CTRI/2023/10/059283
Active, not recruiting
未知
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 - Nil
ORGENETICS INC0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ORGENETICS INC
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
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.
Outcomes
Primary Outcomes
Not specified
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