| CTRI Number |
CTRI/2024/11/077263 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| 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
|
Comparative Study of the effectiveness of Gokshuradi Avleha and Shwadanshtradi Panak in the Treatment of Renal Stone |
|
Scientific Title of Study
|
A Comparative Clinical Study of Shwadanshtradi Panak & Gokshuradi Avleha in the Management of Vrikkashmari w.s.r. to Renal Stone |
| 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 Narendra Singh Shekhawat |
| Designation |
PhD Scholar |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
PG Dept of Shalya Tantra, Post Graduate Institute of Ayurved, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University,Kadwad,Nagaur Road, Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9928297691 |
| Fax |
|
| Email |
dr.naren90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar Gupta |
| Designation |
Professor & HOD Shalya Tantra |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
PG Dept of Shalya Tantra, Post Graduate Institute of Ayurved, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University,Kadwad,Nagaur Road, Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636530573 |
| Fax |
|
| Email |
guptadrrajeshkumargupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Kumar Gupta |
| Designation |
Professor & HOD Shalya Tantra |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
PG Dept of Shalya Tantra, Post Graduate Institute of Ayurved, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University,Kadwad,Nagaur Road, Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636530573 |
| Fax |
|
| Email |
guptadrrajeshkumargupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Kadwad, Nagaur Road, Jodhpur Rajasthan, India, pin code 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University |
| Address |
Kadwad, Nagaur Road, Jodhpur, Rajasthan, india pin code 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre |
Adarsh Vijendra Marg, Gangoh, Saharanpur, Uttar Pradesh,247341 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Narendra Singh Shekhawat |
Kunwar Shekhar Vijendra Ayurved Hospital and Research Centre |
Department of Shalya tantra, Room No 3, Shobhit University, Babu Vijendra Marg, Gangoh, Pin code 247341
Saharanpur
UTTAR PRADESH |
9928297691
dr.naren90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kunwar Shekhar Vijendra Ayurved College & Research Center, Shobhit University |
Approved |
| Institutional Ethics Committee, Post Graduate institute of Ayurved, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shwadanshtradi Panak, Reference: Chakradatt Ashmari Chikitsa Adhay 34/31, Route: Oral, Dosage Form: Panak/ Sharbat, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi Avleha, Reference: Vrihad Nighantu Ratnakar/PAncham Bhag/Mutrakrichhkarmavipak Adhyay page no. 752, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 48(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having primary stones, first time stone former, renal stone size from 1 to 20 mm |
|
| ExclusionCriteria |
| Details |
Patients having renal failure, gross hydronephrosis, acute pain in abdomen, cases which require surgical intervention, severe haematuria, bladder stone, ureteric stone, case of comorbidity, retention of urine, secondary stone. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective symptoms like Pain and Dysuria will be assessed
|
zero day, 10th day, 20th day and 30th day during the intervention will be assessed
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
objective symptoms like Haematuria, pus Cells & Radiological Findings will be assessed
a. Site of Stone
b. Size of Stone
c. Number of Stones
|
zero day, 10th day, 20th day & 30th day during the intervention will be assessed |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
09/12/2024 |
| 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
|
This study is randomized, parallel group, active controlled trail comparing the efficacy of Shwadanshtradi Panak and Gokshuradi Avleha for 1 year in 100 patients with vrikkaashamari wsr to renal stone. The primary outcome measures will be relief in pain and dysuria. The secondary outcome measures will be decrease in Haematuria , Pus cells and Radiological findings like size of stone and number of stone. |