Status:
COMPLETED
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
Lead Sponsor:
NovoBliss Research Pvt Ltd
Collaborating Sponsors:
Orgenetics, Inc.
Conditions:
Anemia, Iron Deficiency
Eligibility:
All Genders
26-55 years
Phase:
NA
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 ad...
Detailed Description
The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. The adult female/male subjects will be instructed to...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Any other condition which could warrant exclusion from the study, as per the investigator's discretion.
- 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.
Key Trial Info
Start Date :
November 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2024
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06096103
Start Date
November 3 2023
End Date
February 9 2024
Last Update
March 3 2025
Active Locations (1)
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1
NovoBliss Research Pvt.Ltd
Gandhinagar, Gujarat, India