Health Condition 1: E611- Iron deficiency
Conditions
Interventions
Intervention1: Tri-Fer
Capsules
: This product is a combination complementary medicine which assists in iron deficiency anaemia associated with hormone imbalance in women.
twice a day for 6 mon
Sponsors
Stockshift India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet the following criteria shall be considered eligible to participate in the study: 1.Subjects of age group between 18-50 years of womenââ?¬•s are included in the study. 2.Female population. 3.A diagnostic of mild-moderate iron deficient anemia due to Mild Hormonal imbalance. 4.Already established Mild Hormonal imbalance (Tri-Fer as therapy). 5.Subjects who are willing to give informed consent without any hindrance are included in the study.
Exclusion criteria
Exclusion criteria: 1. Subjects below 18 years and above 60 years of age are excluded from the study. 2. Patients with anemia caused by conditions other than iron deficiency. 3. Patients with abnormal laboratory test values at screening. 4. Patients with liver, kidney or circulatory system disease. 5. Patients with a history or present illness that is a malignant tumor or autoimmune disease. 6. Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening. 7. Patients who underwent oral administration of an iron preparation (including an over-the counter drug or supplement) within 4 weeks before the screening. 8. Severe anemia or Hormonal imbalance. 9. Patients who are undergoing or undergone Hormonal therapy in last one year. 10. PregnancyShift T R A N S F E R I N G V A L U E Page 24 11. Subjects with gastro or duodenal ulcers and are also afflicted with dysphagia & odynophagia are excluded from the study. 12. Subjects with persistent GI bleeding and frequent vomiting are excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be hemoglobin-levels improvements, measured before and after 3 months of Therapy of Tri-Fer Against the iron sulphateTimepoint: 3month, 6 Month | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the hormonal imbalance improvement in the treatment period. ââ?¬Â¢ To assess the hormonal imbalance under observation by hormonal questionnaire. ââ?¬Â¢ To assess Global overall symptom scale. ââ?¬Â¢ To assess Adverse eventsTimepoint: 3month, 6month | — |
Countries
India
Contacts
Public ContactDrGiriraja KV
Rajalakshmi Hospital
Outcome results
None listed