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
|
|
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
|
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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 KÅŸÄra NirmÄņa Vidhi (SusrutaSamhita). Dry Yava PancÄňga (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 DroņÄs 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. Suśruta 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 ‘MahÄgadÄs’ 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. Ŗigveda and Atharavaveda (2000 –
5000 BC) also mentioned the stone and advise people not to ride a horse, Caraka
has advised medical management and Suśruta advised both conservative and
surgical removal of stone through perineal root cystolithotomy.
All the Acharyas except Charaka have classified the disease MÅ«trÄÅ›mari 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 SuÅ›ruta SamhitÄ in view of the fatality
of the diseases treatment has been advised to be undertaken in the early stages
of the disease. GhÅ—ta 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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