Home » Trials » SLCTR/2018/035


Pharmacotherapeutic and physicochemical evaluation of Ayabirungarajakarpam – A poly herbometallic drug for Paandu –Anaemia

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SLCTR Registration Number

SLCTR/2018/035


Date of Registration

29 Oct 2018

The date of last modification

Jan 28, 2019



Application Summary


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


Trial Details


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.
    *Pallor
    *Palpitation
    *Effort intolerance
    *Fatigue
    *Breathlessness

    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



State of Ethics Review Approval


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 & Sponsor Information


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

Trial Completion details


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