A Study to Check How Safe and Effective Diabetic Care Juice Is for People with Diabetes

An Open-Label, Single-Arm, Single-Center Phase 3 Study to Evaluate the Safety and Efficacy of Diabetic Care Juice in Patients with Diabetes - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085900

Enrollment

Registered

2025-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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: 1. Age and Gender: Adults aged 30 to 75 years of either gender 2. Diagnosis: A documented clinical diagnosis of diabetes according to WHO criteria with Fasting Blood Sugar (FBS) greater than 126 mg per dl and Postprandial Blood Sugar (PPBS) greater than 160 mg per dl 3. Body Mass Index (BMI): Greater than 23 kg per meter square 4. Informed Consent: Ability and willingness to provide written informed consent before any study-related procedures 5. Compliance: Willingness to comply with all study procedures including scheduled visits and treatment administration

Exclusion criteria

Exclusion criteria: 1. Prior Diabetes Treatment: History of treatment with insulin or any oral hypoglycemic agents other than metformin 2. Significant Comorbidities: Presence of major illnesses that could interfere with study outcomes such as bronchial asthma or chronic obstructive pulmonary disease COPD, blood disorders or malignancies, cardiovascular or hepatobiliary diseases 3. Metabolic and Organ Dysfunction: Presence of hyperlipidemia, severe hepatic dysfunction, renal dysfunction, uncontrolled pulmonary dysfunction, or poorly controlled hypertension 4. Concurrent Participation: Participation in another clinical trial or use of any investigational product within a specified washout period prior to screening 5. Pregnancy and Lactation: Pregnant or lactating women will be excluded 6. Inability to Consent: Unwillingness or inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
Glycemic Control: To evaluate the change in the diabetic panel from baseline to the end of study EOS as measured by Glycosylated hemoglobin HbA1c Fasting Blood Sugar FBS Postprandial Blood Sugar PPBSTimepoint: Day 0, Day 30, Day 60 and Day 90	—

Secondary

Measure	Time frame
Quality of Life: Improvement in quality of life as measured by the SF 36 health survey from baseline to Day 90Timepoint: Day 0, Day 30, Day 60 and Day 90	—

Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com09739001749

Outcome results