Anemia, Iron DeficiencyNCT06096103
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
A study testing Botanical Extract Standardized for Iron + Vitamin C and Botanical Extract Standardised for Iron in people with Anemia, Iron Deficiency, run by NovoBliss Research Pvt Ltd at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 26 to 55 years
- Conditions the study is for
- Anemia, Iron Deficiency
- What is being tested?
- Botanical Extract Standardized for Iron + Vitamin C and Botanical Extract Standardised for Iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteIndia
- Study dates
- 3 Nov 2023to 9 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Anemia, Iron Deficiency
- Being tested
- placebo, Botanical Extract Standardized for Iron + Vitamin C, Botanical Extract Standardised for Iron
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary 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 Standardized for Iron + Vitamin CDietary 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 IronDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Take the test treatment once a day with food Receives: Dietary Supplement: placebo |
| 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 Receives: Dietary Supplement: Botanical Extract Standardized for Iron + Vitamin C |
| Botanical Extract Standardised for Iron | Experimental | The botanical extract standardised for iron is formulated for iron deficiency anaemia or anaemia Receives: Dietary Supplement: Botanical Extract Standardised for Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Haemoglobin [unit g/dl]
To assess the effectiveness of the test treatment in terms of change in haemoglobin in blood sample
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 outcomes (23)
Change in transferrin [unite mg/dL]
To assess the effectiveness of the test treatment in terms of change in transferrin in blood sample
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start3 Nov 2023
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Parallel, Three-Arms, Placebo-Controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Orgenetics, Inc.
- Responsible party
- Principal investigator, Dr Nayan Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr Nayan K Patel, Principal investigator, Medical Direcor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096103
- Sponsor's protocol ID
- NB230024-OI
- Status last verified
- Nov 2023
- First submitted
- 17 Oct 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06096103
- Acronym / sponsor ID
- NB230024-OI
- Conditions
- Anemia, Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Orgenetics, Inc.
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, Double-Blind, Parallel, Three-Arms, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: placeboTake the test treatment once a day with food |
| Botanical Extract Standardised for Iron + Vitamin C | Experimental | Dietary Supplement: Botanical Extract Standardized for Iron + Vitamin CThe 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 | Dietary Supplement: Botanical Extract Standardised for IronThe botanical extract standardised for iron is formulated for iron deficiency anaemia or anaemia |
Who may qualify
- Ages
- 26 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboRoute: Oral Dosage: 500mg Dosage Form: Capsule Frequency: Once a Day Duration: 60 Days Mode of Usage: Take the capsule once a day with food | Dietary supplement | Placebo |
| Botanical Extract Standardized for Iron + Vitamin CRoute: Oral Dosage: 500mg Dosage Form: Capsule Frequency: Once a Day Duration: 60 Days Mode of Usage: Take the capsule once a day with food | Dietary supplement | Botanical Extract Standardised for Iron + Vitamin C |
| Botanical Extract Standardised for IronRoute: Oral Dosage: 500mg Dosage Form: Capsule Frequency: Once a Day Duration: 60 Days Mode of Usage: Take the capsule once a day with food | Dietary supplement | Botanical Extract Standardised for Iron |
Primary outcome
Change in Haemoglobin [unit g/dl]
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
To assess the effectiveness of the test treatment in terms of change in haemoglobin in blood sample
Change in Haematocrit [unit %]
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
To assess the effectiveness of the test treatment in terms of change in haematocrit in blood sample
Change in RBC [unite 10^6/μl]
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
To assess the effectiveness of the test treatment in terms of change in RBC in blood sample
Change in serum iron [unite μg/dL]
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
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]
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
To assess the effectiveness of the test treatment in terms of change in serum ferritin level in blood sample
23 secondary outcomes
Change in transferrin [unite mg/dL]
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
Change in transferrin saturation [unite %]
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
Change in iron binding capacity level [unite μg/dL]
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
Change in WBC count [unite 10^9/μl]
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
Change in SOD level [unite U/ml]
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
QOL product perception questionnaire
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
Change in CBC value [unite 10^6/μL]
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
Abnormal change in iron status
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
Change in total serum cholesterol [unite mg/dL]
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
Change in triglyceride [unite mg/dL]
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
Change in random blood glucose [unite mg/dL]
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
Change in serum creatinine [unite mg/dL]
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
Change in uric acid [unite mg/dL]
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
Change in SGPT [unite U/L]
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
Change in SGOT [unite U/L]
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
Change in LDL level [unite mg/dL]
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
Change in HDL [unite mg/dL]
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
Abnormal change in presence of albumin [unite g/dL]
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
Change in blood glucose [unite mg/dL]
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
Change in urine pH
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
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
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
Change in deposits
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Nayan K Patel principal investigator
Medical Direcor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botanical Extract Standardized for Iron + Vitamin C and Botanical Extract Standardised for Iron in people with Anemia, Iron Deficiency, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Haemoglobin [unit g/dl] (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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.