| CTRI Number |
CTRI/2024/04/065576 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
clinical study on poly herbal combination on diabetic kidney disease |
|
Scientific Title of Study
|
An open controlled clinical study to evaluate efficacy of Sariwadi Yoga in early
diabetic kidney disease with special reference to microalbuminurea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arati Datye |
| Designation |
Assistant professor and PhD student |
| Affiliation |
R A PODAR medical college (Ayu) Worli Mumbai 18 |
| Address |
Room no 19 Department of Kayachikitsa, R A Podar medical college (Ayu), DR Anne Besant road, Worli Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
07758977066 |
| Fax |
|
| Email |
aratidatye@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arati Datye |
| Designation |
Assistant professor and PhD student |
| Affiliation |
R A PODAR medical college (Ayu) Worli Mumbai 18 |
| Address |
Room no 19 Department of Kayachikitsa, R A Podar medical college (Ayu), DR Anne Besant road, Worli Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
07758977066 |
| Fax |
|
| Email |
aratidatye@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arati Datye |
| Designation |
Assistant professor and PhD student |
| Affiliation |
R A PODAR medical college (Ayu) Worli Mumbai 18 |
| Address |
Room no 19 Department of Kayachikitsa, R A Podar medical college (Ayu), DR Anne Besant road, Worli Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
07758977066 |
| Fax |
|
| Email |
aratidatye@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicale] |
|
|
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 Arati datye |
R A POdar medical college AYU |
OPD no.18 /19 OPD OF KAYACHIKITSA, M A PODAR HOSPITAL AND R A Podar Medical College (AYU)
Dr.Anne Besant Road Worli Mumbai 400018
Mumbai
MAHARASHTRA |
07758977066
aratidatye@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee,R A Podar medical college (Ayu) Worli, Mumbai 18 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N181||Chronic kidney disease, stage 1. Ayurveda Condition: PRAMEHA-UPADRAVAH, (2) ICD-10 Condition:N182||Chronic kidney disease, stage 2 (mild). Ayurveda Condition: PRAMEHA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | crystalline methyl cellulose | it is an inert material not absorbed from gut and hence do not xert any additionla effct hence used as placebo | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Saariwaadi Yoga , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -(2) Medicine Name: Sariwaadi Yoga, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: Sariwaadi Yoga contains Sariwa,Triphala,guduchee,Punarnava, Gokshur,Varun, Arjun |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
k/c/o type 2 DM atleast since 6 monthd
protienurea in the range 30-300 mcg/dl
eGFR more than 45 ml/hr
sr creatinineless than 2 mg/dl |
|
| ExclusionCriteria |
| Details |
uncontrolled DM and HTN
renal diorders causing protienurea
pregnancy and lactation
mallignancy
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in 24 hr urine microalbumin
reduction in albumin creatinine ratio
improvement in eGFR |
Reduction in 24 hr urine microalbumin
reduction in albumin creatinine ratio
improvement in eGFR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in symptoms like fatigue, edema |
at the end of three months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/04/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [draratijoglekar@gmail.com].
- For how long will this data be available start date provided 05-12-2028 and end date provided 05-12-2035?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Valid informed written consent will be taken in the language best understood by the patient PLAN OF ACTION : Screening and selection of the patients will be carried out as per inclusion and exclusion criteria. -> Screening for selection criteria Included for Study Written Informed consent Randomization (Statistician provided random allocation) into 2 groups Group A = Study Group ,Group B =, Placebo group Follow up every 30 days with Close observation of symptoms and AE if any Completion after 3 months Statistical analysis with Appropriate test and Interpretation of Result Treatment schedule : group A : standard care (OHA/Insulin, Statin, Anti hypertensive, RAS blockers)+ Saariwadi yoga Group B : standard care + placebo drug (OHA/Insulin, Statin Anti hypertensive, RAS blockers Explanation for Insulin therapy in standard care Trial Drug: Sariwadi Yoga 4 gm per day control drug crystallline methyi cellulose Drug will be dispenced to the patients for the period of three months free of cost patients will be evaluated clinically every week and laboratorical investigations will be done before screening an at the end of 3 monthsafter completion of study parametric data ( 24 hr urine micro albuminurea urine/creatinine ratio/sr creatinine ) will be analysed within the group and between the groups with students T test . and then conclusion will be drawn considering p value.p |