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
|
|
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
|
|
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. |