| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other 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 | | 2 | Intervention Arm | Drug | Other 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
- 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).
- 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
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - On personal contact via google drive
- 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.
- 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. |