| CTRI Number |
CTRI/2022/04/041954 [Registered on: 19/04/2022] Trial Registered Prospectively |
| Last Modified On: |
11/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of chronic renal failure |
|
Scientific Title of Study
|
A clinical study to evaluate the effectiveness of Sarvtobhadra vati in the patients of stage I, II and III of chronic renal failure. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dipaliben P Thakor |
| Designation |
PG Scholar |
| Affiliation |
J S Ayurveda Mahavidhyalaya |
| Address |
J S Ayurveda Mahavidhyalaya, College road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
7203085568 |
| Fax |
|
| Email |
diputhakor001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Manish V Patel |
| Designation |
Head of department |
| Affiliation |
J S Ayurveda Mahavidhyalaya |
| Address |
J S Ayurveda Mahavidhyalaya, College road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Manish V Patel |
| Designation |
Head of department |
| Affiliation |
J S Ayurveda Mahavidhyalaya |
| Address |
J S Ayurveda Mahavidhyalaya, college rod, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sundar ayurveda pharmacy of J S Ayurveda Mahavidhyalaya Nadiad |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidhyalaya |
| Address |
J S Ayurveda Mahavidhyalaya, College road, Nadiad
|
| 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 Dipaliuben P Thakor |
P D Patel Ayurveda Hospital |
P D Patel Ayurveda hospital, Department of Kayachikitsa and Panchakarma ,J S Ayurveda Mahavidhyalaya, college road, Nadiad
Kheda
GUJARAT |
7203085568
diputhokor001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarvatobhadra Vati, Reference: Bhaishajya Ratnavali Vrukkadosha Adhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Jala), Additional Information: -Modified |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of stage I, II or III of chronic renal failure (eGFR not less than 30 ml/min/1.73m2).
2. Patients having age between 18 to 65 years of both genders will be included for the study.
3. Serum creatinine less than3.0 mg/dl.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are on dialysis treatment. Patients who are already operated for renal transplantation and then having nephropathy.
2. Patients of hepato-renal insufficiency or renal insufficiency due to haemodynemic circulatory disorders and CCF.
3. Patients with some serious illness like cardio-vascular diseases, psychological disorders, serious acute organic diseases, serious chronic co-morbidities, liver disorders or metabolic disorders etc
4. Female patients having pregnancy, breast feeding or post-delivery period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome will be relief in sign and symptoms, laboratory investigations like Hb, eGFR, Serum Creatinine, Blood Urea, Serum Electrolytes (sodium, potassium, chloride,),Serum Calcium and Urine Analysis.
|
Baseline and after 3 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/05/2022 |
| Date of Study Completion (India) |
11/09/2023 |
| 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
Modification(s)
|
this research work will be published in peer rewviwed journal after geting premission from concern authority of the institue. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Clinical evaluation of Ayurvedic management in Chronic kidney Disease ( stage I II III) is the main object of the study. Patients were selected from O.P.D of P.D.Patel Ayurvedic Hospital, Nadiad after the conformation of the Patients of the CKD. patients were selected with the help of classical signs and symptoms and they were treated with the following therapy. 1) Sarvatobhadra vati - 2 tablet (each 250mg) twice a day.
|