A Clinical Study to Evaluate the Efficacy of Two Siddha Drugs Sindhuvallathy Mezhugu and Kalladaippu Kudineer for Kidney Stones
- Conditions
- Urolithiasis
- Interventions
- Drug: Sindhuvallathy mezhugu ( SVM)Drug: Kalladaippu Kudineer (KK) -
- Registration Number
- NCT01847963
- Lead Sponsor
- Tamil Nadu Dr.M.G.R.Medical University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Age> 18 years
- both gender
- diagnosed ultrasonographically/radiographically with visible calculi of >5mm
- with or without clinical symptoms .
- 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 .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sindhuvallathy + Kalladaippu Kudineer Sindhuvallathy mezhugu ( SVM) Sindhuvallathy mezhu -500 mg capsules twice daily + Kalladaippu kudineer -130 ml decoction twice daily-per oral for 45 days. Sindhuvallathy + Kalladaippu Kudineer Kalladaippu Kudineer (KK) - Sindhuvallathy mezhu -500 mg capsules twice daily + Kalladaippu kudineer -130 ml decoction twice daily-per oral for 45 days. Sindhuvallathy mezhugu Sindhuvallathy mezhugu ( SVM) Sindhuvallathy mezhugu (SVM) 500 mg Twice daily per Oral 45 days duration Kalladaippu Kudineer Kalladaippu Kudineer (KK) - Kalladaippu Kudineer (KK) 130 ml decoction Twice daily Per oral 45 days Duration
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
Trial Locations
- Locations (1)
National Institute of Siddha
🇮🇳Chennai, Tamilnadu, India