Punarnavadi Mandura vs Punarnavadi Mandura-Drakshavaleha vs Iron Folic Acid (IFA) in Iron deficiency anemia among non-pregnant women of reproductive age group

Phase 2/3

Not yet recruiting

Conditions: Endocrine, nutritional and metabolic diseases. Ayurveda Condition: Anaemia, (2) ICD-10 Condition: E611||Iron deficiency. Ayurveda Condition: PANDUROGAH,

Registration Number: CTRI/2023/11/060271

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Anaemia among women in reproductiveage group continues to be a global public health problem with iron deficiencybeing one of the common aetiology. There has been renewed commitment towardsprevention and control of anaemia given the SDG target of reduction of anaemiaamong women of reproductive age by 2030 as a Global Nutrition Target. TheNational Health Policy of India (NHP) 2017 has also acknowledged the burden ofthis micronutrient deficiency and laid emphasis on interventions to address it.While Iron Folic acid (IFA) has been the mainstay of iron deficiency anemia (IDA)treatment since 1970â€™s, yet the poor uptake and adherence to iron and folicacid tablets has been a major challenge. There has been a growing popularity ofnatural plant-based products owing to the modest cost, low level oftechnological input and acceptance. Ayurveda offers several formulations forthe management of IDA and they have also been used in the health programsearlier. These interventions have shown encouraging responses in terms ofimproving haemoglobin levels, safety and quality of life. If proved that theycan benefit the patients with iron deficiency in a way similar to IFA, thiswill provide another choice of drug for these patients. Thus, the proposedstudy aims at assessing the efficacy and safety of Ayurvedic formulationcompared to standard care in IDA.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 3912

Inclusion Criteria

1.Non-pregnant, non-lactating women of age group 18 to 49 years 2.Haemoglobin level 8 to 10.9 gm/dl 3.Serum Ferritin less than 15 Âµg /L 4.Women who are willing to use a reliable method of contraceptive to avoid pregnancy for next 6 months.
5.Women not planning to move residence/migrate within the next 6 months.

Exclusion Criteria

1.Known case of any other forms of anaemia 2.Any acute illness within last 14 days 3.Women having attained menopause or reporting symptoms suggestive of menopause 4.Women with known case of diabetes mellitus orHbA1c more than 6.5 percent 5.Known allergy to iron and related products 6.Women with known liver and kidney disorders.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean hemoglobin at the end of intervention of 90 days among non-pregnant moderately anaemic (Hb: 8-10.9 g/dL) women of reproductive age group (18-49 years) receiving Purnarnavadi Mandura alone or Purnarnavadi Mandura in combination to Drakshavaleha, or Ferrous Sulphate and folic acid combination.	Baseline, 90 days and 180 days

Secondary Outcome Measures

Name	Time	Method
1.Change in mean hemoglobin, haematological parameters (haematocrit, MCV, MCH & MCHC) & Iron indices (TIBC, Serum Iron, transferrin saturation & serum ferritin)	at the end of 90 days of treatment & at 180 days follow up from baseline.in non-pregnant moderately anaemic (Hb:8-10.9 g/dL) women of reproductive age group (18-49 years) receiving Punarnavadi Mandura alone with those receiving Punarnavadi Mandura in combination with Drakshavaleha.

Trial Locations

Locations (8): All India Institute of Medical Sciences (AIIMS) Bhopal
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Bhopal, MADHYA PRADESH, India
All India Institute of Medical Sciences (AIIMS) Bibinagar
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Hyderabad, TELANGANA, India
All India Institute of Medical Sciences (AIIMS) Jodhpur
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Jodhpur, RAJASTHAN, India
All India Institute of Medical Sciences (AIIMS) New Delhi
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South, DELHI, India
ICMR - National Institute of Traditional Medicine (ICMR-NITM) Belagavi
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Belgaum, KARNATAKA, India
KEM Hospital Research Centre Pune
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Pune, MAHARASHTRA, India
Mahatma Gandhi Institute of Medical Sciences (MGIMS) Wardha
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Wardha, MAHARASHTRA, India
Rajendra Institute of Medical Sciences (RIMS) Ranchi
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Ranchi, JHARKHAND, India
All India Institute of Medical Sciences (AIIMS) Bhopal
🇮🇳Bhopal, MADHYA PRADESH, India
Dr Anindo Majumdar
Principal investigator
9487635186
anindo.cfm@aiimsbhopal.edu.in