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A clinical study to evaluate the safety and efficacy of study drug for iron repletion in adult male or female patients suffering with iron deficiency anaemia as supplement to the treatment.

A double-blind, randomized, comparative clinical study to evaluate the safety and efficacy of study drug for iron repletion in adult male or female patients suffering with iron deficiency anaemia as supplement/adjuvant to the treatment. - Anemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055267
Enrollment
60
Registered
2023-07-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: D509- Iron deficiency anemia, unspecified

Interventions

None listed

Sponsors

YourZooki holdings Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either gender 18 to 70 years (inclusive) Subjects giving written informed consent /assent form Patients having presence of iron deficiency anemia below normal or low hemoglobin as per lab reports. Non-use of any iron supplement for 2 weeks prior to enrolment to the study and to know the dosage timing of Calcium supplement if any. Willing to come for regular follow-up visits. In the opinion of the investigator, able to comply with the requirements of the protocol.

Exclusion criteria

Exclusion criteria: Patients with serious cardiovascular, cerebro-vascular respiratory liver or renal disease or any other disorder. Known history of hypersensitivity to herbal extracts or dietary supplements. Known or suspected hypersensitivity to iron or any of the components of Investigational Product. Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy. Medical history of current hematological disorders other than iron deficiency anemia (e.g. aplastic anemia, megaloblastic anemia, sideroblastic anemia, pernicious anemia, thalassemia, sickle cell anemia, etc.). Evidence of alcohol or drug abuse, that may, in the opinion of the Investigator interferes with study compliance or prevents understanding of the objectives, investigational procedures or possible consequences of the study.

Design outcomes

Primary

MeasureTime frame
Change in hematological parameters CBC RBC indices from baseline to Day 15 Day 30Timepoint: Day 15 Day 30

Secondary

MeasureTime frame
Change in quality of life (QoL assessed by SF-36) from baseline to Day 15 Day 30Timepoint: Day 15 Day 30

Countries

India

Contacts

Public ContactShalini Dayananda

Unitree Health Care Diagnostics

unitreeclinicalresearch@gmail.com9854270377

Outcome results

None listed

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