A Clinical Study to Evaluate the Efficacy of Two Siddha Drugs Sindhuvallathy Mezhugu and Kalladaippu Kudineer for Kidney Stones (SVMKK)

Tamil Nadu Dr.M.G.R.Medical University

Status: Completed

Conditions: Urolithiasis

Treatments: Drug: Sindhuvallathy mezhugu ( SVM); Drug: Kalladaippu Kudineer (KK) -

Study type: Interventional

Funder types: Other

Identifiers

NCT01847963

MGR-10-KR- 1301

BCR - 2043 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Sindhuvallathy mezhugu

Experimental group

Description:

Sindhuvallathy mezhugu (SVM) 500 mg Twice daily per Oral 45 days duration

Treatment:

Drug: Sindhuvallathy mezhugu ( SVM)

Kalladaippu Kudineer

Experimental group

Description:

Kalladaippu Kudineer (KK) 130 ml decoction Twice daily Per oral 45 days Duration

Treatment:

Drug: Kalladaippu Kudineer (KK) -

Sindhuvallathy + Kalladaippu Kudineer

Experimental group

Description:

Sindhuvallathy mezhu -500 mg capsules twice daily + Kalladaippu kudineer -130 ml decoction twice daily-per oral for 45 days.

Treatment:

Drug: Kalladaippu Kudineer (KK) -

Drug: Sindhuvallathy mezhugu ( SVM)