Clinical study of Darvyadi Granules in Iron Deficiency Anaemia.

Phase 1

Not yet recruiting

Conditions: Other iron deficiency anemias, (2) ICD-10 Condition: D508||Other iron deficiency anemias,

Registration Number: CTRI/2020/04/024459

Lead Sponsor: Parul University

Brief Summary: Anaemia is a major public health concern in India and20% of the population suffer globally. The major cause of the disease isrecognized as Iron deficiency. In the present project objective of the study willbe to evaluate the efficacy of Darvyadi Granules in Iron deficiency anaemia inhuman subjects. In Panduroga Rogadhikaraof Charak Samhita, Darvyadi churna is mentioned which is indicated in YakritVikara and Panduroga. It includes 9 ingradients namely Triphala, Trikatu,Darvi, Vidanga and Lauha Bhasma. In the present work this formulation ismodified to Darvyadi Granules for better acceptability and palatability to thepatients. Darvyadi Granules will be prepared in the teaching Pharmacy, PIAR.Raw materials and final product quality assessment will be done in recognizedanalytical laboratories.

Itis an open labeled single centric clinical trial.As it isa pilot study, sample size of 30 subjects irrespective of race, gender,occupation, socio economic status will be considered. The subjective parameterssuch as Pallor,Shortnessof Breath, Fatigue, Palpitation, and Dizziness will be assessed. Hb%, Complete Blood Count, SerumFerritin, Total Iron Binding Capacityand PeripheralSmear of the patient will be investigated to observe the effect. Patients willbe screened for the study based on subjective parameters Hb% and MCV. Patientswill be on treatment with trial drug for a period of 3 months and observationwill be done on every 15th day. The duration of the project will be18 months which includes preparation of the medicine, screening of the patientsand treatment period of 90 days. The observations will be statisticallyanalyzed and documented.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patient fulfilling screening parameters. Age limit 18-70 years irrespective of religion, socioeconomic, marital status and gender Hb%.
Between 8 gm% and 11gm%.

Exclusion Criteria

Anemia other than Iron deficiency anemia, Sickle cell anemia.
Patients suffering from systemic disorders like tuberculosis, HIV, Leprosy and any malignancies.
Pregnant and Lactating Woman.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.This particular form of medicine is not available and is also cost effective.	1 year
1.New modifieddosage form of Darvyadi Churna will be introducedin clinical practice which will be suitable for all age groups from paediatric to Geriatric.	1 year
3.The study may throw up effective remedy for treating Iron Deficiency Anaemia thus benefiting the population suffering from the disease.	1 year

Secondary Outcome Measures

Name	Time	Method
2.This particular form of medicine is not available and is also cost effective.	3.The study may throw up effective remedy for treating Iron Deficiency Anaemia thus benefiting the population suffering from the disease.

Trial Locations

Locations (1): Parul Institute of Ayurved and Research
🇮🇳
Vadodara, GUJARAT, India
Parul Institute of Ayurved and Research
🇮🇳Vadodara, GUJARAT, India
Dr Anitha H
Principal investigator
9739624874
docvaishnavi@gmail.com