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Efficacy and Safety of Wellmune® Capsules in Diabetes Mellitus Patients.

Efficacy and Safety of Wellmune Capsules as an Add-On Therapy to Conventional Therapy in Patients with Type 2 Diabetes Mellitus.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042729
Enrollment
80
Registered
2022-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-30

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: Wellmune® Capsules (Highly purified (1-3) (1-6) β-Glucan 100mg, Elderberry 300mg, Acerola 200mg, Vitamin C 40mg, Zinc 8mg) along with Oral Hypoglycemic Agents.: Metformin (500 mg, onc

Sponsors

MMC Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. T2DM Patients of both genders aged above 18 years. 2. Patients with Uncontrolled HbA1c (>=7%) levels. 3. Patient or the Patientâ??s Legally Acceptable Representative signs and dates a written, informed consent form prior to initiation of data collection. 4.Patient should be capable of understanding the written, informed consent and have to agree to the protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Type 1 Diabetes Mellitus Patients. 2. Contraindications to any of the drugs in the Treatment course 3. Patients with any other Co-morbid disease conditions such as Renal Disease, Pregnancy contraindications and Hepatic Cirrhosis or abnormal Liver Function. 4. In the opinion of Physician, the patient has various other reasons of medical and non-medical characters, in that case Physician can prevent patient from participation of study. 5. Pregnant and Lactating Women

Design outcomes

Primary

MeasureTime frame
Reduction of Fasting Blood Glucose (FBG), Post Prandial Blood Glucose (PPBG) and Glycated Hemoglobin (HbA1C) Levels in T2DM patients.Timepoint: At the end of 3 months and 6 months.—

Secondary

MeasureTime frame
1. Changes in Anthropometric Measurements such as Body Weight, Body Mass Index (BMI)and Body Circumferences (Waist, Hip, and Limbs). 2. Number of Patients requiring increase in Metformin Dose/Another OHA/Addition of Insulin and Withdrawal from the Trial due to Attrition Rate. 3. Improvement of Quality of life. Timepoint: At the end of 3 months and 6 months—

Countries

India

Contacts

Public ContactMs Roopini R

SRM INSTITUTE OF SCIENCE AND TECHNOLOGY

sarumats@srmist.edu.in7010530419

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026