Back to resultsA 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
Primary Purpose
Anemia, Iron Deficiency
Status
Not yet recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
placebo
Botanical Extract Standardized for Iron + Vitamin C
Botanical Extract Standardised for Iron
Sponsored by
About this trial
This is an interventional prevention trial for Anemia, Iron Deficiency
Eligibility Criteria
Inclusion Criteria: Age: 26 to 55 years (both inclusive) at the time of consent. Sex: Healthy males and non-pregnant/non-lactating females. Subject suffering from iron deficiency anaemia of mild to moderate type (Hb range of 8-11mg/dl) Subject must have negative Hepatitis B Surface Antigen (HBsAG)Test at screening. Females of childbearing potential must have a reported negative urine pregnancy test. 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. 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. Subject able to forgo changes in baseline medications and nutritional supplements during the study period. Subjects are willing to give written informed consent and are willing to follow the study procedure. 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. Subjects who are willing to use test treatments throughout the study period. Exclusion Criteria: Subject having other blood disease or any malignancy. Subject with severe anemia (Hb < 8mg/dl). Subject having any other chronic illness. Subject with history of allergy or sensitivity to the test treatment ingredients. Subject has a history of alcohol or drug addiction. Any other condition which could warrant exclusion from the study, as per the investigator's discretion. Pregnant or breastfeeding or planning to become pregnant during the study period. Subject with history of acute blood loss. Subject having a history of surgery in last 3-6 months. Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials within the last four weeks.
Sites / Locations
- NovoBliss Research Pvt.Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Botanical Extract Standardised for Iron + Vitamin C
Botanical Extract Standardised for Iron
Arm Description
Take the test treatment once a day with food
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
The botanical extract standardised for iron is formulated for iron deficiency anaemia or anaemia
Outcomes
Primary Outcome Measures
Change in Haemoglobin [unit g/dl]
To assess the effectiveness of the test treatment in terms of change in haemoglobin in blood sample
Change in Haematocrit [unit %]
To assess the effectiveness of the test treatment in terms of change in haematocrit in blood sample
Change in RBC [unite 10^6/μl]
To assess the effectiveness of the test treatment in terms of change in RBC in blood sample
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
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
Secondary Outcome Measures
Change in transferrin [unite mg/dL]
To assess the effectiveness of the test treatment in terms of change in transferrin in blood sample
Change in transferrin saturation [unite %]
To assess the effectiveness of the test treatment in terms of change in transferrin saturation in blood sample
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
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
Change in SOD level [unite U/ml]
To assess the effectiveness of the test treatment in terms of change SOD level in blood sample
QOL product perception questionnaire
To assess the effectiveness of the test treatment in terms of treatment perception by using 9-point hedonic scale
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
Abnormal change in iron status
To assess the effectiveness of the test treatment in terms of abnormal change iron status in blood sample
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
Change in triglyceride [unite mg/dL]
To assess the effectiveness of the test treatment in terms of change in triglycerides in blood sample
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
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
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
Change in SGPT [unite U/L]
To assess the effectiveness of the test treatment in terms of change in SGPT in blood sample
Change in SGOT [unite U/L]
To assess the effectiveness of the test treatment in terms of change in SGOT in blood sample
Change in LDL level [unite mg/dL]
To assess the effectiveness of the test treatment in terms of change in LDL in blood sample
Change in HDL [unite mg/dL]
To assess the effectiveness of the test treatment in terms of change in HDL in blood sample
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
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
Change in urine pH
To assess the effectiveness of the test treatment in terms of change in urine pH in urine sample
Change in colour of urine
To assess the effectiveness of the test treatment in terms of change in colour of urine
Change in appearance of urine
To assess the effectiveness of the test treatment in terms of change in appearance of urine
Change in deposits
To assess the effectiveness of the test treatment in terms of change in deposits in urine sample
Full Information
NCT ID
NCT06096103
First Posted
October 17, 2023
Last Updated
October 21, 2023
Sponsor
NovoBliss Research Pvt Ltd
Collaborators
Orgenetics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT06096103
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NovoBliss Research Pvt Ltd
Collaborators
Orgenetics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-Blind, Parallel, Three-Arms, Placebo-Controlled
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Investigator) The study is double blind wherein neither the subjects nor the Investigator shall be aware of the test treatment allocation
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Take the test treatment once a day with food
Arm Title
Botanical Extract Standardised for Iron + Vitamin C
Arm Type
Experimental
Arm 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
Arm Title
Botanical Extract Standardised for Iron
Arm Type
Experimental
Arm Description
The botanical extract standardised for iron is formulated for iron deficiency anaemia or anaemia
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Botanical Extract Standardized for Iron + Vitamin C
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Botanical Extract Standardised for Iron
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Haemoglobin [unit g/dl]
Description
To assess the effectiveness of the test treatment in terms of change in haemoglobin in blood sample
Time Frame
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
Title
Change in Haematocrit [unit %]
Description
To assess the effectiveness of the test treatment in terms of change in haematocrit in blood sample
Time Frame
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
Title
Change in RBC [unite 10^6/μl]
Description
To assess the effectiveness of the test treatment in terms of change in RBC in blood sample
Time Frame
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
Title
Change in serum iron [unite μg/dL]
Description
To assess the effectiveness of the test treatment in terms of change in serum iron in blood sample
Time Frame
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
Title
Change in serum ferritin level [unite μg/L]
Description
To assess the effectiveness of the test treatment in terms of change in serum ferritin level in blood sample
Time Frame
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 Outcome Measure Information:
Title
Change in transferrin [unite mg/dL]
Description
To assess the effectiveness of the test treatment in terms of change in transferrin in blood sample
Time Frame
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
Title
Change in transferrin saturation [unite %]
Description
To assess the effectiveness of the test treatment in terms of change in transferrin saturation in blood sample
Time Frame
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
Title
Change in iron binding capacity level [unite μg/dL]
Description
To assess the effectiveness of the test treatment in terms of change in iron binding capacity in blood sample
Time Frame
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
Title
Change in WBC count [unite 10^9/μl]
Description
To assess the effectiveness of the test treatment in terms of change in WBC count in blood sample
Time Frame
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
Title
Change in SOD level [unite U/ml]
Description
To assess the effectiveness of the test treatment in terms of change SOD level in blood sample
Time Frame
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
Title
QOL product perception questionnaire
Description
To assess the effectiveness of the test treatment in terms of treatment perception by using 9-point hedonic scale
Time Frame
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
Title
Change in CBC value [unite 10^6/μL]
Description
To assess the effectiveness of the test treatment in terms of change CBC value in blood sample
Time Frame
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
Title
Abnormal change in iron status
Description
To assess the effectiveness of the test treatment in terms of abnormal change iron status in blood sample
Time Frame
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
Title
Change in total serum cholesterol [unite mg/dL]
Description
To assess the effectiveness of the test treatment in terms of change in total serum cholesterol level in blood sample
Time Frame
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
Title
Change in triglyceride [unite mg/dL]
Description
To assess the effectiveness of the test treatment in terms of change in triglycerides in blood sample
Time Frame
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
Title
Change in random blood glucose [unite mg/dL]
Description
To assess the effectiveness of the test treatment in terms of change in random blood glucose in blood sample
Time Frame
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
Title
Change in serum creatinine [unite mg/dL]
Description
To assess the effectiveness of the test treatment in terms of change in serum creatinine in blood sample
Time Frame
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
Title
Change in uric acid [unite mg/dL]
Description
To assess the effectiveness of the test treatment in terms of change in uric acid in blood sample
Time Frame
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
Title
Change in SGPT [unite U/L]
Description
To assess the effectiveness of the test treatment in terms of change in SGPT in blood sample
Time Frame
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
Title
Change in SGOT [unite U/L]
Description
To assess the effectiveness of the test treatment in terms of change in SGOT in blood sample
Time Frame
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
Title
Change in LDL level [unite mg/dL]
Description
To assess the effectiveness of the test treatment in terms of change in LDL in blood sample
Time Frame
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
Title
Change in HDL [unite mg/dL]
Description
To assess the effectiveness of the test treatment in terms of change in HDL in blood sample
Time Frame
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
Title
Abnormal change in presence of albumin [unite g/dL]
Description
To assess the effectiveness of the test treatment in terms of abnormal change in presence of albumin in urine sample
Time Frame
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
Title
Change in blood glucose [unite mg/dL]
Description
To assess the effectiveness of the test treatment in terms of change in blood glucose in urine sample
Time Frame
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
Title
Change in urine pH
Description
To assess the effectiveness of the test treatment in terms of change in urine pH in urine sample
Time Frame
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
Title
Change in colour of urine
Description
To assess the effectiveness of the test treatment in terms of change in colour of urine
Time Frame
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
Title
Change in appearance of urine
Description
To assess the effectiveness of the test treatment in terms of change in appearance of urine
Time Frame
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
Title
Change in deposits
Description
To assess the effectiveness of the test treatment in terms of change in deposits in urine sample
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 26 to 55 years (both inclusive) at the time of consent.
Sex: Healthy males and non-pregnant/non-lactating females.
Subject suffering from iron deficiency anaemia of mild to moderate type (Hb range of 8-11mg/dl)
Subject must have negative Hepatitis B Surface Antigen (HBsAG)Test at screening.
Females of childbearing potential must have a reported negative urine pregnancy test.
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.
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.
Subject able to forgo changes in baseline medications and nutritional supplements during the study period.
Subjects are willing to give written informed consent and are willing to follow the study procedure.
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.
Subjects who are willing to use test treatments throughout the study period.
Exclusion Criteria:
Subject having other blood disease or any malignancy.
Subject with severe anemia (Hb < 8mg/dl).
Subject having any other chronic illness.
Subject with history of allergy or sensitivity to the test treatment ingredients.
Subject has a history of alcohol or drug addiction.
Any other condition which could warrant exclusion from the study, as per the investigator's discretion.
Pregnant or breastfeeding or planning to become pregnant during the study period.
Subject with history of acute blood loss.
Subject having a history of surgery in last 3-6 months.
Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials within the last four weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maheshvari N Patel
Phone
9909013236
Email
maheshvari@novobliss.in
First Name & Middle Initial & Last Name or Official Title & Degree
Sheetal J Khandwala
Email
bd@novobliss.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Nayan K Patel
Organizational Affiliation
Medical Direcor
Official's Role
Principal Investigator
Facility Information:
Facility Name
NovoBliss Research Pvt.Ltd
City
Gandhinagar
State/Province
Gujarat
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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