| CTRI Number |
CTRI/2024/02/062275 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic treatment for Chronic Kidney Disease |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Shatvaryadi ghan vati and Veertharvadi gan kwath in the management of Mutraghat w.s.r Chronic kidney disease |
| 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 Preeti Rathore |
| Designation |
PG Scholar |
| Affiliation |
Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal MP |
| Address |
PG Department of kayachikitsa Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8839202045 |
| Fax |
|
| Email |
preetirathore5407@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shwetal Shivhare |
| Designation |
Associate Professor |
| Affiliation |
Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal MP |
| Address |
PG Department of kayachikitsa Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9907898097 |
| Fax |
|
| Email |
go111280@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Rathor |
| Designation |
PG Scholar |
| Affiliation |
Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal MP |
| Address |
PG Department of kayachikitsa Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8839202045 |
| Fax |
|
| Email |
preetirathore5407@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute
Bhopal MP
|
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
PG Department of Kayachikitsa Pt. Khushilal Sharma Government
(Autonomous) Ayurveda College and Institute, Bhopal (MP) |
| Type of Sponsor |
Government funding agency |
|
|
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 Preeti Rathore |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute |
PG
Department of
Kayachikitsa
Pt. Khushilal
Sharma
Government
(Autonomous)
Ayurveda
College and
Institute
Bhopal
MADHYA
PRADESH
Bhopal
MADHYA PRADESH |
8839202045
preetirathore5407@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Pt Khushilal Sharma Government Ayurveda College Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N182||Chronic kidney disease, stage 2 (mild). Ayurveda Condition: MUTRAGHATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shatavardi ghan vati, Reference: yogratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -(2) Medicine Name: Veetharavadi gan kwath, Reference: sushrut sutra sthana 37, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Furosemide | furosemide As
directed by modern
physician
|
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Serum creatinine level grade 2.
GFR 2nd stage
HB concentration above 7gm |
|
| ExclusionCriteria |
| Details |
Serum creatinine level more than 3mg per dl.
GFR value below 60 percent.
Hb below 7gm per dl. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Serum Creatinine level
GFR
Urine output |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
creatinine level
before & after the study |
60Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/03/2024 |
| 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="0"
Months="6"
Days="15" |
|
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
|
To evaluate the efficacy of Shatvaryadi ghan vati and Veertharvadi gan kwath in the management of Mutraghat w.s.r Chronic kidney disease |