A Clinical Study to Check the Safety and Effectiveness of Botanical Extract Standardized for Iron… (NCT06096103) | Clinical Trial Compass
CompletedNot Applicable
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
India96 participantsStarted 2023-11-03
Plain-language 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
Who can participate
Age range26 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Subject having other blood disease or any malignancy.
✕. Subject with severe anemia (Hb \< 8mg/dl).
✕
What they're measuring
1
Change in Haemoglobin [unit g/dl]
Timeframe: 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
2
Change in Haematocrit [unit %]
Timeframe: 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
3
Change in RBC [unite 10^6/μl]
Timeframe: 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
4
Change in serum iron [unite μg/dL]
Timeframe: 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
5
Change in serum ferritin level [unite μg/L]
Timeframe: 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