Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Punarnavadi Mandura - AFI Part- I, 19:1
API, Part-II, Vol.III): Dose: 500mg Twice daily.
Dosage form: Tablet
Rout of Administration: Oral
Time of Administration: Twice daily just after food.
Packing form: Pack of 60 tabs.
Anupana: Water
Sponsors
Central Council for Research In Ayurvedic Sciences CCRASMinistry Of Ayush Govt Of India
Eligibility
Inclusion criteria
Inclusion criteria: i. Participants of scheduled Caste community of any gender in the age group 18 to 55 years. ii. Hemoglobin index (Hb gm % ranging =8gm - =10gm.%) iii. Willing to provide informed written consent.
Exclusion criteria
Exclusion criteria: i. Recent history of blood loss from the gastro intestinal or other sources in the form of Haematemesis, Melena, Bleeding Piles, Hemoptysis, Menorrhagia, etc. ii. History or evidence of intestinal mal-absorption iii. History of Major co-morbidity/ serious chronic Renal/ Hepatic/ cardiac/ pulmonary diseases etc. iv. Known / diagnosed case of any other type of anaemia (sickle cell disease, thalassemia, other hemolytic anemia, bone marrow failure, etc). [apparent by history, physical examination, and/or laboratory tests if required.] v. Patients on prolonged ( > 6 weeks) medication for any chronic disease that may have an influence on the outcome of the study vi. Patient with diagnosis/ known history of Myelodysplastic syndromes, cancer etc. vii. Patients already on iron supplements at present or during the last 3 months viii. Pregnant women/ women who are planning for conception/lactating women ix. Any current medical condition, which the investigator considers would put the subject at unacceptable risk or affect study compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i.Mean Change in hemoglobin percentage from baseline.Timepoint: [Time frame: at baseline, 8th and 12th week ] | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Assessment of changes in disease specific symptoms. ii. Tolerability assessed by proportion of recruited participants remaining in the trial intervention. iii. Change in FACIT –Fatigue Scale. Timepoint: [Time frame: at baseline, 4th, 8th, 12th week and end of the 16th week] | — |
Countries
India
Contacts
Public ContactDR LAXMAN WAMAN BHURKE
RRAP Central Ayurveda Research Institute (CCRAS)
Outcome results
None listed