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

Anemia, Iron Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06096103
• Other study ID #: NB230024-OI
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: October 2023
• Source: NovoBliss Research Pvt Ltd
• Contact: Maheshvari N Patel
• Phone: 9909013236
• Email: maheshvari[@]novobliss.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency

Intervention

Dietary Supplement:
• placebo
Route: Oral Dosage: 500mg Dosage Form: Capsule Frequency: Once a Day Duration: 60 Days Mode of Usage: Take the capsule once a day with food
• Botanical Extract Standardized for Iron + Vitamin C
Route: Oral Dosage: 500mg Dosage Form: Capsule Frequency: Once a Day Duration: 60 Days Mode of Usage: Take the capsule once a day with food
• Botanical Extract Standardised for Iron
Route: Oral Dosage: 500mg Dosage Form: Capsule Frequency: Once a Day Duration: 60 Days Mode of Usage: Take the capsule once a day with food

Locations

Country	Name	City	State
India	NovoBliss Research Pvt.Ltd	Gandhinagar	Gujarat

Sponsors (2)

Lead Sponsor	Collaborator
NovoBliss Research Pvt Ltd	Orgenetics, Inc.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Haemoglobin [unit g/dl]	To assess the effectiveness of the test treatment in terms of change in haemoglobin in blood sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Primary	Change in Haematocrit [unit %]	To assess the effectiveness of the test treatment in terms of change in haematocrit in blood sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Primary	Change in RBC [unite 10^6/µl]	To assess the effectiveness of the test treatment in terms of change in RBC in blood sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Primary	Change in serum iron [unite µg/dL]	To assess the effectiveness of the test treatment in terms of change in serum iron in blood sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Primary	Change in serum ferritin level [unite µg/L]	To assess the effectiveness of the test treatment in terms of change in serum ferritin level in blood sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	Change in transferrin [unite mg/dL]	To assess the effectiveness of the test treatment in terms of change in transferrin in blood sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	Change in transferrin saturation [unite %]	To assess the effectiveness of the test treatment in terms of change in transferrin saturation in blood sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	Change in iron binding capacity level [unite µg/dL]	To assess the effectiveness of the test treatment in terms of change in iron binding capacity in blood sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	Change in WBC count [unite 10^9/µl]	To assess the effectiveness of the test treatment in terms of change in WBC count in blood sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	Change in SOD level [unite U/ml]	To assess the effectiveness of the test treatment in terms of change SOD level in blood sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	QOL product perception questionnaire	To assess the effectiveness of the test treatment in terms of treatment perception by using 9-point hedonic scale	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	Change in CBC value [unite 10^6/µL]	To assess the effectiveness of the test treatment in terms of change CBC value in blood sample	From baseline on screening visit before Day 01, before usage of test treatments on Day 01 and post-usage of test treatments on Day 30 (± 2 Days) and Day 60 (± 2 Days) and compare with placebo arm
Secondary	Abnormal change in iron status	To assess the effectiveness of the test treatment in terms of abnormal change iron status in blood sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	Change in total serum cholesterol [unite mg/dL]	To assess the effectiveness of the test treatment in terms of change in total serum cholesterol level in blood sample	From baseline on screening visit before Day 01, before usage of test treatments on Day 01 and post-usage of test treatments on Day 30 (± 2 Days) and Day 60 (± 2 Days) and compare with placebo arm
Secondary	Change in triglyceride [unite mg/dL]	To assess the effectiveness of the test treatment in terms of change in triglycerides in blood sample	From baseline on screening visit before Day 01, before usage of test treatments on Day 01 and post-usage of test treatments on Day 30 (± 2 Days) and Day 60 (± 2 Days) and compare with placebo arm
Secondary	Change in random blood glucose [unite mg/dL]	To assess the effectiveness of the test treatment in terms of change in random blood glucose in blood sample	From baseline on screening visit before Day 01, before usage of test treatments on Day 01 and post-usage of test treatments on Day 30 (± 2 Days) and Day 60 (± 2 Days) and compare with placebo arm
Secondary	Change in serum creatinine [unite mg/dL]	To assess the effectiveness of the test treatment in terms of change in serum creatinine in blood sample	From baseline on screening visit before Day 01, before usage of test treatments on Day 01 and post-usage of test treatments on Day 30 (± 2 Days) and Day 60 (± 2 Days) and compare with placebo arm
Secondary	Change in uric acid [unite mg/dL]	To assess the effectiveness of the test treatment in terms of change in uric acid in blood sample	From baseline on screening visit before Day 01, before usage of test treatments on Day 01 and post-usage of test treatments on Day 30 (± 2 Days) and Day 60 (± 2 Days) and compare with placebo arm
Secondary	Change in SGPT [unite U/L]	To assess the effectiveness of the test treatment in terms of change in SGPT in blood sample	From baseline on screening visit before Day 01, before usage of test treatments on Day 01 and post-usage of test treatments on Day 30 (± 2 Days) and Day 60 (± 2 Days) and compare with placebo arm
Secondary	Change in SGOT [unite U/L]	To assess the effectiveness of the test treatment in terms of change in SGOT in blood sample	From baseline on screening visit before Day 01, before usage of test treatments on Day 01 and post-usage of test treatments on Day 30 (± 2 Days) and Day 60 (± 2 Days) and compare with placebo arm
Secondary	Change in LDL level [unite mg/dL]	To assess the effectiveness of the test treatment in terms of change in LDL in blood sample	From baseline on screening visit before Day 01, before usage of test treatments on Day 01 and post-usage of test treatments on Day 30 (± 2 Days) and Day 60 (± 2 Days) and compare with placebo arm
Secondary	Change in HDL [unite mg/dL]	To assess the effectiveness of the test treatment in terms of change in HDL in blood sample	From baseline on screening visit before Day 01, before usage of test treatments on Day 01 and post-usage of test treatments on Day 30 (± 2 Days) and Day 60 (± 2 Days) and compare with placebo arm
Secondary	Abnormal change in presence of albumin [unite g/dL]	To assess the effectiveness of the test treatment in terms of abnormal change in presence of albumin in urine sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	Change in blood glucose [unite mg/dL]	To assess the effectiveness of the test treatment in terms of change in blood glucose in urine sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	Change in urine pH	To assess the effectiveness of the test treatment in terms of change in urine pH in urine sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	Change in colour of urine	To assess the effectiveness of the test treatment in terms of change in colour of urine	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	Change in appearance of urine	To assess the effectiveness of the test treatment in terms of change in appearance of urine	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm
Secondary	Change in deposits	To assess the effectiveness of the test treatment in terms of change in deposits in urine sample	From Baseline on Day 01 before usage of test treatments and post-usage of test treatments on Day 30 (+2 Days) and Day 60 (+2 Days) and compare with placebo arm