| CTRI Number |
CTRI/2021/04/033218 [Registered on: 28/04/2021] Trial Registered Prospectively |
| Last Modified On: |
09/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Punarnavadi Kwath and Varunadi Kwath In The Management Of Mutravaha Sarotodushti ( Chronic Kidney Disesase )
|
|
Scientific Title of Study
|
Randomised Comparative Clinical Trial To Evaluate The Efficacy Of Punarnavadi Kwath And Varunadi Kwath In The Management Of Mutravaha Srotodushti W.S.R. 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 Karan Prakash Sharma |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Kayachikitsa
National Institute of Ayurveda,
Jaipur
Rajasthan
302002
India
National Institute of Ayurveda, Amer Road, Madhav Vilas, Jorawar Singh Gate,
Jaipur
Rajasthan
302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
8239225104 |
| Fax |
|
| Email |
kpsayurvedh024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ram Kishor Joshi |
| Designation |
Professor and Head of Department |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Kayachikitsa
National Institute of Ayurveda,
Jaipur
Rajasthan
302002
India
National Institute of Ayurveda, Amer Road, Madhav Vilas, Jorawar Singh Gate,
Jaipur
Rajasthan
302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414322297 |
| Fax |
|
| Email |
joshirk1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karan Prakash Sharma |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Kayachikitsa
National Institute of Ayurveda,
Jaipur
Rajasthan
302002
India
National Institute of Ayurveda, Amer Road, Madhav Vilas, Jorawar Singh Gate,
Jaipur
Rajasthan
302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
8239225104 |
| Fax |
|
| Email |
kpsayurvedh024@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute Ayurveda Jaipur |
| Address |
Madhav Vilas Palace Amer Road jaipur 302002 |
| 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 Karan Prakash Sharma |
National Institute of Ayurveda and Hospital |
OPD No. 1,7,18,22,25, Madhav Vilas ,Amer Road
Jaipur
Rajasthan
302002
Jaipur
RAJASTHAN |
8239225104
kpsayurvedh024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N18||Chronic kidney disease (CKD). Ayurveda Condition: MUTRAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Punarnavadi kwatha |
Orally Given Punarnavadi kwatha 40ml twice a day before meal for 30 days. |
| Comparator Agent |
Varunadi kwatha |
Orally Given Varunadi kwatha in 40ml twice a day before meal for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient willing to participate in clinical trial
2 Patients having any clinical signs and symptoms of chronic renal failure
3 Patients with Hypertension <160/100 mm of hg
4 Patients of Serum creatinine level 1.2 to 5.0 mg/dl
5 Patients of Blood urea level 40 to 150 mg/dl
|
|
| ExclusionCriteria |
| Details |
1 Age: below 21 years and above 59 years
2 Patients having other associated disease like congenital disease Myeloma, Neoplasm etc.
3 Patient participated in any clinical trial with in last six months.
4 Pregnant or lactating women.
5 Familial or hereditary kidney disease, e.g. Polycystic kidney
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the clinical symptoms of Mutravaha Srotodushti (Chronic Kidney Disease). |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the objective parameters. |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/08/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIMS
AND OBJECTIVES:
qTo evaluate and compare the clinical
efficacy of “Punarnavadi Kwatha†and “Varunadi Kwatha†in the management of Mutravaha Srotodushti w.s.r to Chronic Kidney Disease.
NEED OF
STUDY:
qRetarding the progression of renal
failure is one of the most important task of the nephrologist as it not only
involves the quality of life of patient but also delays the development of end
stage renal diseases, use of dialysis, transplantation cause financial burden
to patient.
q Varunadi Kwatha seem to be helpful to relieve the Kapha and Vata Dosha and Punarnavadi Kwatha has Rasayan properties for Mutravaha Srotas which can prevent and repaired a tissue
damage.
q After reviewing the literature and
keeping in mind the Dosha- Dushya of Mutravaha Srotodusti, Punarnavadi Kwath and Varunadi Kwatha has been chosen for the study as these
drugs possess above mentioned properties.
HYPOTHESIS:
NULL
HYPOTHESIS:
There is no
significance difference between the effect of trial drug ( Punarnavadi
Kwath
and Varunadi Kwath
)
ALTERNATIVE
HYPOTHESIS:
There is a significant difference between the
effect of trial drugs (Punarnavadi Kwath
and Varunadi Kwatha)
in
the management
of Mutravaha Srotodushti.
STUDY
DRUGS
A.Punaranavadi
Kwath
( Kalpit
Yoga )
B.Varunadi
Kwath
( Bhavaprakasha
Chi.37/12 ) |