes (3)
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.
Measured: 0,15th ,30th and 45th day
Reduction in pain and symptom score
Based on the reduction in the clinical symptoms
Measured: 0 15 30 45 days
Changes in other investigations
Changes in other laboratory parameters lipid profile renal profile urinary parameters etc will be measured
Measured: 0 15th 30th 45th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startJun 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tamil Nadu Dr.M.G.R.Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University Grants Commission, Tamilnadu Dr MGR Mecical University research council
- Responsible party
- Principal investigator, Dr. K. Rajalakshmi, Tamil Nadu Dr.M.G.R.Medical University
- Investigators
- Dr. K Rajalakshmi, M.D (s), Principal investigator, The Tamilnadu Dr. MGR. Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847963
- Sponsor's protocol ID
- MGR-10-KR- 1301
- Other IDs
- BCR - 2043
- Acronym
- SVMKK
- Status last verified
- Dec 2014
- First submitted
- 23 Apr 2013
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization and Clinical Evaluation of Siddha Formulations for Urolithiasis /Kalladaippu.
- ClinicalTrials.gov ID
- NCT01847963
- Acronym / sponsor ID
- SVMKK / MGR-10-KR- 1301
- Conditions
- Urolithiasis
- Keywords
- Urolithiasis, Kalladaippu Kudineer, Siddha, Sindhuvallathy, Kidney stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tamil Nadu Dr.M.G.R.Medical UniversityUniversity, hospital or other
- Collaborators
- University Grants Commission, Tamilnadu Dr MGR Mecical University research council
- Study start
- Jun 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sindhuvallathy mezhugu | Experimental | Drug: Sindhuvallathy mezhugu ( SVM)Sindhuvallathy mezhugu (SVM) 500 mg Twice daily per Oral 45 days duration |
| Kalladaippu Kudineer | Experimental | Drug: Kalladaippu Kudineer (KK) -Kalladaippu Kudineer (KK) 130 ml decoction Twice daily Per oral 45 days Duration |
| Sindhuvallathy + Kalladaippu Kudineer | Experimental | Drug: Sindhuvallathy mezhugu ( SVM), Drug: Kalladaippu Kudineer (KK) -Sindhuvallathy mezhu -500 mg capsules twice daily + Kalladaippu kudineer -130 ml decoction twice daily-per oral for 45 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age> 18 years
- both gender
- diagnosed ultrasonographically/radiographically with visible calculi of >5mm
- with or without clinical symptoms .
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sindhuvallathy mezhugu ( SVM)500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation | Drug | Sindhuvallathy + Kalladaippu Kudineer, Sindhuvallathy mezhugu |
| Kalladaippu Kudineer (KK) -Also: Sirupeelai kudineer130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation | Drug | Kalladaippu Kudineer, Sindhuvallathy + Kalladaippu Kudineer |
Primary outcome
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.
3 secondary outcomes
Prevention of stone forming factors within the study period.
Time frame: 0,15th ,30th and 45th day
Reduction in pain and symptom score
Time frame: 0 15 30 45 days
Changes in other investigations
Time frame: 0 15th 30th 45th days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. K Rajalakshmi, M.D (s) principal investigator
The Tamilnadu Dr. MGR. Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sindhuvallathy mezhugu ( SVM) and Kalladaippu Kudineer (KK) - in people with Urolithiasis, run by Tamil Nadu Dr.M.G.R.Medical University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expulsion of stones or Reduction in the number and size of the stones. (time frame: 0,15,30,45 days post drug treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.