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CTRI Number  CTRI/2015/02/005488 [Registered on: 02/02/2015] Trial Registered Prospectively
Last Modified On: 17/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Role of certain Ayurvedic Drugs in the management of kidney stone 
Scientific Title of Study   Clinical evaluation of Goksura churna and Sveta parpati in the Management of Mutrasmari (Urolithiasis) 
Trial Acronym  CEGCSPMM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Kumar Singh 
Designation  Research Officer Ay (Scientist 2) 
Affiliation  National Veterinary-Ayurveda Research Institute and Hospital Lucknow 
Address  National Veterinary-Ayurveda Research Institute and Hospital INS 106 Sec 25 Indira Nagar Lucknow
National Veterinary-Ayurveda Research Institute and Hospital INS 106, Sec 25 Indira Nagar Lucknow
Lucknow
UTTAR PRADESH
226016
India 
Phone  9532013013  
Fax  05222717801  
Email  drsksingh2005@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Kumar Singh 
Designation  Research Officer Ay (Scientist 2) 
Affiliation  National Veterinary-Ayurveda Research Institute and Hospital Lucknow 
Address  National Veterinary-Ayurveda Research Institute and Hospital INS 106 Sec 25 Indira Nagar Lucknow
National Veterinary-Ayurveda Research Institute and Hospital INS 106, Sec 25 Indira Nagar Lucknow
Lucknow
UTTAR PRADESH
226016
India 
Phone  9532013013  
Fax  05222717801  
Email  drsksingh2005@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjay Kumar Singh 
Designation  Research Officer Ay (Scientist 2) 
Affiliation  National Veterinary-Ayurveda Research Institute and Hospital Lucknow 
Address  National Veterinary-Ayurveda Research Institute and Hospital INS 106 Sec 25 Indira Nagar Lucknow
National Veterinary-Ayurveda Research Institute and Hospital INS 106, Sec 25 Indira Nagar Lucknow
Lucknow
UTTAR PRADESH
226016
India 
Phone  9532013013  
Fax  05222717801  
Email  drsksingh2005@yahoo.co.in  
 
Source of Monetary or Material Support  
National Veterinary Ayurveda Research Institute and Hospital, INS 106, Sec 25, Indira Nagar, Lucknow 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences CCRAS  
Address  Jawahar Lal Nehru Bhartiya Chikisa Evam Homeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri, New Delhi-110058 
Type of Sponsor  Research institution 
 
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 Sanjay Kumar Singh  National Veterinary Ayurveda Research Institute and Hospital Lucknow  INS 106, Sector 25, Indira Nagar
Lucknow
UTTAR PRADESH 
9532013013
05222717801
drsksingh2005@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of NVARIH Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N20-N23||Urolithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Goksura Churna (API – Part I Vol 1 Pg 40) Sveta Parpati( AFI-vol.-II:Page 195):   a.Goksura Churna (API – Part I Vol 1 Pg 40): Dose: 5gm. twice daily Route of Administration: Oral Time of Administration: Twice a day after food Anupana: Water Duration of therapy: 12 weeks b.Sveta Parpati( AFI-vol.-II:Page 195): Dose: 1gm. twice daily Route of Administration: Oral Time of Administration: Twice a day after food Anupana: Water Duration of therapy: 12 weeks  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age: Between 20-70 years
2. Sex: Either sex
3. Any three of the following signs and symptoms if present

i. Intermittant dull/colicky pain in back radiating from loin to groin, which increase on movements/ jerks
ii. Haematuria
iii. Frequency of micturition
iv.Burning micturition
4. Evidence of calculus as per modern diagnostic procedures
(Evidence of urolithiasis in any of the following)
-CT abdomen non-contrast
-U.S.G. KUB region
-Stone size <7mm.
 
 
ExclusionCriteria 
Details  1. Age: Below 20 and above 70 years
2. Serum creatinine 1.5mg%
3. Stag horn renal stone
4. Hydronephrosis
5. Pyelonephritis
6. Diabetes mellitus
7. Malignancy
8. Chronic renal failure
9. Severe urinary tract infection or any other infection
10. Impaired renal function
11. Any other complications of calculus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Decrease in the size of calculus or expulsion of calculus  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the clinical sign & symptoms of Mutrasmari (Urolithiasis)   3 years 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   16/02/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The trial result would be published by Central Council for Research in Ayurvedic Sciences at the end of the clinical trial 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Mutrasmari (urolithiasis) is the condition where urinary calculi are formed or located anywhere in the urinary system, or the process of forming stones in the kidney, bladder, and/or ureters (urinary tract). Mutrasmari is a common cause of haematuria, abdominal pain, pain in flank, or groin. It occurs in one in 20 people at some time in their lives. The stones form in the urine-collecting area (the pelvis) of the kidney and may range in size from tiny to staghorn stones the size of the renal pelvis itself. In Ayurveda, asmari is described as one of Mahagada. In industrialized countries 10% of men and 3% of women have the problem of Mutrasmari. It occurs in people aged 35-45 years, but the disease can affect anyone at any age.

During recent decades, pharmacologic intervention has become more effective in stone disease: drugs can control the pain of renal colic, interfere at various levels in development of Mutrasmari, and contribute to the expulsion of stones. It is well known that development of Mutrasmari is a multifactorial process influenced by environmental-nutritional factors (low urinary volume, diet rich in animal protein, etc) and metabolic alterations; i.e., hypercalciuria, hyperuricosuria, and deficiency of stone-inhibiting factors (citrate, magnesium, glycosaminoglycans [GAGs]). Specific drugs such as citrate, allopurinol, and thiazide represent highly effective treatments for the promoting factors. Surgical approaches like extracorporeal shockwave lithotripsy (SWL) and endourologic techniques are also common practices, now-a-days in its treatment.

Ayurvedic medicines have been used since ancient times for the prevention and treatment of various diseases in human.  Treatment of Mutrasmari in Ayurveda is an established therapy and free from operational hazards. It is the best alternative to lithotripsy (expensive) and operation. The stone size which is less than 7mm Ayurvedic drugs are very effective due to the litholytic property. This is proved by several research works. In the present study, clinical evaluation of Goksura churna and Sveta parpati in the patients of Mutrasmari will be carried out. These Ayurvedic drugs are very cost-effective, low risk (associated with mortality and morbidity) and not required for admission in the hospital.

 
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