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CTRI Number  CTRI/2018/04/013063 [Registered on: 05/04/2018] Trial Registered Retrospectively
Last Modified On: 07/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study of Ayurvedic formulation in Diabetic Kidney Disease. 
Scientific Title of Study   Study of Efficacy,Safety and Tolerability of Ayurvedic Formulation in participants with Diabetic 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 Aparna Sathe 
Designation  Ph D (Scholar) 
Affiliation  R A Podar Ayurved medical college 
Address  Department Of Kayachikitsa Dr G D Pol Foundations Y M T Auyrvedic Medical College,Institutional area, Sec 4,Kharghar,Navi Mumbai.
Anne Besant Road, Worli, Mumbai 400018
Mumbai
MAHARASHTRA
410210
India 
Phone  9819216230  
Fax  02224936881  
Email  vdaparnasathe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aparna Sathe  
Designation  Ph D (Scholar) 
Affiliation  R A Podar Ayurved medical college 
Address  Department Of Kayachikitsa, Dr G D Pol Foundations Y M T Auyrvedic Medical College , Sec 4 Kharghar,Navi Mumbai
Anne Besant Road, Worli, Mumbai 400018
Mumbai
MAHARASHTRA
400705
India 
Phone  9819216230  
Fax  02224936881  
Email  vdaparnasathe@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K R Kohli 
Designation  Director of Ayurveda 
Affiliation  R A Podar Ayurved medical college 
Address  Directorate of AYUSH ,Maharashtra State, St George Dental College Bldg,Fort, Mumbai.
Anne Besant Road, Worli, Mumbai 400018
Mumbai
MAHARASHTRA
400001
India 
Phone  9869329777  
Fax  02224936881  
Email  krkohli@rediffmail.com  
 
Source of Monetary or Material Support  
R A Podar Ayurved Medical College , Worli, Mumbai400018  
 
Primary Sponsor  
Name  Dr Aparna Sathe 
Address  A/401, Omsaidham CHS Sec 17, Vashi Navi Mumbai 400705 
Type of Sponsor  Other [Ph d (Scholar) ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Aparna Sathe  R A Podar Medical College and Hospital  20, Diabetic Project OPD , OPD NO 20,Ground Floor, Hospital Building, Opposite R M O OFfice,M A Podar Ayurved Hospital ,Anne Besant road, Worli, Mumbai 400018
Mumbai
MAHARASHTRA 
9819216230
02224936881
vdaparnasathe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC-!) Seth G S Medical college and KEM hospital  Approved 
institutional ethics committee, R A podar Medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  k/c/o/ Diabetic Kidney Disease. 3months k/c/o Type 2 DM at least since 6 months., (1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, (2) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral administration of AYurvedic Formulation  Brihatyadi Kashay Ghana in a dose of 4 mg twice daily before food for study duration of 6 months Ingredients 1)Bruhati Solanum Indicum Linn 2)Kantakari Solanum Xanthocarpum Schrad and Wendl 3)Kutaj (Indrayava) Holarrhena Antidysentrica Wall 4)Patha Cissampelos Pariera Linn 5)Yastimadhu Glycyrrhiza Glabra Linn 6)Gokshur Tribulus Terrestris Linn  
Comparator Agent  Standard Conventional Treatment  Statin, Antihypertensive, RAS blocker Tab Atorvastatin 10 mg once daily Tab Enalapril Maleate 2.5-5 mg once daily for study duration of 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Adult (>18 yrs) either gender with prior diagnosis of DKD.

2. Known case of Type 2 DM diagnosed at least since 6 months.

3. CKD stage 3
3 a : e GFR (EPI) 45 to < 60
3 b : e GFR (EPI) 30 to < 45
4. Participants on stable and acceptable dose of ACE inhibitors or ARB (angiotensin II receptor blockers)
 
 
ExclusionCriteria 
Details  1)Type I DM

2)Lack of clinical evidence or suspicion of renal diagnosis other than DKD

3)UACR > 5000mg/g on any major measurement during screening.

4)Uncontrolled Diabetes (HB1Ac > 8%)

5)ESRD receiving dialysis or Anticipated progression to ESRD within treatmentperiod.

6)Status postrenal transplant.

7)Unstable CVD

8)Other concomitant disease that could impair patients safety or ability to participate in study.

9)Known case of Immunocompromised patients or subjects on immunorupressive drugs.

10)Pregnant and lactating females.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
!) Participants showing relief from clinical sign and symptoms.

2)Decrease in ACR
3)Increase in EGFREPI
 
Follow up at Every 30days 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in ACR
Increase in EGFREPI
 
At interval of 3 months
 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
Final Enrollment numbers achieved (Total)= "99"
Final Enrollment numbers achieved (India)="99" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   09/06/2017 
Date of Study Completion (India) 02/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Diabetic kidney disease is an important health hazard with increasing no of cases. Management of established diabetic kidney disease according to conventional science demands for effort to achieve good glycaemic control and a normal blood pressure and to correct any other risk factors for CVD. There is no targeted therapy for nephroprotection , only serious threats are been taken care of. The present study is undertaken to trace the genesis of diabetic kidney disease and eventually enable to study the effect of specific nephroprotective drug mentioned in Ayurvedic literature in slowing progression of the disease or to protect or even revert the disease process. The aim of the study was to study the safety, efficacy and tolerability of Bruhatyadi Kashay Ghana â€“ a polyherbal formulation in management of diabetic kidney disease. Clinical study was carried out at OPD department of both study centers. Institutional Ethics Committee approval was obtained from both IEC. Single blind randomized placebo-controlled phase 3 clinical trial was executed with sample size of 90 participants duly calculated by statistician. Specifications regarding Diagnostic criteria, Inclusion and Exclusion criteria were defined. CKD stage 3a and 3b were targeted in present study.  Standard care included oral hypoglycemic agents, antihypertensive drugs (ACE inhibitors/ARB blockers) and antilipid molecule.  Microcrystalline cellulose was used as placebo. The study drug, Bruhatyadi Kashay Ghana was prepared strictly observing principles mentioned in classics. Study drug was administered in dose of 4 gm / day as human dose in two divided doses before food. Contemplating the progressive nature of the disease, review of time span on its progression, feasibility in terms of retaining participants under clinical trial, the actual medication duration of six months was decided for this study with follow up at every month. Specially designed case record form was maintained for record keeping. ACR, eGFR (according to EPI equation), Serum Creatinine, Blood Sugar Fasting and Post Lunch, HbA1c, Urine Routine and Microscopic, Lipid Profile, Serum Electrolyte were the objective parameters assessed in this study at baseline, after 90 days and at end of the study (180 days). Symptoms were graded on the 4-grade scale (0-III) and were assessed at each follow-up. Total 99 participants were enrolled in the study after strictly observing diagnostic parameter and inclusion and exclusion criteria within approximately period of 3 years. 90 participants completed study whereas 9 dropped out. Randomization schedule provided by the statistician was considered for allocation of participants in two groups. Observed findings were subjected to suitable statistical techniques and results were interpreted. Conclusion was drawn on basis of obtained results.


 
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