Randomised Controlled Clinical Trial To Evaluate The Efficacy Of Vidangadi Yavagu In The Management Of Krimi With Special Reference To Abhyantar Krimi

Title :-

RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF VIDANGADI YAVAGU IN THE MANAGEMENT OF KRIMI W.S.R. TO ABHYANTAR KRIMI.

Primary Objectives :-

To study the effect of Vidangadi Yavagu in the management of Krimi w.s.r. to Abhyantara Krimi.

Secondary Objectives :-

1. To study the Aetiopathogenesis of Krimi from Ayurvedic classics and Ascariasis Lumbricoides from modern texts.

2. To assess the effect of Vidangadi Yavagu in the management of Krimi w.s.r. to Abhyantara Krimi.

Methodology :-

Study Setting :

All the clinical studies will be conducted on the patients of Krimi by attending OPD of Kaumarbhritya department.

Study Population :

All the diagnosed cases of Krimi from opd of Kaumarbhritya department.

Study type :

Randomized Controlled Clinical trial.

Study design :

Open randomized controlled clinical study

Study will include 80 diagnosed patients of Krimi

Informed written consent of Parents will be taken then divided in two groups.

Case data will be recorded

Randomization and allocation

Group allocation in Group A is trial Group and Group B is control group. Vidangadi Yavagu will be given to Group A and Tab Albendazole will be given to  group B.

Assessment of Subjective & Objective parameters

Follow up on 0th, 7th, 14th day of treatment, Observation will be noted.

Data analysis will be done by using appropriate statistical test.

INCLUSION CRITERIA

1. Age group between 3 to 12 years.

2. Patients irrespective of their sex, religion & economic status.

3. Patients having 2 or more sign and symptoms of krimi viz. Udarshool, gudakandu, bhaktadwesha, jwara, chhardi.

4.Subject and parent/ legal guardian willing to provide written infomed consent/ assent and abide the trial procedures.

EXCLUSION CRITERIA

1. Patients below age 3 and above 12 year.

2. Patients with congenital abnormalities.

3. Patients with nematodes infestation with obstruction, pulmonary eosinophilia, cholecysitis, pancreatitis, malignancies, STD’s disease.

4. Any other systemic diseases which interfere with longterm treatment.

WITHDRAWAL CRITERIA

1. Children fails to report for follow up.

2. Patient willing to discontinue during trial treatment.

3. Patient not giving written consent form.