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In this study the efficacy and safety of DigeZyme capsules will be studied in comparison to placebo in adult male or female patients suffering from Metabolic Health.

A prospective, randomized, double blind, placebo controlled, clinical study to evaluate the efficacy and safety of DigeZyme in the management of Metabolic Health.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/11/007456
Enrollment
60
Registered
2016-11-09
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 patients suffering from Metabolic Health Health Condition 2: E889- Metabolic disorder, unspecified

Interventions

Intervention1: DigeZyme®: One capsule thrice a day for 90 days. Control Intervention1: Placebo: One capsule thrice a day for 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-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 6 months. 2 Pathophysiologic/genetic syndromes associated with obesity. 3 Patients on prolonged 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. 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

Secondary

MeasureTime frame
1 Quality of Life Questionnaire. 2 Adverse Events.Timepoint: 1 Quality of Life Questionnaire(Day0,Day45 & Day90). 2 Adverse Events(Day45 & Day90).—

Primary

MeasureTime frame
1 Body weight and BMI. 2 Lipid Profile. 3 Stool Analysis. 4 Gut Health Questionnaire.Timepoint: 1 Body weight and BMI(Screening,Day45 & Day90) 2 Lipid Profile(Screening,Day45 & Day90) 3 Stool Analysis(Screening & Day90) 4 Gut Health Questionnaire(Day0,Day45 & Day90)—

Countries

India

Contacts

Public ContactMr Sanjib Panda

ClinWorld(P)Limited

kiran@clinworld.org08028397973

Outcome results

None listed

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