| CTRI Number |
CTRI/2024/10/074904 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know the effect of Eladi yoga kwatha in the treatment of Kidney stone |
|
Scientific Title of Study
|
Efficacy of Eladi yoga kwatha in the management of Renal calculi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Udayashree M |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurveda College Thiruvananthapuram Kerala |
| Address |
Department of Salyatantra
Govt Ayurveda College
MG Road Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9207748089 |
| Fax |
|
| Email |
udayaridhan06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aneesh S |
| Designation |
Associate Professor |
| Affiliation |
Govt Ayurveda College Thiruvananthapuram Kerala |
| Address |
Department of Salyatantra
Govt Ayurveda College
MG Road Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
8281097953 |
| Fax |
|
| Email |
draneeshkerala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aneesh S |
| Designation |
Associate Professor |
| Affiliation |
Govt Ayurveda College Thiruvananthapuram Kerala |
| Address |
Department of Salyatantra
Govt Ayurveda College
MG Road Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
8281097953 |
| Fax |
|
| Email |
draneeshkerala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College MG Road Thiruvananthapuram
Kerala India
PIN 695001 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College |
| Address |
Government Ayurveda College MG Road Thiruvananthapuram
695001 Kerala India |
| Type of Sponsor |
Other [Government Ayurveda College] |
|
|
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 Udayashree M |
Government Ayurveda college Thiruvananthapuram |
Department of Salyatantra OP division room no 3 MG Road
Thiruvananthapuram Kerala 695001
Thiruvananthapuram
KERALA |
9207748089
udayaridhan06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt Ayurveda College TVM |
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: Eladi yoga kwatha, Reference: Haritha Samhitha Asmari chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Shilajathu and Eranda thailam), Additional Information: 48 ml kashayam each is to be taken twice daily before food on adding 1.5g Shilajathu and 6ml of Eranda thailam to it |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants with Renal calculi confirmed by USG
Size of the calculi is within 4-10mm
Participants of age group 30-60 years |
|
| ExclusionCriteria |
| Details |
Participants with impaired renal functions
Diagnosed cases of malignancy
Pregnant and lactating mothers
Subjects with the diagnosed case of Hydronephrosis and any kind of suspicious echogenicity in USG |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing the size of Renal calculi |
Assessment of the size of the Renal calculi by USG will be done on 0th and 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
Final Enrollment numbers achieved (Total)= "27"
Final Enrollment numbers achieved (India)="27" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The above study deals with assessing the efficacy of Eladi yoga kwatha in Renal calculi.The kwatha along with the anupana is given in patients with Renal calculi of size 4-10mm diagnosed through USG for 30 days. Evaluation is made on reduction in size of Renal calculi through USG . |