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A study to see if GlucoSEB Plus PB helps people with diabetes when taken with their regular medicine, compared to a dummy pill.

A single blind, placebo-controlled case study to determine efficacy of GlucoSEB Plus PB as adjuvant therapy in presence of GLP-1 agonist drug in diabetic adults - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088293
Enrollment
30
Registered
2025-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: GlucoSEB Plus PB: Dosage form: Capsule (500 mg) Frequency: 2 capsules per meal (Lunch and dinner) (Capsules taken 15 mins before meal) Route of administration: Oral. Control Interventio

Sponsors

Dr Prithvi K A
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.BMI 25 to 40 Kg/m2 2. Subjects with limited physical activity (not more than 30 min walk per day) 3. Subjects who consume GLP-1 agonist drug for sugar management; medicine dose stable for 2-3 months 4. Subjects willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating female. 2. BMI: less than 25 Kg/m2 and above 40 Kg/m2 3. Subjects taking any prescribed medicines other DPP-4 inhibitors and Alpha Glucosidase inhibitors drugs stable for 2-3 months 4. Diabetic patients (Type I) 5. Subjects with major chronic complications (including but not limited to) autoimmune disease, inflammation,etc. 6. Organic insufficiency (cardiac, hepatic, renal, respiratory) 7. Use of food supplements specifically containing fibres or polysaccharides 8. Chronic smoking and alcohol intake 9. Allergy to the ingredients in the test product. 10. History of any surgery in the past 3 months. 11. Subject currently taking or has in the past 30 days used GI related probiotics/prebiotics or any enzymes [prescription or over the counter (OTC)].

Design outcomes

Primary

MeasureTime frame
Assessment using SF-36 questionnaireTimepoint: 3 months—

Secondary

MeasureTime frame
1. Assessment using GSRS questionnaire (to check digestive health) 2. Change in anthropometric parameters (assessment on Day 0, Day 30 and Day 60): Body mass index (BMI), Waist circumference (WC), Waist-to-hip ratio (WHR) 3. Determining safety and tolerability of GlucoSEB Plus PB (from Day 0 to Day 60) 4. Rate of incidence of AE and SAE s (from Day 0 to Day 60)Timepoint: 3 months—

Countries

India

Contacts

Public ContactDr Prithvi K A

Sri Laxmi Hospital

drprithvika@gmail.com9632119076

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026