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CTRI Number  CTRI/2014/10/005154 [Registered on: 30/10/2014] Trial Registered Prospectively
Last Modified On: 27/08/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Role of Barley in the treatment of Kidney Stones 
Scientific Title of Study   CLINICAL STUDY TO ASSESS THE THERAPEUTIC PROPERTIES OF AYURVEDIC FORMULATION OF HORDEUM VULGARE (Yava) IN THE MANAGEMENT OF RENAL CALCULI 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K V Chakradhar 
Designation  Ph.D Scholar 
Affiliation  Sri Venkateswara Ayurvedic Medical College and Hospital 
Address  Ph.D Scholar Department of Shalya Sri Venkateswara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati
Ph.D Scholar Department of Shalya Sri Venkateswara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati
Chittoor
ANDHRA PRADESH
517501
India 
Phone  919494100913  
Fax  08772240035  
Email  chakri52341@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K V Chakradhar 
Designation  Ph.D Scholar 
Affiliation  Sri Venkateswara Ayurvedic Medical College and Hospital 
Address  Ph.D Scholar Department of Shalya Sri Venkateswara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati
Ph.D Scholar Department of Shalya Sri Venkateswara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati
Chittoor
ANDHRA PRADESH
517501
India 
Phone  919494100913  
Fax  08772240035  
Email  chakri52341@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Dattatreya Rao 
Designation  Professor and Head 
Affiliation  Sri Venkateswara Ayurvedic Medical College and Hospital 
Address  Department of Shalya Sri Venkateswara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati
Department of Shalya Sri Venkateswara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati
Chittoor
ANDHRA PRADESH
517507
India 
Phone  91929133655  
Fax  08772240035  
Email  dattatreyadr1@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateswara Ayuvedic Medical College and Hospital Tirupati 
 
Primary Sponsor  
Name  Dr K V Chakradhar 
Address  Ph.D. Scholar Department of Shalya Sri Venkateshwara Ayurvedic Medical College and Hospital SVIMS Campus Tirupati 
Type of Sponsor  Other [Investigator initiated] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr KV Chakradhar  Department of Shalya  Sri Venkateswara Ayurvedic Medical College and Hospital Tirupati
Chittoor
ANDHRA PRADESH 
919494100913

chakri52341@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Venkateswara Medical College Tirupati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients suffering with all types of Renal Calculi,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hordeum vulgare (Yava)  This is an alkali substance, which is being prepared from the breads of barley with the procedure of Kşāra Nirmāņa Vidhi (SusrutaSamhita). Dry Yava Pancāňga (Whole plant of Barley) is divided into small pieces, ignited by sesame stalks (Tila oil plant) with pebbles of limestone. When the fire has burnt out, the ash and the slake lime should be collected separately. Then one Droņa (12.288 Kgs) of the ash should be dissolved in six Droņās of water and filtered 21 times and should be treated on fire in a big pan, while it is slowly stirred by a ladle. When it becomes clear, red, sharp and slimy, it should be filtered through a wide piece of cloth and the filtrate should be placed again on fire after removing the separated residue. This is the basic Yava kshara (alkali of Barley) which serve the main purpose. The pH of the final product is 11.2. 4 doses of the drug each consisting 250 mg was administered orally on weekly basis after mixing the drug in 200 ml of water.  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Sex: Either sex
• Radiological evidence of stone (>5 mm to <10 mm) in Kidney, Ureter and Urinary Bladder.
 
 
ExclusionCriteria 
Details  • Stone size more than 10 mm.
• Impacted stone.
• Gross Hydronephrosis.
• Pyelonephritis.
• Uncontrolled Diabetic Mellitus and Hypertension
• Malignancy.
• Impaired Renal Function.
• Poorly Functioning Kidney.
• Patients with obstruction in urinary passage.
• Patients with known metabolic abnormality for calculus formation (Hyperuraecemia).
• Any other complication of calculus.
• Patients undergoing treatment for any other serious illness.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. expulsion of the renal calculi  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. ability in reducing the size of the calculi
2. Improved quality of life
 
90 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/12/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Study outcome will be published in peer reviewed journals 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The incidence of renal calculi (urolithiasis) is increasing in both developed and developing countries. It is estimated that 12% of world population experiences renal stone disease with a recurrence rate of 70-80% in males and 47-60% in females.  Urolithiasis carries high risk of recurrence after the initial episode, of around 50% at 5 years and 70% at 9 years. Search for alternative medicines available at low cost which exhibit least adverse effects are anticipated to benefit many poor patients with renal calculi. It has been described in Ayurveda that Hordeum vulgare is effective in the expulsion of renal calculi. SuÅ›ruta the father of surgery explained urinary calculus under the heading of Ashmari in details including etiological factors, classification, symptomatology, pathology, complications and its management in a most scientific manner. This disease is dreadful and hence considered one of the ‘Mahāgadās’ by SuÅ›ruta, may be owing to its potentiality to disturb the anatomy and physiology of urinary system. The old bladder stone is reported at “ELAMARAH” in Upper Egypt, dated about 4800 BC, shows that humans of ancient time were undoubtedly affected with the disease Ashmari just as humans are now. Å–igveda and Atharavaveda (2000 – 5000 BC) also mentioned the stone and advise people not to ride a horse, Caraka has advised medical management and SuÅ›ruta advised both conservative and surgical removal of stone through perineal root cystolithotomy. All the Acharyas except Charaka have classified the disease MÅ«trāśmari into four types.

i.e. i.) Shleshmaja Ashmari

ii.) Pittaja Ashmari

iii.) Vataja Ashmari

iv) Shukraja Ashmari

Management of various types of Ashmari has been described in Suśruta Samhitā in view of the fatality of the diseases treatment has been advised to be undertaken in the early stages of the disease. Ghŗta recipes for three types of calculi have been mentioned along with indication of appropriate food, drinks and other measures, where he exclusively described about the usage of Yava Kshara. Indication for the surgical management has been given along with a note of caution regarding its dangers and doubtful chances of success. It was to be undertaken only on failure of conservative treatment and when death was inevitable if not treated surgically. However, there is no comprehensive analysis and the formulation has not been scientifically validated. Ours is the first attempt to validate the formulation described in Ayurveda. Development of new formulations which are likely to be cheaper and exhibit minimal or no adverse effects will be beneficial. The preliminary results advocate undertaking systematic scientific studies of the Hordeum vulgare formulation in the management of renal calculi. In view of the above facts and also the existing clinical trial data, it is proposed to validate the formulation through systematic studies.

 
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