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| ID | Type | Description | Link |
|---|---|---|---|
| BCR - 2043 | Other Grant/Funding Number | UGC minor project F.no 41-1432-2011 |
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| Name | Class |
|---|---|
| University Grants Commission | OTHER |
| Tamilnadu Dr MGR Mecical University research council | UNKNOWN |
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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.
Objectives:
Primary Objectives. To assess the efficacy of sindhu vallathy mezhugu and Kalladaippu kudineer in Urolithiasis.
Secondary objectives
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sindhuvallathy mezhugu | Experimental | Sindhuvallathy mezhugu (SVM) 500 mg Twice daily per Oral 45 days duration |
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| Kalladaippu Kudineer | Experimental | Kalladaippu Kudineer (KK) 130 ml decoction Twice daily Per oral 45 days Duration |
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| Sindhuvallathy + Kalladaippu Kudineer | Experimental | Sindhuvallathy mezhu -500 mg capsules twice daily + Kalladaippu kudineer -130 ml decoction twice daily-per oral for 45 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sindhuvallathy mezhugu ( SVM) | Drug | 500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0,15th ,30th and 45th day |
| Reduction in pain and symptom score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. K Rajalakshmi, M.D (s) | The Tamilnadu Dr. MGR. Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Siddha | Chennai | Tamil Nadu | 600 024 | India |
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| Kalladaippu Kudineer (KK) - | Drug | 130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation |
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Based on the reduction in the clinical symptoms |
| 0 15 30 45 days |
| Changes in other investigations | Changes in other laboratory parameters lipid profile renal profile urinary parameters etc will be measured | 0 15th 30th 45th days |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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