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In this study the Lactospore and Forslean combination will be studied in comparison to an inactive in adult male or female patients suffering with metabolic syndrome.

A prospective, randomized, double blind, placebo controlled clinical study to evaluate the efficacy and safety of LactoSpore and Forslean 20% combination in metabolic syndrome.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008146
Enrollment
60
Registered
2017-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Adult male or female subjects diagnosed with metabolic syndrome. Health Condition 2: E889- Metabolic disorder, unspecified

Interventions

Intervention1: LactoSpore and Forslean20%combination: One capsule twice a day for a period of 90 days. Control Intervention1: Placebo: One capsule twice a day for a period of 90 days.

Sponsors

Sami Labs Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Male and/or female patients. 2 Age between 18 to 65 years. 3 BMI between 30 to 34.9 Kg/m2 4 Willing to come for regular follow â??up visits. 5 Able to give written informed consent.

Exclusion criteria

Exclusion criteria: 1 Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months. 2 Pathophysiologic/ genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Praderwilli syndrome). 3 Patients on prolonged ( >6weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 4 Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) 5 Symptomatic patient with clinical evidence of Heart failure. 6 History of HIV and other viral infections. 7 Alcoholics and/or drug abusers. 8 Prior surgical therapy for obesity 9 H/o hypersensitivity to any of the trial drugs or their ingredients. 10 Pregnant / lactating woman.

Design outcomes

Primary

MeasureTime frame
â?¢Body weight and body mass index. â?¢Lipid Profile. â?¢Lab investigations. â?¢Gas and bloating, Stomach pain questionnaire. â?¢Gut health questionnaire.Timepoint: â?¢Body weight and body mass index (Screening, Day 45 & Day 90). â?¢Lipid Profile (Screening, Day 45 & Day 90). â?¢Lab investigations (Screening & Day 90). â?¢Gas and bloating, Stomach pain questionnaire (Day 0, Day 45 & Day 90). â?¢Gut health questionnaire (Day 0, Day 45 & Day 90).—

Secondary

MeasureTime frame
â?¢Quality of Life Questionnaire. â?¢Adverse events.Timepoint: â?¢Quality of Life Questionnaire(Day0,Day45 & Day90). â?¢Adverse events(Day45 & Day90).—

Countries

India

Contacts

Public ContactMr Chandu Devanpally

ClinWorld(P)Limited

kiran@clinworld.org08028397973

Outcome results

None listed

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