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 | Completed

• 1 other identifier: NB230024-OI
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Change in Haemoglobin [unit g/dl]

  To assess the effectiveness of the test treatment in terms of change in haemoglobin in blood sample

  From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm

• Change in Haematocrit [unit %]

  To assess the effectiveness of the test treatment in terms of change in haematocrit in blood sample

  From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm

• Change in RBC [unite 10^6/μl]

  To assess the effectiveness of the test treatment in terms of change in RBC in blood sample

  From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm

• Change in serum iron [unite μg/dL]

  To assess the effectiveness of the test treatment in terms of change in serum iron in blood sample

  From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm

• Change in serum ferritin level [unite μg/L]

  To assess the effectiveness of the test treatment in terms of change in serum ferritin level in blood sample

  From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm

Secondary Outcomes (23)

• Change in transferrin [unite mg/dL]

  From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm

• Change in transferrin saturation [unite %]

  From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm

• Change in iron binding capacity level [unite μg/dL]

  From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm

• Change in WBC count [unite 10^9/μl]

  From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm

• Change in SOD level [unite U/ml]

  From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Take the test treatment once a day with food

Dietary Supplement: placebo

Botanical Extract Standardised for Iron + Vitamin C

EXPERIMENTAL

The botanical extract standardised for iron and vitamin c is specially formulated for iron deficiency anaemia or anaemia. Vitamin C can promote the Iron absorption

Dietary Supplement: Botanical Extract Standardized for Iron + Vitamin C

Botanical Extract Standardised for Iron

EXPERIMENTAL

The botanical extract standardised for iron is formulated for iron deficiency anaemia or anaemia

Dietary Supplement: Botanical Extract Standardised for Iron

Interventions

placebo DIETARY_SUPPLEMENT

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

Placebo

Botanical Extract Standardized for Iron + Vitamin C DIETARY_SUPPLEMENT

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

Botanical Extract Standardised for Iron + Vitamin C

Botanical Extract Standardised for Iron DIETARY_SUPPLEMENT

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

Botanical Extract Standardised for Iron

Eligibility Criteria

• Age: 26 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 26 to 55 years (both inclusive) at the time of consent.
• Sex: Healthy males and non-pregnant/non-lactating females.
• Subject suffering from iron deficiency anaemia of mild to moderate type (Hb range of 8-11mg/dl)
• Subject must have negative Hepatitis B Surface Antigen (HBsAG)Test at screening.
• Females of childbearing potential must have a reported negative urine pregnancy test.
• If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
• Subject able to remain on stable usages of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
• Subject able to forgo changes in baseline medications and nutritional supplements during the study period.
• Subjects are willing to give written informed consent and are willing to follow the study procedure.
• Subjects who commit not to use prescribed or OTC medication containing iron supplements for treatment of iron deficiency or anemia except test treatments for the entire duration of the study.
• Subjects who are willing to use test treatments throughout the study period.

You may not qualify if:

• Subject having other blood disease or any malignancy.
• Subject with severe anemia (Hb \< 8mg/dl).
• Subject having any other chronic illness.
• Subject with history of allergy or sensitivity to the test treatment ingredients.
• Subject has a history of alcohol or drug addiction.
• Pregnant or breastfeeding or planning to become pregnant during the study period.
• Subject with history of acute blood loss.
• Subject having a history of surgery in last 3-6 months.
• Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials within the last four weeks.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Orgenetics, Inc.: collaborator

Study Sites (1)

NovoBliss Research Pvt.Ltd

Gandhinagar, Gujarat, India

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Iron; Ascorbic Acid

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Dr Nayan K Patel

  Medical Direcor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator) The study is double blind wherein neither the subjects nor the Investigator shall be aware of the test treatment allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator- Medical Director

Model Details: Randomized, Double-Blind, Parallel, Three-Arms, Placebo-Controlled

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: November 3, 2023
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: March 3, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)