Urolithiasis
Conditions
Keywords
Urolithiasis, Kalladaippu Kudineer, Siddha, Sindhuvallathy, Kidney stones
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 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
Interventions
DRUGSindhuvallathy mezhugu ( SVM)
500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation
DRUGKalladaippu Kudineer (KK) -
130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation
Sponsors
University Grants Commission
Tamilnadu Dr MGR Mecical University research council
Tamil Nadu Dr.M.G.R.Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expulsion of stones or Reduction in the number and size of the stones. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of stone forming factors within the study period. | 0,15th ,30th and 45th day | 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 | 0 15 30 45 days | Based on the reduction in the clinical symptoms |
| Changes in other investigations | 0 15th 30th 45th days | Changes in other laboratory parameters lipid profile renal profile urinary parameters etc will be measured |
Countries
India
Outcome results
None listed