Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Placebo: Mode of usage: Take the Capsule Once a Day with Food.
Route of administration
Oral
Intervention2: Botanical Extract Standardised for Iron + Vitamin C: Mode of Usage: Take the Capsule Once a Day with Food.
Route of Administration: Oral Administration.
Duration: 60 Days
Intervent
Sponsors
ORGENETICS INC
Eligibility
Inclusion criteria
Inclusion criteria: 1)Age: 26 to 55 years (both inclusive) at the time of consent. 2)Sex: Healthy males and non-pregnant/non-lactating females. 3)Subject suffering from iron deficiency anaemia of mild to moderate type (Hb range of 8-11mg/dl) 4)Subject must have negative Hepatitis B Surface Antigen (HBsAG)Test at screening. 5)Females of childbearing potential must have a reported negative urine pregnancy test. 6)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. 7)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. 8)Subject able to forgo changes in baseline medications and nutritional supplements during the study period. 9)Subjects are willing to give written informed consent and are willing to follow the study procedure. 10)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. 11)Subjects who are willing to use test treatments throughout the study period.
Exclusion criteria
Exclusion criteria: 1)Subject having other blood disease or any malignancy. 2)Subject with severe anemia (Hemoglobin value less than 8). 3)Subject having any other chronic illness. 4)Subject with history of allergy or sensitivity to the test treatment ingredients. 5)Subject has a history of alcohol or drug addiction. 6)Any other condition which could warrant exclusion from the study, as per the investigator’s discretion. 7)Pregnant or breastfeeding or planning to become pregnant during the study period. 8)Subject with history of acute blood loss. 9)Subject having a history of surgery in last 3-6 months. 10)Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the effectiveness of the test treatments in terms of change in blood parametes. i.e. Hemoglobin, Hematocrit, RBC, Serum Iron, Serum Ferritin levelTimepoint: 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
| Measure | Time frame |
|---|---|
| To assess the effectiveness of test treatments in terms of QoL product perception by the consumersTimepoint: 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;To assess the effectiveness of the test treatments in terms of changes in SOD level in blood samplesTimepoint: From baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 60 (± 2 Days) and compare with placebo arm;To assess the effectiveness of the test treatments in terms of changes in Transferrin, Transferrin Saturation, Total Iron Binding Capacity level in blood samplesTimepoint: 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;To assess the effectiveness of the test treatments in terms of changes in WBC counts in blood samplesTimepoint: 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;To assess the safety of the test treatments in terms of abnormal changes in CBC values, iron status, blood biochemical parameters, and urine parametersTimepoint: From baseline on screening visit before Day 01, before usage of test treatments on Day 01 and post-usage of test treatments on Day 30 (± 2 Days) and Day 60 (± 2 Days) and compare with placebo arm | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed