Health Condition 1: D539- Nutritional anemia, unspecified
Conditions
Interventions
Intervention1: Dhatri Lauha: Dhatri Lauha - API,
Part- I, 21:2 pg- 743-744
Dose: 500mg Twice daily.
Rout of Administration: Oral
Duration of Therapy: 12 weeks(3 month)
Dosage form: Tablet
Time
Sponsors
Ministry of Tribal Affairs
Ministry of AYUSH
Eligibility
Inclusion criteria
Inclusion criteria: i. Participants of scheduled Tribe 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. Pregnant women/ women who are planning for conception/lactating women viii. Patients already on iron supplements at present or during the last 3 months 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, 4th, 8th, 12th week and end of the 16th 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 Kalpana B Kachare
Central Council for Research in Ayurvedic Sciences , New Delhi
Outcome results
None listed