| CTRI Number |
CTRI/2024/06/069106 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Effect of Varun Ghanvati on DJ Stent Encrustation(Tiny rocks depositing inside the tube) |
|
Scientific Title of Study
|
Randomized Clinical Trial of Varun (Crataeva nurvala Buch.-Ham.)on Urinary Stent Encrustation |
| 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 Pankaj Kumar |
| Designation |
Junior Resident |
| Affiliation |
BHU |
| Address |
Department of Shalya Tantra ,Faculty of Ayurveda ,IMS BHU ,Varanasi ,Uttar Pradesh 221005 INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9905659946 |
| Fax |
|
| Email |
pankajmuz8051349146@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof S J Gupta |
| Designation |
Professor |
| Affiliation |
IMS BHU |
| Address |
Department of Shalya Tantra ,Faculty of Ayurveda ,IMS BHU ,Varanasi ,Uttar Pradesh 221005 INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415227419 |
| Fax |
|
| Email |
sjguptabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashasvi Singh |
| Designation |
Assistant Professor |
| Affiliation |
IMS BHU |
| Address |
Department of Urology ,Faculty of Medicine ,IMS BHU ,Varanasi ,Uttar Pradesh 221005 INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09599558311 |
| Fax |
|
| Email |
yashasvisingh075@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Urology ,Sir Sundarlal Hospital ,IMS BHU |
|
|
Primary Sponsor
|
| Name |
Department of Shalya Tantra, Faculty of Ayurveda ,IMS BHU ,Varanasi |
| Address |
Varanasi, Uttar Pradesh 221005 INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Yashasvi singh |
Sir Sundarlal Hospital, BHU |
Urology OPD, OPD-16A
Varanasi
UTTAR PRADESH |
9599558311
yashasvisingh075@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,IMS BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N398||Other specified disorders of urinary system. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Varun ghan vati, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | NO DRUG | WITHOUT DRUG |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age- Between 15 to 70 years
2.Sex- Either Sex
3.Post operative renal/ureteric calculous patient with ureteric stent |
|
| ExclusionCriteria |
| Details |
1.Patients with Age below 15 years and above 70 years.
2.Malignancy
3.Patient undergoing treatment for any other serious illness.
4.HIV,HbsAg,Anti HCV-Positive |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment Criteria-
After the urinary stent is removed, it undergoes a drying process in a 60°C oven for three hours to eliminate residual urine and prevent contamination. The stent is then segmented into four sections: renal pigtail, proximal straight part, distal straight part, and bladder pigtail, with a focus on the critical ureteral junctions known for encrustation development. Encrustation volume ratios (EVR) are calculated by normalizing encrustation volume to stent volume, eliminating bias from varying sample sizes. The total encrustation volume ratio (TEVR) sums EVRs across sections to assess overall susceptibility to encrustations. The encrustation risk level (ERL) is determined by dividing EVR by TEVR to identify sections most prone to encrustation, ensuring the removal of inter-sample variability. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study the Litholytic activity of Varun ghan vati on Urinary Stent Encrustation |
2 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/07/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Urinary Stents and Catheters offer a Simple and effective drainage method for the Urinary tract. Long term use of Urinary Stents and Catheters are very frequents for therapeutic purpose of many urinary diseases and now considered a standard and indispensable urologic tool. Management of encrustation represents a continuum from therapeutic nuisance to major urologic intervention and finally it requires removal of stents and catheters and the purpose for which it was placed become defeated. As per the literature of the Ayurvedic Text that a good number of drugs have been mentioned for the treatment of Ashmari (urolithiasis) . Varuna(Crataeva nurvala) is among them and are being practiced by the concerned physician as well as surgeon since long. This drug reduces metabolic diseases like stone disease and the encrustation as both stone and encrustation have same chemical constituents. Currently there is no any clinical study available on ureteric stent encrustation however an experimental study shows positive response of effect of Varuna on ureteric stent encrustation. so there is need to research to see the clinical effect of varuna( Crataeva nurvala) on ureteric stent encrustation. All the patients who will be studied under this clinical trial after completion of treatment for prescribed period will be instructed to have regular check up at the interval of 15 days for the period of 3 months (90days) During this follow up study period patients will be examined thoroughly for the recurrence of either signs & symptoms of stones. |