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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Anemia, Iron Deficiency

Intervention / Treatment
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* Dietary Supplement: placebo
* Dietary Supplement: Botanical Extract Standardized for Iron + Vitamin C
* Dietary Supplement: Botanical Extract Standardised for Iron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double-Blind, Parallel, Three-Arms, Placebo-Controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Take the test treatment once a day with food | Dietary Supplement: placebo<br>* 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<br>|
| Experimental: Botanical Extract Standardised for Iron + Vitamin C<br>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 | Dietary Supplement: Botanical Extract Standardized for Iron + Vitamin C<br>* 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<br>|
| Experimental: Botanical Extract Standardised for Iron<br>The botanical extract standardised for iron is formulated for iron deficiency anaemia or anaemia | Dietary Supplement: Botanical Extract Standardised for Iron<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 %] | 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 |