Determining the Optimum Dose, Efficacy and Safety of a Herbal Formulation, Link Gluconorm (LG) as add on therapy in the treatment of patients with uncomplicated diabetes mellitus: A Randomized, Double-blinded, Placebo Controlled Phase II Clinical Trial

Randomized, double-blinded, placebo-controlled, phase II Clinical Trial to determine the optimum dose, efficacy and safety of LG, a herbal formulation as add on therapy for uncomplicated type 2 diabetes mellitus

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2024/025

Enrollment

Unknown

Registered

2024-08-09

Start date

2024-08-20

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Type 2 diabetes mellitus

Interventions

Setting: The study will be conducted at the Colombo Municipal clinic (CMC) in Slave Island, Sri Lanka. Patients who have been diagnosed with type 2 diabetes mellitus (T2DM) who fulfill both the inclus

Eligibility

Inclusion criteria

Inclusion criteria: • Males and females age 18–70 years • Diagnosed with type-2 diabetes mellitus during the last 5 years • Currently only taking metformin 500 mg twice a day for not more than 3 months • HbA1c 6.5–8.0% and FBS 126–200 mg/dl (Diabetes is defined as the presence of FPG more than 126mg/dL (7.0 mmol/L))

Exclusion criteria

Exclusion criteria: • Patients with an allergy to ingredients of LG • Alcohol consumption > 20 g/day • Patients using insulin therapy • Use of any herbal medications or herbal supplements, if any, were not discontinued at least 4 weeks prior to entry into the study. • Patients with raised baseline serum creatinine level (>1.5 mg/dl in men or > 1.2 mg/dl in women) • Lactation, pregnancy • Patients with diagnosed alcoholic liver disease (ALD), cirrhosis or abnormal baseline liver function tests (AST or ALT > 40 IU/ L) • Patients with malignancy • Patients with unrelated chronic illness • Diabetic retinopathy or neuropathy • Patients with cardiac, liver or respiratory failure • Any condition that, in the opinion of the clinician, would contraindicate the patient’s participation

Design outcomes

Primary

Measure	Time frame
Reduction of the hemoglobin A1c (HbA1c) from baseline to Week 12. [Baseline and at 12th week]	—

Secondary

Measure	Time frame
Reduction of the FPG from baseline to Weeks 4, 8, and 12. [Baseline and at 4th,8th and 12th weeks.] Reduction of the fasting serum Insulin from baseline to Weeks 4, 8, and 12. [ Baseline and at 4th,8th and 12th weeks.] Reduction of the serum fructosamine from baseline to Weeks 4, 8, and 12. [ Baseline and at 4th,8th and 12th weeks.]	—

Countries

Sri Lanka

Contacts

Public ContactProf. Jennifer Perera,

Emeritus Professor

jennifer_perera55@yahoo.com0776096002

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026