Community based study to evaluate Ayurvedic formulation (Punarnavadi Mandura) in Pandu Roga (Anemia) ?
- Conditions
- Health Condition 1: D509- Iron deficiency anemia, unspecified
- Registration Number
- CTRI/2021/07/034967
- Lead Sponsor
- Central Council for Research In Ayurvedic Sciences CCRASMinistry Of Ayush Govt Of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method i.Mean Change in hemoglobin percentage from baseline.Timepoint: [Time frame: at baseline, 8th and 12th week ]
- Secondary Outcome Measures
Name Time Method i.Assessment of changes in disease specific symptoms. <br/ ><br>ii.Tolerability assessed by proportion of recruited participants remaining in the trial intervention. <br/ ><br>iii.Change in FACIT –Fatigue Scale. <br/ ><br>Timepoint: [Time frame: at baseline, 4th, 8th, 12th week and end of the 16th week]