A clinical study to check the safety and effectiveness of test treatments in adult human subjects having anemia or iron-deficiency anemia
- Conditions
- Health Condition 1: D509- Iron deficiency anemia, unspecified
- Registration Number
- CTRI/2023/10/059283
- Lead Sponsor
- ORGENETICS INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method