Evaluation of efficacy and tolerability of select Ayurveda formulations in moderate Iron Deficiency Anemia

Phase 3

Not yet recruiting

• Conditions: Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH,

• Registration Number: CTRI/2022/06/043305
• Lead Sponsor: Central Council for Research In Ayurvedic Sciences CCRASMinistry Of Ayush Govt Of India

Brief Summary

The study is being conducted  to evaluate theeffect of *Mandur Vatak*and*Drakshavaleha*(ayurvedamedicines)in improving haemoglobin (gm/dl)    in  moderate iron deficiency anemia. The participants of any sex andof age between 18     to 55 years, belonging to any caste willbe selected from out-reach OPD in identified SC dominant areas.  It is a Open label, interventional,multicentre, randomized controlled  study. Participants having   Hemoglobinranging between 8 – 10.9 gm /dl, Hematocrit less than 41% in men and   less than 36% in women and Mean corpuscular volume lessthan 80% will be taken into study. The duration of study will be 1 year withsample size 320 (Group I -160  & Group II -160) . Primaryoutcome of the study is change in hemoglobin level as compare to standard ofcare.[Time frame: at baseline, and at the end of 12th week].

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-18
• Last Update Posted: 2022-10-11

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Participants of age between 18 to 55 years of any sex.
• Hemoglobin ranging between 8 to 10.9 gm/dl iii.
• Hematocrit less than 41% in men and less than 36% in women iv.
• Mean corpuscular volume less than 80% v.
• Willing to provide informed written consent for participation in study.

Exclusion Criteria

• i.Recent history of severe acute or chronic blood loss from the gastro intestinal or other sources in the form of Haematemesis, Melena, Bleeding Piles, Hemoptysis, Menorrhagia, surgery, trauma, etc.
• ii.Participants suffering from megaloblastic anemia (pernicious anemia) (Serum Vit.
• B12<150 pg/ml) or Hypothyroidism (TSH>10 mIU/L) iii.Patients already on iron supplements at present or during the last 3 months iv.Known case of disease conditions with intestinal malabsorption, alcohol use disorder (AUD) (CAGE score >2), anaemia due to chronic disease and medications, Thalassemia, Sideroblastic anemia, sickle cell, cold hemoglobinuria (Donath-Landsteiner hemolytic anemia), cold agglutinin disease (cold antibody hemolytic anemia), and other hemolytic anemias disseminated intravascular coagulation (DIC), Bone marrow suppression (aplastic anemia and myelophthisic anemia), Myelodysplastic syndromes, mechanical heart valves, hemolytic uremic syndrome (HUS), etc.
• Known case of other major co-morbidities like chronic cardiac/ pulmonary diseases, malignancy, etc.
• vi.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
• creatinine > 1.2mg/dl) vii.Patients on prolonged (> 6 weeks) medication (steroids, immune-suppressants, disease modifying agents, chemotherapy etc.) for any chronic disease that may have an influence on the outcome of the study viii.
• Pregnant women or women who are planning for conception or lactating mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
i.Change in hemoglobin level as compare to standard of care.	at baseline, and at the end of 12th week

Secondary Outcome Measures

Name	Time	Method
i.Proportion of participants achieving a hemoglobin increase of ≥2 g dL	ii.Change in score of FACIT –Fatigue scale disease specific symptoms

Trial Locations

Locations (8)

Central Ayurveda Research Institute, Guwahati; 🇮🇳 Kamrup, ASSAM, India

Central Ayurveda Research Institute, Punjabi Bagh New Delhi; 🇮🇳 West, DELHI, India

Raja Ramdeo Anandilal Podar (RRAP) Central Ayurveda Research Institute, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Regional Ayurveda Research Institute, Gwalior; 🇮🇳 Gwalior, MADHYA PRADESH, India

Regional Ayurveda Research Institute, Jammu; 🇮🇳 JAMMU, & KASHMIR, India

Regional Ayurveda Research Institute, Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

Regional Ayurveda Research Institute, Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Regional Ayurveda Research Institute, Thiruvananthapuram; 🇮🇳 Thiruvananthapuram, KERALA, India

Central Ayurveda Research Institute, Guwahati

🇮🇳Kamrup, ASSAM, India

Dr Praveen Kumar K S

Principal investigator

9447506528

drpraveenkumarks@gmail.com