A Study to Evaluate the Safety and Benefits of Sugar Cut Ras in People with Diabetes and Diabetic Kidney Disease.

A Prospective, Open-Label, Multi-Arm, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of Sugar Cut Ras in Participants with Type 1 Diabetes, Type 2 Diabetes, and Diabetic Nephropathy. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112316

Enrollment

Registered

2026-06-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

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

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Men and women aged 18 to 65 years inclusive. 2. Arm A Established diagnosis of Type 1 Diabetes Mellitus T1DM. 3. Arm B Established diagnosis of Type 2 Diabetes Mellitus T2DM. 4. Arm C Diagnosed diabetic nephropathy with Urine Albumin to Creatinine Ratio UACR greater than or equal to 30 mg g at screening. 5. Glycated haemoglobin HbA1c greater than or equal to 7 percent and less than or equal to 10 percent at screening. 6. Willing and able to provide informed consent. 7. Willing and able to comply with all study procedures and follow up visits.

Exclusion criteria

Exclusion criteria: 1. Patients with major illnesses such as bronchial asthma, chronic obstructive pulmonary disease COPD, blood disorders, or active malignancies. 2. Pregnant or lactating women. 3. Participants with illnesses that may interfere with the investigator interpretation of study results. 4. Unstable or uncontrolled conditions including uncontrolled hypertension SBP 160 mmHg or higher or DBP 100 mmHg or higher, recent myocardial infarction within 6 months, unstable angina, decompensated heart failure, or clinically significant hepatic dysfunction AST or ALT more than 3 times the upper limit of normal. 5. Participation in another clinical drug trial within 3 months prior to recruitment. 6. Current alcohol or drug abuse, or a history of alcohol or drug abuse within 24 weeks before baseline.

Design outcomes

Primary

Measure	Time frame
1.Mean Change in HbA1c From Baseline to End of Study (Day 90) - Endpoint Definition: Change in HbA1c (percentage) from baseline to Day 90 as measured by standardized laboratory assays. - Specific Success Criterion: Proportion of participants achieving greater than or equal to 0.5 percentage absolute reduction in HbA1c by Day 90. Timepoint: Day 0- Visit 1 Day 30 2 days- Visit 2 Day 60 2 days- Visit 3 Day 90 2 days- Visit 4	—

Measure

Time frame

1.Mean Change in HbA1c From Baseline to End of Study (Day 90) - Endpoint Definition: Change in HbA1c (percentage) from baseline to Day 90 as measured by standardized laboratory assays. - Specific Success Criterion: Proportion of participants achieving greater than or equal to 0.5 percentage absolute reduction in HbA1c by Day 90. Timepoint: Day 0- Visit 1 Day 30 2 days- Visit 2 Day 60 2 days- Visit 3 Day 90 2 days- Visit 4

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Secondary

Measure	Time frame
1.Change in Total Daily Insulin Dose TDD from baseline to Day 90 in Arm A including 10 percent reduction rate & mean percent change in TDD 2. Change in Urine Albumin to Creatinine Ratio UACR from baseline to Day 90 in Arm C including 20 percent reduction rate & mean percent change in UACR 3. Change in Diabetes Distress Score DDS from baseline to Day 90 in all arms including 10 percent improvement rate & mean change in score 4. Safety & tolerability assessed by incidence & severity of adverse events AEs occurrence of serious adverse events SAEs & changes in vital signs & physical examination findings.Timepoint: Day 0- Visit 1 Day 30 2 days- Visit 2 Day 60 2 days- Visit 3 Day 90 2 days- Visit 4	—

Measure

Time frame

1.Change in Total Daily Insulin Dose TDD from baseline to Day 90 in Arm A including 10 percent reduction rate & mean percent change in TDD 2. Change in Urine Albumin to Creatinine Ratio UACR from baseline to Day 90 in Arm C including 20 percent reduction rate & mean percent change in UACR 3. Change in Diabetes Distress Score DDS from baseline to Day 90 in all arms including 10 percent improvement rate & mean change in score 4. Safety & tolerability assessed by incidence & severity of adverse events AEs occurrence of serious adverse events SAEs & changes in vital signs & physical examination findings.Timepoint: Day 0- Visit 1 Day 30 2 days- Visit 2 Day 60 2 days- Visit 3 Day 90 2 days- Visit 4

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Countries

India

Contacts

Public ContactMamatha B Gokavi

Ayubal Wellness Pvt. Ltd.

m.srinivas@samahitha.com07795188621

Outcome results