blood level can be increased on taking an Ayurvedic Formulation "Vidangadi Lauha" in Girls Of Age Group 10-16 Years.

Phase 1/2

Completed

• Conditions: Other iron deficiency anemias,

• Registration Number: CTRI/2018/06/014376
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

RESEARCH QUESTION

What is the efficacy of the oral administration of Vidangadi Lauha syrup/malt in managing Pandu Roga (IDA) in comparison with that of Iron and Folic acid in adolescent girls?

HYPOTHESIS

Blood haemoglobin level is improved and sign and symptoms of Pandu Roga (IDA) are reduced in adolescent girls who receive daily Vidangadi Lauha syrup/malt for a period of 3 months with the dose of 10ml OD, compared with the adolescent girls who receive Iron and Folic acid with the dose of iron-60mg and folic acid-400microgram/day for same period of time.

Null hypothesis-

H0: In the proposed clinical trial null hypothesis is that the efficacy of Vidanagadi Lauha is no better, on average in comparison with the Iron and Folic acid.

Alternate hypothesis-

H1: The alternative hypothesis is that the efficacy of Vidangadi Lauha is better in comparison with that of Iron and Folic acid.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-07
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Female patients between the age group of 10-16 years.
• Patients presenting clinical sign and symptoms of Pandu Roga (IDA).
• Patients with mild to moderate anaemia (haemoglobin level from 11g/dl to 8g/dl).
• Patients/Parents giving consent to participate in the study.

Exclusion Criteria

• Females below 10 years and above 16 years of age.
• Patients with severe anaemia (haemoglobin level <8g/dl) requiring hospitalization and BT, patients of T.B, D.M, heart diseases, liver diseases and other chronic systemic disorders.
• Conditions like menorrhagia, piles, fissures and other haemorrhagic conditions.
• Anaemia in case of defective absorption due to gastrectomy, sprue syndrome.
• Any other systemic disease wherein anaemia is one among the presenting complaints.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Haemoglobin g/dl	3 Months

Secondary Outcome Measures

Name	Time	Method
Reduction in signs and symptoms of Pandu Roga (IDA).	Improvement in CBC, Serum Iron, Serum Ferritin and TIBC.

Trial Locations

Locations (1)

All India Institute Of Ayurveda; 🇮🇳 Delhi, DELHI, India

All India Institute Of Ayurveda

🇮🇳Delhi, DELHI, India

Dr Monika

Principal investigator

9711728156

ayurmonika@gmail.com