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

Phase 3

Completed

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

• Registration Number: CTRI/2022/06/043097
• Lead Sponsor: Ministry of Tribal Affairs

Brief Summary

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|Anemia is the most common hematological disorder and is one of the most common conditions seen in clinical practice. Iron deficiency anemia is the most common cause of anemia. Most the anemia are easy to treat and thereby improve a person’s productivity. Anemia management can range from simple to complex based on the underlying condition causing it. The most common reason for non-compliance with Iron therapy was found to be “forgetfulness†(63.0%) followed by “side effects†(49.5%) in a study. However another study showed that the leading reported reasons for non-adherence were side effects (63.3%).  The present study will explore the effect of the combination of two classical Ayurveda formulations viz., Mandur Vatak and Drakshavaleha on the level of hemoglobin in patients with moderate anemia without exhibiting side effects as compared to the standard of care. If found effective (non-inferior), it could be the first study to document the efficacy and safety of said formulations scientifically.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-15
• Study Completion: 2023-03-30
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• i.Participants of age between 18 to 55 years of any sex.
• ii.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 the 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
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 a score of FACIT –Fatigue scale disease-specific symptoms ]

Trial Locations

Locations (5)

Central Ayurveda Research Institute Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

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

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

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

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

Central Ayurveda Research Institute Bangalore

🇮🇳Bangalore, KARNATAKA, India

Dr S Dodamani

Principal investigator

9448085818

shd_ayu@yahoo.co.in