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CTRI Number  CTRI/2020/11/029011 [Registered on: 10/11/2020] Trial Registered Prospectively
Last Modified On: 06/11/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two drugs Tila-Dhatri kshara along with Gokshura kashaya and Potassium Magnesium Citrate B6 in patients with Kidney stones. 
Scientific Title of Study   Evaluaton of Lithotriptic Activity of Tila- Dhatri Kshara along with Gokshura Kashaya in comparison with Potassium Magnesium Citrate-B6 in Urolithiasis - An Experimental & Clinical Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neethu Vijai 
Designation  PhD Scholar 
Affiliation  Banaras Hindu University 
Address  Department of Shalyatantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
PhD Scholar Room no.14 Ayurveda wing Sir Sunderlal Hospital IMS,BHU,Varanasi
Varanasi
UTTAR PRADESH
221005
India 
Phone  9496077201  
Fax    
Email  neeethurajeeev@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lakshman Singh 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Department of Shalyatantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Room no 12 Ayurveda wing Sir Sunderlal Hospital IMS,BHU,Varanasi
Varanasi
UTTAR PRADESH
221005
India 
Phone  9415687065  
Fax    
Email  drlsingh@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Lakshman Singh 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Department of Shalyatantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Room no 12 Ayurveda wing Sir Sunderlal Hospital IMS,BHU,Varanasi
Varanasi
UTTAR PRADESH
221005
India 
Phone  9415687065  
Fax    
Email  drlsingh@bhu.ac.in  
 
Source of Monetary or Material Support  
CCRAS (Central Council for Research in Ayurvedic Sciences) Ministry of Ayush, Govt of India, Room no 206, 2nd Floor, JLNBCHA Bhawan 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi - 110058 
 
Primary Sponsor  
Name  CCRAS 
Address  Central Council for Research in Ayurvedic Sciences(CCRAS) Ministry of AYUSH,Govt.of India Room No.206,2nd floor,JLNBCHA Bhavan Institutional Area,Opp.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 Neethu Vijai  Ayurveda wing, Sir Sunderlal Hospital  Shalyatantra OPD no 14 Ayurveda wing Sir Sunderlal Hospital,IMS,BHU,Varanasi.
Varanasi
UTTAR PRADESH 		 9496077201

neeethurajeeev@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, IMS, BHU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N20||Calculus of kidney and ureter. Ayurveda Condition: MOOTRASHMARI,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Potassium Magnesium Citrate-B6  Internal administration of Potassium Magnesium Citrate-B6 tab 1500mg twice daily morning and evening after food for 45 days 
Intervention  Tila-Dhatri kshara along with Gokshura kashaya Tila - Sesamum indicum,Pedaliaceae family Dhatri - Emblica officinalis,Euphorbiaceae family Gokshura - Tribulus terestris,Zygophyllaceae family   Internal administration of Tila-Dhatri kshara 500mg along with Gokshura kashaya 48ml two times daily morning and evening for 45 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients presenting with signs and symptoms of Urolithiasis confirmed radiologically.(stone size < 10mm)

2. Patients in the age group 18 – 70 yrs.

3. Patients of either sex.

4. Patients with informed consent. 
 
ExclusionCriteria 
Details  1. Stag horn renal calculi
2. Pyelonephritis
3. Uncontrolled diabetes mellitus
4. Malignancy
5. Chronic renal failure
6. Severe UTI
7. Calculus associated with complications
8. Calculi > 10mm
9. Bladder stones
10. Any other systemic symptoms like
hyperparathyroidism, gout etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Lithotriptic activity using S.T.O.N.E score assessed via NCCT Scan
Size
Topography
Obstruction
Number of stones
Evaluation of Hounsfield units 		 0th day and 46th day 
 
Secondary Outcome  
Outcome  TimePoints 
Pain using Wong-Baker Faces pain scale
Haematuria
Burning micturition 		 0th, 15th, 30th and 45th day 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 3 
Date of First Enrollment (India)   10/11/2020 
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="0"
Months="8"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
This study is a Non-randomized Active controlled trial to be conducted in 70 patients of Urolithiasis coming to the OPD of Sir Sunderlal Hospital ,IMS,BHU, Varanasi, Uttar Pradesh, India. The study is aimed at comparing the efficacy of ayurvedic drug with an allopathic drug. The 70 patients will be consecutively allocated in 2 groups of 35 patients each. One group will be given Tila-Dhatri kshara capsules 500mg along with Gokshura kashaya 48ml twice daily morning and evening before food for 45 days. The second group will be given Potassium Magnesium Citrate-B6 1500mg tablet twice daily morning and evening after food for 45 days. The primary outcome is lithotriptic activity which will be assessed by STONE score got through Non-Contrast CT scan on 0th and 46th day of drug administration. The SFR( Stone Free Rates ) is inversely proportional to the STONE score. The secondary outcome is subjective like Pain, Haematuria and Burning micturition. It will be assessed on 0th, 15th, 30th and 45th day of drug administration.

 
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