Randomized controlled trial of Kushtadi Churna Vati as an add-on effect in the management of Madhumeha
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To evaluate the efficacy of Kushtadi Churna Vati in Madhumeha.
Study Overview
Brief Summary
Randomized controlled trial of Kushtadi Churna Vati as an add-on effect in the management of Madhumeha. Diabetes mellitus is a long term metabolic disorder that is characterized by high blood sugar, insulin resistance and relative lack of insulin. We have developed newer medicines ,but we come across limitations of OHA, therefore there is a need for traditional need for the better management of DM. Considering all above things the study will be carried out in comparison with conventional modern treatment. Patients will be divided in two groups containing 30 each. All the drugs having Pramehaghna properties as well as having Kaphahara, vatahara, Medohara and kledashoshak properties. Thus they can be helpful in reducing the symptoms and Samprapti Vighatan of the disease.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •A known Diabetic on treatmenet and a newly diagnosed Diabetes.
- •Patient with fasting blood sugar upto 220mg% and post prandial blood sugar upto 300mg% 3.patient having HBA1C upto 10 4.Patient having fasting blood sugar in between 221 to 250 and post prandial 301 ton 350 will be included , if HBA1C is upto
- •If the patient is taking ayurvedic medicine for Madhumeha , washing period for them will be 8 days.
Exclusion Criteria
- •Patients with fasting blood sugar above 220 mg% and post prandial blood sugar above 300mg%.
- •Patient who is already taking Ayurvedic management for Madhumeha.
- •Diabetes Mellitus Type-I ,Acromegaly, Cushing’s syndrome and pancreatic disorder.
- •Those who are under Insulin therapy.
- •Pregnant and lactating mothers.
- •Patients with acute complications like Hyperglycemic coma, Ketoacidosis and infections like gangrene.
- •Patients with K/C/O Nephropathy, Neuropathy and Retinopathy.
- •Patients with gastrointestinal diseases, Liver diseases, tumors, conditions like cardiovascular disease, acute myocardial infarction, immune-compromised disease(HIV).
Outcomes
Primary Outcomes
To evaluate the efficacy of Kushtadi Churna Vati in Madhumeha.
Time Frame: 3 months
Secondary Outcomes
- 1)To evaluate the efficacy of Kushtadi Churna Vati in Madhumeha on the basis of subjective parameters.(2)To evaluate the efficacy of Kushtadi Churna vati in reducing the elevated Blood Sugar Levels in Madhumeha in fasting state.)