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CTRI Number  CTRI/2025/02/081307 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 17/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to compare the effects of Gokshuradi tablets and Cystone tablets in reducing urinary calculi size of selected Urolithiasis participants in the age group of 20 to 65 years: A Randomized Controlled Trial 
Scientific Title of Study   Efficacy of Gokshuradi tablet in Urolithiasis: A Randomized Controlled Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aswathy G 
Designation  PG scholar 
Affiliation  Govt. Ayurveda College Thiruvananthapuram 
Address  Department of Dravyagunavigyan Govt Ayurveda College Trivandrum Kerala India. 695001

Thiruvananthapuram
KERALA
695001
India 
Phone  8301025548  
Fax    
Email  aswathy1998geetha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr A Shahul Hameed 
Designation  Professor and HOD 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Dravyagunavigyan Govt Ayurveda College Trivandrum Kerala India.695001

Thiruvananthapuram
KERALA
695001
India 
Phone  9495311820  
Fax    
Email  shahulanchal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr M S Deepa 
Designation  Professor 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Dravyagunavigyan Govt Ayurveda College Trivandrum Kerala India.695001

Thiruvananthapuram
KERALA
695001
India 
Phone  9446171568  
Fax    
Email  drdeepasathi@hotmail.com  
 
Source of Monetary or Material Support  
Govt. Ayurveda College Pulimood Junction Thiruvananthapuram 695001 
 
Primary Sponsor  
Name  Dr Aswathy G 
Address  Department of Dravyagunavigyan Govt. Ayurveda college Thiruvananthapuram Kerala 695001 
Type of Sponsor  Other [[Self]] 
 
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 Aswathy G  Govt. Ayurveda college Thiruvananthapuram  Room No 1 Dravyaguna OP Department of Dravyagunavigyan Govt Ayurveda College Hospital Thiruvananthapuram KERALA
Thiruvananthapuram
KERALA 
8301025548

aswathy1998geetha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Govt. Ayurveda College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: ASMARI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Cystone tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: -2 tablet 500 mg each administered twice daily before food
2Intervention ArmDrugOther than Classical(1) Medicine Name: Gokshuradi tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: -2 tablets 500mg each administered twice daily before food
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Participants aged between 20-65 years diagnosed as Urolithiasis of irrespective of gender.
2.Calculi size in between 2mm-10mm by ultrasonography abdomen.
3.Participants who are willing to participate in the study. 
 
ExclusionCriteria 
Details  1.Participants with Chronic kidney disease, hydronephrosis(Grade 3 & 4), Gout, other Kidney disorders.
2.Known case of malignacy.
3.Pregnant and lactating women. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Size of calculi in USG (2mm-10mm)  Baseline and 91st day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Urine investigations - deposits,pus cells,RBC in urine
2.Blood test- Renal function test(Serum uria and serum creatine).
3.Changes in symptom assessment scoring include pain,burning micturition,dysuria,tenderness in renal angle. 
Baseline,31st,61st and 91st days 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   17/03/2025 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  On personal contact via google drive

  6. For how long will this data be available start date provided 17-03-2025 and end date provided 30-11-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Urolithiasis is the formation of urinary calculi anywhere in the urinary tract. Urinary calculi are clinically characterized by colicky pain, known as renal colic, as they pass through the ureter, often accompanied by the presence of blood in the urine, known as hematuria. It can affect individuals of all ages, sexes, but it is more commonly observed in men than in women in a ratio 2:1. Conservative management of contemporary medical system includes, the dissolution of calculi often involves the administration of oral alkalinizing agents such as sodium or potassium bicarbonate, as well as potassium citrate, particularly for uric acid and cysteine calculi. Currently, surgical treatment options include extracorporeal shock wave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS) and laparoscopic ureterolithotomy. Open surgery procedures for kidney stones are also available. But these surgeries also has its complications like pain, perforation of the ureters, retained or forgotten ureteral stent, sepsis and also the cost of this surgeries are high. In ayurveda, urolithiasis can be correlated as Asmari.  Gokshuradi tablet is selected for finding its action on reducing the size of renal calculi and other signs and symptoms. The constituents of the formulation are fruit of Tribulus terrestris Linn (Gokshura), whole plant of Dendrophthoe falcata (Linn.f.) Etting (Vrukshadani), rhizome of Berginia ligulata Wall (Pashanabheda), bark of Crataeva nurvala Buch-Ham. (Varuna), and aerial part of  Hordeum vulgare Linn (Yavakshara). In Ayurveda people usually opt more easier form of drug administration. The medication in tablet form ensures a consistent dose, that is easy to consume. Gokshuradi tablet is a less scientifically observed formulation in Urolithiasis. Moreover, all the drugs in Gokshuradi tablet have proven its lithotryptic and diuretic action preclinically. Hence, the present study is indented to determine the efficacy of Gokshuradi tablet compared to Cystone tablet given twice daily in Urolithiasis as Randomized Controlled Trial.

 
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