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A Clinical Study to Check the Safety and Effectiveness of Botanical Extract Standardized for Iron + Vitamin C and Botanical Extract Standardized for Iron in Adult Human Subjects with Anemia or Iron-deficiency Anemia

NCT06096103 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-03-03

No results posted yet for this study

Summary

A randomized, double-blind, parallel, three-arms, placebo-controlled, safety and efficacy study of Botanical Extract Standardized for Iron + Vitamin C and Botanical Extract Standardized for Iron in adult human subjects with anemia or iron-deficiency anemia.

A total of up to 96 adult male and female subjects of age 26 to 55 years (32 subjects/arm) will be enrolled to get 90 evaluable subjects (30 subjects/arm) in the study

Conditions

  • Anemia, Iron Deficiency

Interventions

DIETARY_SUPPLEMENT

placebo

Route: Oral Dosage: 500mg Dosage Form: Capsule Frequency: Once a Day Duration: 60 Days Mode of Usage: Take the capsule once a day with food

DIETARY_SUPPLEMENT

Botanical Extract Standardized for Iron + Vitamin C

Route: Oral Dosage: 500mg Dosage Form: Capsule Frequency: Once a Day Duration: 60 Days Mode of Usage: Take the capsule once a day with food

DIETARY_SUPPLEMENT

Botanical Extract Standardised for Iron

Route: Oral Dosage: 500mg Dosage Form: Capsule Frequency: Once a Day Duration: 60 Days Mode of Usage: Take the capsule once a day with food

Sponsors & Collaborators

  • Orgenetics, Inc.

    collaborator INDUSTRY

  • NovoBliss Research Pvt Ltd

    lead OTHER

Principal Investigators

  • Dr Nayan K Patel · Medical Direcor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
26 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-03
Primary Completion
2024-02-09
Completion
2024-02-09

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06096103 on ClinicalTrials.gov