| CTRI Number |
CTRI/2025/04/085342 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| 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
|
MANAGEMENT OF ASHMARI (W.S.R. TO UROLITHIASIS) BY SWADRAMSTADI KWATH AND VARUNADI KSHAY |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF VARUNADI KSHAAY AND SWADRAMSTADI KWATH IN THE MANAGEMENT OF ASHMARI W.S.R. TO UROLITHIASIS |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AYUSH UPADHAYAYA |
| Designation |
PG SCHOLAR |
| Affiliation |
RANI DULLAIYA AYURVED PG COLLEGE AND HOSPITAL |
| Address |
PG Department of shalya tantra opd no. 07 RANI DULLAIYA SMRITI AYURVED PG COLLEGE BHOPAL MP
RANI DULLAIYA SMRITI AYURVED PG COLLEGE BHOPAL MP
Bhopal
MADHYA PRADESH
462004
India |
| Phone |
6263785334 |
| Fax |
|
| Email |
ayush270595@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
shraddha sakhare |
| Designation |
HOD & professor in shalya department |
| Affiliation |
ANI DULLAIYA AYURVED PG COLLEGE AND HOSPITAL |
| Address |
PG Department of shalya tantra opd no. 07 RANI DULLAIYA SMRITI AYURVED PG COLLEGE BHOPAL
RANI DULLAIYA SMRITI AYURVED PG COLLEGE BHOPAL MP
Bhopal
MADHYA PRADESH
462004
India |
| Phone |
8208586302 |
| Fax |
|
| Email |
sakhare2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
shraddha sakhare |
| Designation |
HOD & professor in shalya department |
| Affiliation |
ANI DULLAIYA AYURVED PG COLLEGE AND HOSPITAL |
| Address |
PG Department of shalya tantra opd no. 07 RANI DULLAIYA SMRITI AYURVED PG COLLEGE BHOPAL
RANI DULLAIYA SMRITI AYURVED PG COLLEGE BHOPAL MP
Bhopal
MADHYA PRADESH
462004
India |
| Phone |
8208586302 |
| Fax |
|
| Email |
sakhare2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| RANI DULLAIYA SMRITI AYURVED PG COLLEGE 462044 BHOPAL MP INDIA |
|
|
Primary Sponsor
|
| Name |
DR AYUSH UPADHAYAYA |
| Address |
PG SCHOLAR SHALYA TANTRA DEPARTMENT RANI DULLAIYA SMRITI AYURVED PG COLLEGE 462044 BHOPAL MP |
| 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 Ayush Upadhyaya |
Rani Dullaiya Smriti Ayurved Hospital Bhopal |
P.G. Department of shalya tantra ,o.p.d no.7 , Rani Dullaiya Smriti Ayurved PG Evam Chikitsalaya,Barkhedi Kalan,Bhopal, M.P.
Bhopal
MADHYA PRADESH |
6263785334
Ayush270595@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Rani dullaiya smriti ayurved pg college and hospital bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N202||Calculus of kidney with calculus of ureter. Ayurveda Condition: ASADHYA-ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: VARUNADI KSHAAY, Reference: CHAKRADUTT, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: VARUNADI KSHAAY, Reference: CHAKRADUTT, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SWADRAMSTADI KWAATH, Reference: CHAKRADUTTA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Day(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Ashmari as described In Ayurveda classics and
modern literature. |
|
| ExclusionCriteria |
| Details |
Patients not fulfilling the inclusion criteria.
Patients below 16 years and above 60 years
Patients suffering from systemic diseases viz. Diabetes mellitus, Hypertension,
Hypothyroidism, Carcinoma etc. and Infectious Disease Viz. Tuberculosis, HIV
etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduce pain in the groin and flanks. |
4WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relieve in the pain, bleeding , inflammation, hydronephrosis |
28 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/05/2025 |
| 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
|
this is a double group open label comparitive clinical study of varunadi kshaay and swadramstadi kwath in the management of urolithiasis W.R.S ashmari . The primary outcome is to reduce pain in the flanks and groins region with relief in associated features will be measured by subjective and objective parameters swadramstadi and varunadi kshaaye will be effective in tmanaging the condition caused due to ashmari. |