Adjuvant Effect of Triphala Darvyadi Ghan Vati in Diabetic Nephropathy.

Phase 2/3

Not yet recruiting

Conditions: Type 2 diabetes mellitus with kidney complications. Ayurveda Condition: PRAMEHA-UPADRAVAH,

Registration Number: CTRI/2023/09/058154

Lead Sponsor: Dr. Pratiksha Dundappa Talawar

Brief Summary: Accordingto epidemiological studies, there is increasing number of Diabeticcomplications. The prevalence of overt Diabetic Nephropathy is 2.2% in urbanAsian Indians. Madhumeha compared to Diabetes Mellitus because of havingsimilarities of disease respect to clinical features & etiopathogenesis. Acharyahad keen observation which gave the base to Madhumeha Upadravas mentioned inayurvedic text which can be corelated modern concept of complications of DiabetesMellitus. Diabetic Nephropathy is leading cause of chronic kidney disease,being responsible for 30-40% of all End Stage Renal Disease cases.

So, there isneed of Ayurvedic Medicine to prevent & to reduce the progression of thecomplications of Diabetes like Nephropathy. To establish Ayuevedic kalpas, inthe Diabetic Nephropathy this study is undertaken i.e. Randomized controlledclinical trial to evaluate adjuvant effect of Triphala Darvyadi Ghana vati in Madhumehaupdravas with special reference to Diabetic Nephropathy. The present study iscarried out to study the efficacy of ayurvedic herbel compound TriphalaDarvyadi Ghan Vati with application of modern parameters which are â€“

ObjectiveParameters - RFT, ACR ratio, GFR, HbA1c, BSL, Urine Routine.

SubjectiveParameters â€“ Avilamutrata, Naktamutrata, Pipasavrudhi, Padshotha, Dourbalya,Akshikuta shotha.

There are 2 groupsin study. Triphala Darvyadi Ghan Vati with Standard of care to trial group andonly Standard of care to Control group for 3 months duration. Follow up â€“ 1st,45th, 90th Day. Conclusion will be drawn on the basis ofstastical analysis at the final stage of study.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Observe the Effect of Triphala Darvyadi Ghan Vati in BSL & HbA1c	1st, 45th, 90th Day

Trial Locations

Locations (2): Dr.J.J.Magdum Ayurved Medical College
🇮🇳
Kolhapur, MAHARASHTRA, India
PDEAs Ayurved Rugnalaya and Sterling Multispeciality Hospital
🇮🇳
Pune, MAHARASHTRA, India
Dr.J.J.Magdum Ayurved Medical College
🇮🇳Kolhapur, MAHARASHTRA, India
Dr Pratiksha Dundappa Talawar
Principal investigator
8975166148
dr.pratiksha2009@gmail.com