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| Name | Class |
|---|---|
| Orgenetics, Inc. | INDUSTRY |
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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
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Take the test treatment once a day with food |
|
| Botanical Extract Standardised for Iron + Vitamin C | Experimental | 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 |
|
| Botanical Extract Standardised for Iron | Experimental | The botanical extract standardised for iron is formulated for iron deficiency anaemia or anaemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Dietary Supplement | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in transferrin saturation [unite %] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Nayan K Patel | Medical Direcor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovoBliss Research Pvt.Ltd | Gandhinagar | Gujarat | India |
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Randomized, Double-Blind, Parallel, Three-Arms, Placebo-Controlled
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Double (Participant, Investigator) The study is double blind wherein neither the subjects nor the Investigator shall be aware of the test treatment allocation
| Botanical Extract Standardized for Iron + Vitamin C | Dietary Supplement | 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 | Dietary Supplement | 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 |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007501 | Iron |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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