An Open Randomized Controlled Clinical Trial to Evaluate the Efficacy of Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti in Prameha with special reference to Type 2 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Tejas Modhale
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- To find out the effect of Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti on HbA1c
Overview
Brief Summary
The present study is an open randomized controlled clinical trial designed to evaluate the efficacy of Vidangadi Lauha alone and in combination with Vastyamayantaka Ghrita Matra Basti in Prameha (Type 2 Diabetes Mellitus). A total of 99 patients equally divided into three groups
Group A Metformin
Group B Metformin and Vidangadi Lauha
Group C Metformin and Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti
Each treatment will continue for 3 months, Basti will be given for 11 days in each month for 3 consecutive months, with follow-up at 0th, 30th, 60th, and 90th day. Assessment will be based on HbA1c, eGFR, lipid profile, microalbumin-creatinine ratio, and clinical symptoms. The study aims to assess changes in HbA1c, eGFR, and microalbumin-creatinine ratio to determine whether the Ayurvedic regimen offers superior glycemic and renal outcomes compared to Metformin alone.
Primary Hypothesis
Null Hypothesis H0 Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti are not more effective than Metformin in the management of Type 2 Diabetes Mellitus.
Alternate Hypothesis H1 Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti are more effective than Metformin in the management of Type 2 Diabetes Mellitus.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Fasting blood sugar more than 126 mg/dl and less than or equal to 250 mg/dl Postprandial blood sugar more than 140 mg/dl and less than or equal to 350 mg/dl HbA1c between 6.5 to 9.5 percentage Presence of 1 or more classical symptom of Prameha.
Exclusion Criteria
- •Type 1 Diabetes Mellitus or Gestational Diabetes Patients on insulin or steroid therapy History of ketoacidosis, diabetic coma, or severe infections Major systemic illnesses Immunocompromised patients or those on immunosuppressants Severe hypertension i.e more than 180/100 mmHg.
Outcomes
Primary Outcomes
To find out the effect of Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti on HbA1c
Time Frame: Assessment on 0th 30th 60th 90th day.
To assess the symptomatic relief .
Time Frame: Assessment on 0th 30th 60th 90th day.
Secondary Outcomes
- To evaluate the efficacy of Vidangadi Lauha and Vastyamayantaka Ghrita Matra Basti on Diabetic Nephropathy parameters eGFR, microalbumin-creatinine ratio, serum electrolytes.(Assessment on 0th 30th 60th 90th day.)
Investigators
Dr Tejas Modhale
Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College.