| 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
|
|
|
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
|
|
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 – 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. |