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A study to see if GlucoSEB Plus PB helps reduce withdrawal symptoms when diabetic adults stop GLP-1 medications.

A single blind, placebo-controlled case study to check alleviation of GLP-1 withdrawal symptoms in presence of GlucoSEB Plus PB in diabetic adults - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088288
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 Intervention

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 Subjects who have withdrawn from GLP-1 agonist drug treatment for at least one month. 4. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating female. 2. BMI: less than 25 Kg/m2 and above 40 Kg/m2 3. Diabetic patients (Type I) 4. Subjects with major chronic complications (including but not limited to) autoimmune disease, inflammation, etc. 5. Organic insufficiency (cardiac, hepatic, renal, respiratory) 6. Use of food supplements specifically containing fibers or polysaccharides 7. Chronic smoking and alcohol intake 8. Allergy to the ingredients in the test product. 9. History of any surgery in the past 3 months. 10. 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. Change in HbA1c (assessment on Day 0 and Day 90) 2. Change in fasting blood glucose (assessment on Day 0 and Day 90) 3. Change in Lipid profile (assessment on Day 0 and Day 90): TC, TG, LDL, HDL, and VLDL 4. Change in anthropometric parameters (assessment on Day 0 and Day 90): Body mass index (BMI), Waist circumference (WC), Waist-to-hip ratio (WHR) 5. GSRS questionnaire (to check digestive health) 6. Determining safety and tolerability of GlucoSEB Plus PB (from Day 0 to Day 90) 7. Rate of incidence of AE and SAE s (from Day 0 to Day 90)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