Home » Trials » SLCTR/2018/035
Pharmacotherapeutic and physicochemical evaluation of Ayabirungarajakarpam – A poly herbometallic drug for Paandu –Anaemia
-
SLCTR Registration Number
SLCTR/2018/035
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Pharmacotherapeutic and physicochemical evaluation of Ayabirungarajakarpam – A poly herbometallic drug for Paandu –Anaemia
Public Title of Trial
Pharmacotherapeutic and physicochemical evaluation of Ayabirungarajakarpam – A Siddha drug for Paandu - Anaemia
Disease or Health Condition(s) Studied
Anaemia
Scientific Acronym
None
Public Acronym
ABK (Ayabirungarajakarpam capsule)
Brief title
Evaluation of Ayabirungarajakarpam for Anaemia
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
ERC/2017/56 : Rajarata University
What is the research question being addressed?
What are the physicochemical properties and pharmacotherapeutic effects of Ayabirungarajakarpam on Paandu – Iron Deficiency Anaemia?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Treatment
Study Phase
Phase 2-3
Intervention(s) planned
The study will be done at the Outpatient Department (OPD) of Teaching Hospital of Siddhamedicine,Trincomalee
This is a single arm, non randomized study and patients with classical clinical features of iron deficiency anaemia will be selected by screening through case proforma and confirmed by hemoglobin and peripheral blood film. Patient will receive one Ayabirungarajakarpam (ABK) capsule 500 mg orally twice a day after morning and night meal with 200 ml of lime juice for consecutive 48 days from the date of initiating therapy. A period of non-drug therapy will follow for 42 days starting from the 49th day of treatment with investigational drug. Normal diet will be advised to all cases according to age. Patients will be asked to report on 15th , 30th, 48th, 62nd, 76th, and 90th day from initiating therapy to record findings.
The composition of ABK capsule includes,
1.Ayathool –(Ferrum)-140 g
2.Manduram –Ferroso ferric oxide -210 g
3.Karisalai juice –(Wedelia chinensis) -1.3 L
4.Elumichai juice –(Citrus limon) -1.3 L
The study will be a single arm study without masking
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
Primary outcome(s)
|
1.
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. ] |
Secondary outcome(s)
|
1.
Physical signs and symptoms as follows, determined by physical examination and interview of patients by investigators. 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 ] |
Target number/sample size
216
Countries of recruitment
Sri Lanka
Anticipated start date
2018-11-01
Anticipated end date
2019-03-30
Date of first enrollment
2018-11-01
Date of study completion
Recruitment status
Recruiting
Funding source
National Centre for Advance Studies, Ministry of Higher Education, Sri Lanka
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-06-25
Approval number
ERC/2017/56
Details of Ethics Review Committee
| Name: | 9. Ethics Review Committee of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka. |
| Institutional Address: | 2nd Floor, Para-clinical Building Faculty of Medicine and Allied Sciences Rajarata University of Sri Lanka Saliyapura, Sri Lanka |
| Telephone: | +94 252053633 |
| Email: | ethicsreviewcommittee@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr.N.Varnakulendran
Senior lecturer
Trincomalee campus,
Eastern University of Sri Lanka,
Konesapuri,
Nilaveli,
Trincomalee
Tel: 0262227812
Mob: 0718229630
Fax: 0262227411
drvarnan@gmail.com
Contact Person for Public Queries
Dr.N.Varnakulendren
Senior lecturer
Trincomalee campus,
Eastern University of Sri Lanka,
Konesapuri,
Nilaveli,
Trincomalee
Tel: 0262227812
Mob: 0718229630
Fax: 0262227411
drvarnan@gmail.com
Primary study sponsor/organization
Dr. V. Elango
Associate Professor
Department of Siddha medicine,
Tamil university,
Thanjavur
Tel: 00919843725592
drelango@gmail.com
Secondary study sponsor (If any)
Dr.V. Shiyamala
Medical Officer Incharge
Teaching Hospital of Siddha medicne,
Konesapuri,
Trincomalee
Tel: 0262051222
Fax: 0262051222
drshiyavarna@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
