| CTRI Number |
CTRI/2025/05/087260 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| 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
|
Drug trial for Ashmari |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Evaluate the Efficacy of Gokshuradi Vati in the
Management of Ashmari W.S.R. Nephrolithiasis |
| 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 Abhishek Ranjan |
| Designation |
PG Scholar ,Shalyatantra |
| Affiliation |
Sri Sai Ayurvedic PG medical college Aligarh |
| Address |
Jeevak kshatrawas
Sri sai ayurvedic PG college
Aligarh UP 202001
Department of shalya Tantra
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9990501800 |
| Fax |
|
| Email |
dr_abhishek_ranjan@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupinder |
| Designation |
Professor |
| Affiliation |
Sri Sai Ayurvedic PG Medical College Aligarh |
| Address |
Department of Shayla Tantra
Sri Sai Ayurvedic PG medical college
Aligarh , UP
Department of shalya tantra
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9996247919 |
| Fax |
|
| Email |
dr.bhupindersaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Kumar yadav |
| Designation |
Lecture |
| Affiliation |
Sri Sai Ayurvedic PG Medical College Aligarh |
| Address |
Department of shalya Tantra
Sri Sai Ayurvedic PG Medical College
Aligarh
Department of shalya tantra
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9546717067 |
| Fax |
|
| Email |
ypraveen4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri sai Ayurvedic PG medical college Aligarh Uttar Pradesh India 200201 |
|
|
Primary Sponsor
|
| Name |
Dr Abhishek ranjan |
| Address |
Pg scholar
Department of shalya Tantra
Sri sai Ayurvedic pg medical college Aligarh Uttar Pradesh India 200201
|
| Type of Sponsor |
Other [Self funding ] |
|
|
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 praveen kumar yadav |
Sri sai Ayurvedic pg medical college aligarh |
Department of shalya Tantra
Sri sai Ayurvedic pg Medical College
Aligarh Uttar Pradesh 200201
Aligarh
UTTAR PRADESH |
9546717067
ypraveen4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Sri sai Ayurvedic PG Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N200||Calculus of kidney. 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: Gokshuradi vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Grasa bhakta/Sagrasa, Duration: 60 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 18 to 70 years.
Patients having signs and symptoms of Renal Stone
Stone size up to 6-10 mm. |
|
| ExclusionCriteria |
| Details |
Renal failure
Patients with severe pain
Patient requiring immediate surgical intervention
Severe Haematuria, Stag horn calculus
Stone size more than 10 mm
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective
Pain
Urgency
Dribbling
Burning Micturition
Dysuria
Hematuria
Weak Urine Stream
Pain in Lower Abdomen |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
31/05/2025 |
| 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="6"
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 - NO
|
|
Brief Summary
|
To find out the efficacy of the trial Drugs, ‘Gokshuradi Vati’ in the management of Ashmari. To compare the efficacy of Gokshuradi vati with the Gokshuradi Guggulu in the management of renal stone .
|