| CTRI Number |
CTRI/2017/03/008118 [Registered on: 16/03/2017] Trial Registered Prospectively |
| Last Modified On: |
08/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial to study the effect of an Ayurvedic Drug Shothankusha Ras in the patients with Chronic Kidney Disease |
|
Scientific Title of Study
|
Clinical Evaluation of Shothankusha Ras in the Management of Kaphaja Shotha Vis-a-Vis Chronic Kidney Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ratna Priyadarsini Y |
| Designation |
Assistant Professor |
| Affiliation |
Dr NRS Govt Ayurvedic College Vijayawada |
| Address |
Dept of KAYA CHIKITSA
Dr NRS Govt Ayurvedic College
M G Road Vijayawada
Andhra Pradesh
India
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9440353825 |
| Fax |
08662576922 |
| Email |
dr.ratnapriyadarsini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ratna Priyadarsini Y |
| Designation |
Assistant Professor |
| Affiliation |
Dr NRS Govt Ayurvedic College Vijayawada |
| Address |
Dept of KAYA CHIKITSA
Dr NRS Govt Ayurvedic College
M G Road Vijayawada
Andhra Pradesh
India
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9440353825 |
| Fax |
08662576922 |
| Email |
dr.ratnapriyadarsini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ratna Priyadarsini Y |
| Designation |
Assistant Professor |
| Affiliation |
Dr NRS Govt Ayurvedic College Vijayawada |
| Address |
Dept of KAYA CHIKITSA
Dr NRS Govt Ayurvedic College
M G Road Vijayawada
Andhra Pradesh
India
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9440353825 |
| Fax |
08662576922 |
| Email |
dr.ratnapriyadarsini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Y.Ratna Priyadarsini,
GF-4, Gold Block,Sai Nivas Residency,Gollapudi, Vijayawada
PIN: 521225 |
|
|
Primary Sponsor
|
| Name |
Dr Ratna Priyadarsini y |
| Address |
GF4 Gold Block,Sai Nivas Residency
Near Ayyappa Temple
Gollapudi Vijayawada Rural,Krishna District
Andra Pradesh
PIN 521225 |
| 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 |
| Ratna Priyadarsini Y |
Dr NRS Govt Ayurvedic College |
Dept.of Kaya Chikitsa,
OPD, Room No :5,
Krishna
ANDHRA PRADESH |
9440353825
08662576922
dr.ratnapriyadarsini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Kidney Disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tab. Shothankusha ras |
125 mg. two times a day orally. 60 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed cases of CKD of stage I,II,III
2.Elevated Serum Creatinine levels
3.Elevated Blood urea levels
4.Chronic Glomerular Nephritis
5.Nephritic Syndrome
|
|
| ExclusionCriteria |
| Details |
1.Obstructive Causes
2.Urinary Calculi
3.Enlarged prostrate
4.Multiple Myeloma
5.Vesico Urethral Reflux
6.Clinically Non Responding Cases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms and arrest of progress of Chronic Kidney Disease with sustained reduction in abnormal kidney function tests to 50% baseline |
Relief in signs and symptoms expected in 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in abnormal Serum Creatinine levels and Blood Urea Nitrogen and Parenchymal changes in Kidney through Ultrasonography
|
Treatment for period 60 days
Assessment for every 15 days
Active follow up 3 months |
|
|
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 |
|
Date of First Enrollment (India)
|
01/05/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be Published in due coarse |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A clinical trial is done to evaluate the efficacy of the Ayurvedic preparation Shothamkusha Ras in the mangement of Kaphaja Shotha vis - a- vis Chronic Kidney Disease and to validate scientifically the observations that would significantly improve the Renal Function. Shothamkusha Ras, a unique formula of Herbo- Minerals which has its reference from an authentic Ayurvedic Classical text Bhaishjya Ratnavali and is given Orally , 125 mg, twice a day for 60 days. The study would be conducted in India aimed to complete in 4 years and the trial time being 18 months. Primary outcome measures will be relief in signs and symptoms (Subjective Parameters) number of patients with sustained reduction in abnormal Kidney function tests to 50% of baseline , arrest of the progress of the disease into ESRD and prevention of Dialysis and Renal Transplant. |