Comparison of Chitrakadi Gutika and Dadimadi Ghrita with a Gluten-Free Diet vs. Gluten-Free Diet Alone in Managing Anemia Associated with Coeliac Disease

Efficacy of Chitrakadi Gutika and Dadimadi Ghrita along with Gluten free diet in comparison with the Gluten free diet alone in the management of Coeliac disease(Grahani) associated anaemia - A Randomized Controlled Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/074177

Enrollment

Registered

2024-09-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D509- Iron deficiency anemia, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1)Children between 5 to 12 years of age irrespective of gender. 2)Patients having ,atleast first 3 pratyatma lakshnas or more like – Atisrushtam or Ativibadhham or Atidravam malapravritti (altered bowel habits), Trushna, Arochaaka, Vairasya, Praseka, Tamaka, Shoona pada, Shoona kara, Asthi-parva ruja, Chhardi, Jwara, Louha-ama-gandhi tiktamlodgar. 3)The presence of symptoms of Pandu as described in classical Ayurvedic texts such as Panduta (pallor), Daurbalya (weakness), Shirahshoola (headache), Shrama (fatigue), and Gaurava (heaviness). 4)The patients who are diagnosed already and also newly diagnosed with coeliac disease according to ICMR ALGORITHM FOR DIAGNOSIS OF COELIAC DISEASE. 5)The patients diagnosed with coeliac disease having 8.2 to 11 gm %.. 6)Parents/Caretaker providing consent on the participant’s behalf.

Exclusion criteria

Exclusion criteria: 1)Patients with severe anaemia haemoglobin level less than 8g per dl 2)Patients unwilling or unable to undergo necessary diagnostic tests or adhere to a gluten free diet 3)Type 1 diabetes mellitus 4)Autoimmune thyroid disease 5)Genetic conditions associated with coeliac disease such as Down syndrome, Turner syndrome etc. 6)Any other systemic illness associated with coeliac disease 7)Children who are unable to comply with study procedures or follow-up visits, or whose guardians are unable to provide informed consent or comply with study requirements, may be excluded.

Design outcomes

Primary

Measure	Time frame
Improvement in coeliac disease-associated Anaemia by an increase of 2 g/dL haemoglobin in 60 days. i.e.Timeframe: at baseline, At 60 days and at 90 days.Timepoint: Improvement in coeliac disease-associated Anaemia by an increase of 2 g/dL haemoglobin in 60 days. i.e.Timeframe: at baseline, At 60 days and at 90 days.	—

Secondary

Measure	Time frame
• Improvement in quality of life • Weight gain • Improvement in sign and symptoms of Grahani Roga • Improvement in sign and symptoms of Pandu Roga i.e.Timeframe: at baseline, At 60 days and at 90 days.iTimepoint: • Improvement in quality of life • Weight gain-At every 2 weeks • Improvement in sign and symptoms of Grahani Roga • Improvement in sign and symptoms of Pandu Roga i.e.Timeframe: at baseline, At 60 days and at 90 days.i	—

Measure

Time frame

• Improvement in quality of life • Weight gain • Improvement in sign and symptoms of Grahani Roga • Improvement in sign and symptoms of Pandu Roga i.e.Timeframe: at baseline, At 60 days and at 90 days.iTimepoint: • Improvement in quality of life • Weight gain-At every 2 weeks • Improvement in sign and symptoms of Grahani Roga • Improvement in sign and symptoms of Pandu Roga i.e.Timeframe: at baseline, At 60 days and at 90 days.i

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Countries

India

Contacts

Public ContactDr Ved Prakash Vyas

All india Institute of ayurveda New delhi

vedvyas61@gmail.com9907513436

Outcome results