Pharmacotherapeutic and physicochemical evaluation of Ayabirungarajakarpam – A Siddha drug for Paandu - Anaemia
Phase 2
Recruiting
- Conditions
- Anaemia
- Registration Number
- SLCTR/2018/035
- Lead Sponsor
- Dr. V. Elango
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 216
Inclusion Criteria
Age – 19 -60 years
Male and female
With the following cardinal signs of iron deficiency anaemia
1. Pallor
2. Palpitation
3. Extreame fatigue
4. Exertional dyspnoea
With a hemoglobin value of 7 – 11g/dL
With a serum ferritin level of<12 micrograms/L
Exclusion Criteria
Patients with
- Haemoglobin below7g/dL
- Serum ferritin below 8 micrograms/L
- Diagnosed with any other type of anaemia other than Iron deficiency anaemia.
Patients with the following complications
-Cardiac diseases
-Renal diseases
-Liver diseases
-Diabetes mellitus
-Hypertension
-Thalassaemia minor
-Bleeding disorders
-Haemoglopinapathies
-Defective absorption E.g. Patients with gastrectomy and gastrojejunostomy.
Pregnancy
Lactating mothers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The increase in haemoglobin g/dL and the serum ferritin micrograms/L per month as determined by Cyanomethoglobin method and ELISA kit respectively [15th, 30th , 48th, 62nd ,76th ,90th day from initiating therapy.]<br>
- Secondary Outcome Measures
Name Time Method Physical signs and symptoms as follows, determined by physical examination and interview of patients by investigators. <br><br>*Pallor <br><br>*Palpitation <br><br>*Effort intolerance <br><br>*Fatigue <br><br>*Breathlessness <br><br><br>These signs and symptoms will be measured using a graded point scale of 0-5 [15th, 30th, 48th, 62nd ,76th ,90th day from initiating therapy]<br>