CTRI/2023/10/059283进行中（未招募）Unknown
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 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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