None listed
Conditions
Interventions
Intervention1: Acculips: The subjects are given with either intervention product or comparator product for daily use for upto three months. Initail day of study, Subjects haematology is measure and af
Sponsors
Accuprec Research Labs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Normal healthy human volunteers with/without low haemoglobin, total RBCs should be included. 2) Women between the age above 18 to 65 years. 3) Patients willing to sign an informed written consent and comply with visit schedules. 4) Patients must be able to communicate effectively with study personnel.
Exclusion criteria
Exclusion criteria: 1) Known positive status and known history for diabetes, artificial coloring agents allergy. 2) Pregnant or breast feeding women. 3) Volunteers should not have any disease. Especially cancer, auto-immune diseases, Rheumatoid arthritis, psoriasis, acidity, peptic ulcers, epilepsy, ulcerative colitis, parkinsonâ??s disease etc. should not be included. 4) Subjects on therapy of anti-coagulants, anti-plaelets agents, statins etc. should not be included. 5) Subjects having history of/known status of Thyroid gland related problems. 6) Subjects consuming excess of vitamin C. 7) Subjects following any diet/nutritional programs. 8) Subjects who are addicted to smoking or alcohol should not be included. 9) Subjects on any other experimental treatment within 07 days of the first dose of study drug or who have not recovered from the side effects of such therapy. 10) Patient have history of hospitalized treatment before 07 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate subjectâ??s clinical conditions by measuring blood concentrations of haemoglobin, total RBCs, Serum Iron, Serum folate and Serum Vit. B12Timepoint: Visit 1 (Screening Visit at 1st day of clinical study upto 03 months) Informed consent Full medical history Hemoglobin CBC Serum Folate Serum Iron Serum Vit. B12 Record of all measurable data Visit 2, 3, 4 (After 01, 02, 03 months of clinical study respectively) Hemoglobin CBC Serum Folate Serum Iron Serum Vit. B12 Any adverse event observed | — |
Secondary
| Measure | Time frame |
|---|---|
| Observing any Side effects and serious reactionTimepoint: Any adverse event shall be immediately notified to sponsor upon receiving information by Principal Investigator. At each follow-up visit starting from completion of one month till the end of the study and one month after the study completion, subjects will be consulted regarding any adverse effects or side effect is being observed. | — |
Countries
India
Contacts
Public ContactDr Manish Rachchh
Accuprec Research Labs Pvt. Ltd.
Outcome results
None listed