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CTRI Number  CTRI/2023/09/058154 [Registered on: 29/09/2023] Trial Registered Prospectively
Last Modified On: 20/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Adjuvant Effect of Triphala Darvyadi Ghan Vati in Diabetic Nephropathy. 
Scientific Title of Study   Randomised Standard control clinical trial to evaluate an adjuvant effect of Triphala Darvyadi Ghan Vati in Madhumeha Upadrava with special referance to Diabetic Nephropathy. 
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 Pratiksha Dundappa Talawar 
Designation  Professor & HOD 
Affiliation  Dr.J.J.Magdum Ayurved Medical College Jaysingpur 
Address  Dr.J.J.Magdum Ayurved Medical College Shirolwadi road Agarbhag Jaysingur 416101
PDEAs College of Ayurved and Reaserch Centre Sector No 25 Pradhikaran Nigdi Pune
Pune
MAHARASHTRA
411101
India 
Phone  8975166148  
Fax    
Email  dr.pratiksha2009@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Medha Mahesh Joshi 
Designation  Professor & HOD 
Affiliation  PDEAs College of Ayurved and Reaserch Centre Nigdi Pune 
Address  PDEAs College of Ayurved and Reaserch Centre Sector No 25 Pradhikaran Nigdi Pune

Pune
MAHARASHTRA
411044
India 
Phone  9881465798  
Fax    
Email  medhamaheshjoshi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pratiksha Dundappa Talawar 
Designation  Professor & HOD 
Affiliation  Dr.J.J.Magdum Ayurved Medical College Jaysingpur 
Address  Dr.J.J.Magdum Ayurved Medical College Shirolwadi road Agarbhag Jaysingur 416101

Kolhapur
MAHARASHTRA
416101
India 
Phone  8975166148  
Fax    
Email  dr.pratiksha2009@gmail.com  
 
Source of Monetary or Material Support  
Dr.J.J.Magdum Ayurved Medical College Jaysingpur 
 
Primary Sponsor  
Name  Dr. Pratiksha Dundappa Talawar 
Address  Dr. J.J.Magdum Ayurved Medical College, Shirolwadi road agarbhag Jaysingpur 416101 
Type of Sponsor  Other [(Self)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pratiksha Dundappa Talawar  Dr.J.J.Magdum Ayurved Medical College   Kayachikitsa OPD & IPD of hospital Dr.J.J.Magdum Ayurved Medical College shirolwadi road agarbhag Jaysingpur 416101
Kolhapur
MAHARASHTRA 		 8975166148

dr.pratiksha2009@gmail.com 
Dr Pratiksha Dundappa Talawar  PDEAs Ayurved Rugnalaya and Sterling Multispeciality Hospital  Kayachikitsa OPD ground floor & IPD 1st Floor PDEAs Ayurved Rugnalaya and Sterling Multispeciality Hospital, Nigdi Pune
Pune
MAHARASHTRA 		 8975166148

dr.pratiksha2009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC of CARC  Approved 
IEC of JJMAMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E112||Type 2 diabetes mellitus with kidney complications. Ayurveda Condition: PRAMEHA-UPADRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Triphala Darvyadi Ghana Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: - Water), Additional Information: -
2Comparator Arm (Non Ayurveda)-Standard of careAnti Dibetic Drug - Metformin 500mg 1BD, Glimipride 1-6mg OD, Pioglitazone 15-30mg 1BD, Voglibose 0.2-0.6 OD Drugs for Renal Complications- N-Acetyl Cystine 600mg, Azeldipine, ACE inhibitors.
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Signs & symptoms of Madhumeha (According to Charakacharya).
2. Signs & Symptoms of Madhumeha Upadrava related to Diabetic Nephropathy.
3. Known case of Non-Insulin Dependent Diabetes Mellitus (Type 2 DM).
4. Patients having HbA1c up to 12.
6. Patients with fasting blood sugar upto 250 mg/dl & postprandial blood sugar upto 350 mg/dl.
5. Patients taking oral hypoglycemic agents since 6 months.
6. Patients having Serum Creatinine level normal to 2.5 mg/dl.
 
 
ExclusionCriteria 
Details  1. Patients with acute complications like hypoglycemic coma, ketoacidosis and related complications, history of complications, infections like gangrene.
2. Patients with known chronic diabetic complications such as end stage renal disease, patients receiving dialysis, cardiac complications, neuropathy.
3. Pregnant and lactating women.
4. Patients suffering from all major systemic diseases, IHD, TB, HIV, Carcinoma, uncontrolled HTN. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluate the Effect of Triphala Darvyadi Ghan Vati as an Adjuvant with Standard of Care in Diabetic Nephropathy through RFT GFR, Urine Routine & Microscopic, ACR Ratio  1st, 45th, 90th Day 
 
Secondary Outcome  
Outcome  TimePoints 
Observe the Effect of Triphala Darvyadi Ghan Vati in BSL & HbA1c  1st, 45th, 90th Day 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   03/10/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

According to epidemiological studies, there is increasing number of Diabetic complications. The prevalence of overt Diabetic Nephropathy is 2.2% in urban Asian Indians. Madhumeha compared to Diabetes Mellitus because of having similarities of disease respect to clinical features & etiopathogenesis. Acharya had keen observation which gave the base to Madhumeha Upadravas mentioned in ayurvedic text which can be corelated modern concept of complications of Diabetes Mellitus. Diabetic Nephropathy is leading cause of chronic kidney disease, being responsible for 30-40% of all End Stage Renal Disease cases.

So, there is need of Ayurvedic Medicine to prevent & to reduce the progression of the complications of Diabetes like Nephropathy. To establish Ayuevedic kalpas, in the Diabetic Nephropathy this study is undertaken i.e. Randomized controlled clinical trial to evaluate adjuvant effect of Triphala Darvyadi Ghana vati in Madhumeha updravas with special reference to Diabetic Nephropathy. The present study is carried out to study the efficacy of ayurvedic herbel compound Triphala Darvyadi Ghan Vati with application of modern parameters which are –

Objective Parameters - RFT, ACR ratio, GFR, HbA1c, BSL, Urine Routine.

Subjective Parameters – Avilamutrata, Naktamutrata, Pipasavrudhi, Padshotha, Dourbalya, Akshikuta shotha.

There are 2 groups in study. Triphala Darvyadi Ghan Vati with Standard of care to trial group and only Standard of care to Control group for 3 months duration. Follow up – 1st, 45th, 90th Day. Conclusion will be drawn on the basis of stastical analysis at the final stage of study.

 
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