| CTRI Number |
CTRI/2023/10/058242 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
03/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study of two Ayurvedic drugs, Gokshuradi Guggulu and Renogrit in patients with Kidney disease |
|
Scientific Title of Study
|
A comparative clinical study of Gokshuradi Guggulu and Renogrit in 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 Ankita Aggarwal |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar Uttarakhand India |
| Address |
Department of Kayachikitsa, OPD no.13/14, Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar Uttarakhand India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7618288890 |
| Fax |
|
| Email |
ankita.ankitaaggarwal97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Nilesh Ingle |
| Designation |
Associate professor, department of kayachikitsa |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar Uttarakhand India |
| Address |
Department of Kayachikitsa, OPD no.13/14, Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar Uttarakhand India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9881165320 |
| Fax |
|
| Email |
dr.aningle2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nilesh Ingle |
| Designation |
Associate professor, department of kayachikitsa |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar Uttarakhand India |
| Address |
Department of Kayachikitsa, OPD no.13/14, Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar Uttarakhand India 249405
UTTARANCHAL
249405
India |
| Phone |
9881165320 |
| Fax |
|
| Email |
dr.aningle2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Hridwar Uttarakhand 249405 |
| Type of Sponsor |
Private medical 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 Ankita Aggarwal |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan |
Department of Kayachikitsa, OPD no. 13/14, Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar Uttarakhand India 249405
Hardwar
UTTARANCHAL |
7618288890
ankita.ankitaaggarwal97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Institutional Ethical Committee |
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: Gokshurdi Guggulu, Reference: SH.S.M.KH.7/84-87, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: water), Additional Information: | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Renogrit , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 540(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
.Clinically stable patients of stage 1, 2 as per K/DOQI guidelines
2.Creatinine level i.e., between 1.5 mg/dl to 5 mg/dl.
3.Blood urea levels between- 50 to 130 mg/dl
4.Patients of either gender between the age group of 16 to 70 years of age
|
|
| ExclusionCriteria |
| Details |
1. Associated complications like respiratory distress, Anuria, oliguria, cardiovascular complications.
2. Patients Requiring dialysis and renal transplant.
3. Patients with Malignant hypertension, Uncontrolled Diabetic patients, SLE.
4. Pregnant, lactating Women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
subejctive criteria-
1.pedal edema
2.nausea
3.anorexia
4.vomiting
5.Breathlessness
6.tiredness
|
0 day 30th day 60th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective criteria
1 Hb
2 Serum creatinine blood urea
3 Routine Microscopic examination of urine
urine protein albumin bacteria
4 eGFR
|
0 day 30th day 60th day |
|
|
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)
|
13/10/2023 |
| 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 Yet Recruiting |
| 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
|
This is an open label double arm comparative clinical study , comparing the efficacy of Gokshuradi Guggulu 500 mg 2 Tablets twice daily before meals and Renogrit tablet 540 mg each 2 tablets twice daily before meals for 18 months in 40 patients of Chronic Kidney Disease that will be conducted in OPD no. 13/14 at Patanjali Ayurveda hospital, Haridwar |