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

NovoBliss Research

Status: Completed

Conditions: Anemia, Iron Deficiency

Treatments: Dietary Supplement: Botanical Extract Standardised for Iron; Dietary Supplement: Botanical Extract Standardized for Iron + Vitamin C; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06096103

NB230024-OI

Details and patient eligibility

About

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.

A total of up to 96 adult male and female subjects of age 26 to 55 years (32 subjects/arm) will be enrolled to get 90 evaluable subjects (30 subjects/arm) in the study

Full 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 visit the facility as per the below visits. There will be total of 4 visits in this study.

• Visit 01 (Within 30 Days): Screening procedure, informed consent obtain process, baseline evaluations, blood collection, urine collection.
• Visit 02 (Day 01): Enrolment, randomization, product distribution, subject diary distribution, blood collection.
• Visit 03 (Day 30 ± 2 Days): Treatment period, blood collection, evaluations, consumer's QoL product perception questionnaire, subject diary review, AE reporting (if any).
• Visit 04 (Day 60 ± 2 Days): End of study process, evaluation, blood collection, urine collection, consumer's QoL and product perception questionnaire, subject diary collection, test treatments accountability, AE reporting (if any).

Assessment of efficacy parameters before test treatment usage will be done on screening visit within 30 days of Day 01, on Day 01 and after test treatment usage will be done on Day 30 (± 2 Days) and Day 60 (± 2 Days).

Blood Parameter Analysis: Hemoglobin, Hematocrit, RBC, WBC, MCV, MCH, MCHC, Serum Iron, Serum ferritin, Transferrin, Transferrin Saturation, Total Iron Binding Capacity, Total Cholesterol, Triglycerides, Random Glucose, Serum Creatinine, Uric Acid, SGPT, SGOT, LDL, HDL, HBsAG, SOD.

Urine Parameter: Chemical Parameters - Albumin, Blood, Glucose, pH; Physcial Parameters - Colour, Appearance and Deposits.

QoL Product Perception: Fatigue, Mood, Sleepiness, GI Discomfort, Energy Level, Epigastric Discomfort, Nausea, Diarrhoea, Constipation

Enrollment: 96 patients

Sex: All

Ages: 26 to 55 years old

Volunteers: No Healthy Volunteers

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

1. Subject having other blood disease or any malignancy.
2. Subject with severe anemia (Hb < 8mg/dl).
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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Take the test treatment once a day with food

Treatment:

Dietary Supplement: placebo

Botanical Extract Standardised for Iron + Vitamin C

Experimental group

Description:

The botanical extract standardised for iron and vitamin c is specially formulated for iron deficiency anaemia or anaemia. Vitamin C can promote the Iron absorption

Treatment:

Dietary Supplement: Botanical Extract Standardized for Iron + Vitamin C

Botanical Extract Standardised for Iron

Experimental group

Description:

The botanical extract standardised for iron is formulated for iron deficiency anaemia or anaemia

Treatment:

Dietary Supplement: Botanical Extract Standardised for Iron