Diabic Care Juice in Type 2 Diabetic Patients

A Randomized, Open labelled, Active-controlled, Prospective Clinical Study to Evaluate Efficacy and Safety of Diabic Care Juice in Type 2 Diabetic Patients - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/063389

Enrollment

Registered

2024-02-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Type II DM patients

Exclusion criteria

Exclusion criteria: 1. Patients on insulin therapy 2. Patients suffering from Type-1 DM or Type of Diabetes mellitus other than Type-2 3. Patients with known history of major complications of Diabetes like Keto-acidosis, Nephropathy, Neuropathy, Retinopathy and Diabetic wounds 4. Patients with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C or HIV 5. Patients with known history of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes 6. Patients with known history of chronic hepatic or renal disease 7. Patients with known history of active malignancy 8. Patients with known history of significant cardiovascular event at least 12 weeks prior to randomization. 9. Known history of hypersensitivity to ingredients used in study drug 10. Pregnant and Lactating females 11. Any other conditions which in the opinion of investigator can place the patient at risk or can have influenced the conduct of study or interpretation of results

Design outcomes

Primary

Measure	Time frame
Changes in HbA1C% (Glycosylated Haemoglobin) (from baseline to 90 days) 2.Monthly changes in WHO-QOL-BREF over three months of the study period Timepoint: Day 0, Day 90	—

Secondary

Measure	Time frame
1. Changes in fasting and post-4prandial BSL between the groups over three months of study period (on every follow up visit) 2. Changes in HOMA-IR score between the two groups from baseline to 90 days 3. Changes in clinical symptoms of Type 2 DM on every follow up visit 4. Assessment of tolerability of study drug by assessing ADRs 3. Changes in Laboratory parameters like Liver function tests (LFT) - ALT & AST, Renal function tests (RFT) - Sr. Creatinine, BUN and Sr. Uric Acid, Lipid profile, complete blood count (CBC), ESR, Urine Examination (from baseline to 90 days)Timepoint: baseline visit (day 0), visit 1 (day 15), visit 2 (day 30), visit 3 (day 45), visit 4 (day 60), visit 5 (day 75) and visit 6 (day 90)	—

Measure

Time frame

1. Changes in fasting and post-4prandial BSL between the groups over three months of study period (on every follow up visit) 2. Changes in HOMA-IR score between the two groups from baseline to 90 days 3. Changes in clinical symptoms of Type 2 DM on every follow up visit 4. Assessment of tolerability of study drug by assessing ADRs 3. Changes in Laboratory parameters like Liver function tests (LFT) - ALT & AST, Renal function tests (RFT) - Sr. Creatinine, BUN and Sr. Uric Acid, Lipid profile, complete blood count (CBC), ESR, Urine Examination (from baseline to 90 days)Timepoint: baseline visit (day 0), visit 1 (day 15), visit 2 (day 30), visit 3 (day 45), visit 4 (day 60), visit 5 (day 75) and visit 6 (day 90)

—

Countries

India

Contacts

Public ContactVedvati Bhapkar

D. Y. Patil deemed to be University School of Ayurveda, Navi Mumbai, Maharashtra

vinay.pawar@dypatil.edu7506631983

Outcome results