Clinical trial NCT01847963: A Clinical Study to Evaluate the Efficacy of Two Siddha Drugs Sindhuvallathy Mezhugu and Kalladaippu Kudineer for Kidney Stones
Official title: Standardization and Clinical Evaluation of Siddha Formulations for Urolithiasis /Kalladaippu.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urolithiasis
Keywords: Urolithiasis
Kalladaippu Kudineer
Siddha
Sindhuvallathy
Kidney stones
Lead sponsor: Tamil Nadu Dr.M.G.R.Medical University
Sponsor class: OTHER
Collaborators: name: University Grants Commission
name: Tamilnadu Dr MGR Mecical University research council
First posted: 2013-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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 .

Primary outcomes:
measure: Expulsion of stones or Reduction in the number and size of the stones.
timeFrame: 0,15,30,45 days post drug treatment
Secondary outcomes:
measure: Prevention of stone forming factors within the study period.
timeFrame: 0,15th ,30th and 45th day
measure: Reduction in pain and symptom score
timeFrame: 0 15 30 45 days
measure: Changes in other investigations
timeFrame: 0 15th 30th 45th days
Other outcomes:
Locations:
city: Chennai
country: India
facility: National Institute of Siddha
state: Tamilnadu
Study officials:
affiliation: The Tamilnadu Dr. MGR. Medical University
name: Dr. K Rajalakshmi, M.D (s)
role: PRINCIPAL_INVESTIGATOR
References: