Evaluation of safety and therapeutic efficacy of siddha drug "KANDAAMALAGA ILAKAM" in the treatment of Iron deficiency anaemia.
- Conditions
- patients complaints with pallor of skin and mucus membrane, fatigue, lassitude,chest discomfort, breathlessness,pica,giddiness,dizziness,angular stomatitis, pungent or bitter taste.
- Registration Number
- CTRI/2018/05/014111
- Lead Sponsor
- Ayothidoss Pandithar Hospital
- Brief Summary
It is a single non randomized open - label trial to evaluate the safety and therapeutic efficacy of kandaamalaga ilakam (internal) in Azhal veluppu noi( Iron deficiency anaemia) patients. In this trial 30 Iron deficiency anaemia patients will be recruited and the trial drug will be administered 4 gms thrice a day along with warm water for 45 days. During the study period all the study related data will be recorded and documented in a separate trial master file for each patients. During the trial period if any adverse effect will be noticed and referred to pharmacovigilance department in National institute of siddha and further management will also be given in national institute of siddha OPD and IPD. The entire trial will be monitored by the research monitoring committee of national institute of siddha. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. the outcome of this trial will be published in the Indian journal of medical research.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
Hb level less than normal range, For male:7-10gms/dl(normal:13-18gms/dl),For female:7-10gms/dl(normal:11.5-16.5), patient willing to undergo blood investigation, patient who are willing to participate in study and signing in informed consent form.
Hypertention, presence of any associated severe systemic illness (Eg.cancer, rheumatoid), Endocrine disorder( thyroid abnormality, diabetes mellitus), severe cardiac disease,Inherited defects(sickle cell Anemia, Thalassemia, Aplastic anaemia), patient not willing to give blood sample.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is mainly assessed by comparing the pre, mid and post treatment heamoglobin level of the study patient. 45 days
- Secondary Outcome Measures
Name Time Method secondary outcome is assessed by comparing the following parameters, before and after the treatment, Reduction of clinical symptoms, changes in complete blood count, changes in iron supply studies. 45 days
Trial Locations
- Locations (1)
Ayothidoss Pandithar Hospital
🇮🇳Kancheepuram, TAMIL NADU, India
Ayothidoss Pandithar Hospital🇮🇳Kancheepuram, TAMIL NADU, IndiaDrTNivethaPrincipal investigator8883176663nivetha888666@gmail.com