Pharmaceutical Analytical and Interventional study of Darvyadi Granules in Iron Deficiency Anaemia-A Pilot Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Parul University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1.New modifieddosage form of Darvyadi Churna will be introducedin clinical practice which will be suitable for all age groups from paediatric to Geriatric.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
1.New modifieddosage form of Darvyadi Churna will be introducedin clinical practice which will be suitable for all age groups from paediatric to Geriatric.
Time Frame: 1 year
3.The study may throw up effective remedy for treating Iron Deficiency Anaemia thus benefiting the population suffering from the disease.
Time Frame: 1 year
2.This particular form of medicine is not available and is also cost effective.
Time Frame: 1 year
Secondary Outcomes
- 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.)