A clinical trial to evaluate the efficacy of GokshuraBrihatyadi Kashaya in the management of prameha Janya upadravas with special reference to Diabetic Nephropathy.

Phase 2

Conditions: Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

Registration Number: CTRI/2023/04/051259

Lead Sponsor: DrViraj V Shukla

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Pre diagnosed patients of Type 2 DM will be included in study.

2.Patients of both sexes of the age in between 40-70 yrs will be included in study.

3.Patients with lab values

a)Sr. Creatinine <2.5 mg/dl

b)Microalbuminuria < 30-300 mg/dl

c)BUN < 50 mg/dl will be included in study.

4.Patients of Diabetic Nephropathy up to reversible stage i.e. overt Diabetic Nephropathy.

5.Patients having symptoms as described in Ayurveda classical text as,

a)Akshikuta Shotha

b)Pada Shotha

c)Sarvang Shotha

d)Mutralpata

e)Kshudhalpata

f)Hrillas / Chhardi will be included in study.

Exclusion Criteria

1.Type 1 DM will be excluded from study.

2.Patients of Type 2 DM on insulin will be excluded from study.

3.Patients having any other serious illnesses like Tuberculosis, HIV/AIDS, Congestive Cardiac Failures, Chronic Kidney Disease, Morbidly Obese will be excluded from study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To asses whether microalbumin urea levels remains in normal range <br/ ><br>i.e.30 to 300 mg per 24 hrs At Baseline And after 8 weeks of trial drug intervention. <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: <br/ ><br>Both subjective and Objective assesment will done at baseline and after 8 weeks.

Secondary Outcome Measures

Name	Time	Method
To Study The Probable Mode Of Action Of Gokshura Brihatyadi kashaya In Diabetic Nephropathy. <br/ ><br> <br/ ><br> The Pharmacological Properties Of The Compound Drug Gokshura Brihatyadi kashaya will be Assessed as per Ayurveda principles like Rasa, Veerya, Vipak, Prabhav Through Literature In Context With Improvement In Subjective And Objective Parameters.Timepoint: Subjective and Objective Parameters Will Be Assessed At Baseline,And After 8 Weeks