A prospective, comparative, randomized trial to evaluate the clinical efficacy and safety of Shudhhi Vati (ayurvedic drug) in comparison with Lactulose (allopathic drug) in children suffering from chronic constipation

This will be A prospective, comparative, randomized trial to evaluate the clinical efficacy and safety of Shudhhi Vati (ayurvedic drug) in comparison with Lactulose (allopathic drug) in children suffering from chronic constipation.

**AIM AND OBJECTIVES:**1. Increase quality of life & daily activity of children. 2. Decrease episodes of constipation.

MATERIAL AND METHODS:

**STUDY DESIGN:**A Prospective, Randomized, Two arm, parallel, hospital based, non –inferiority phase III/ IV clinical study

STUDY AREA: OPD & IPD patients of NIMS hospital in department of Pediatrics

SAMPLE SIZE AND SAMPLING TECHNIQUE:

A total of 100 patients to be selected by Odd-Even Randomized sampling technique.(50 Cases in each arm)

STUDY POPULATION: Children between age 2-14 years.

STUDY PERIOD: Six Month for a case.

TIME FRAME: One Year

STASTICAL ANALYSIS: All Intragroup datas will be qualitative which will be calculated with Chi- Square test and Inter group datas will be quantitative where Unpare T test will be applicable, all datas will be plotted on SPSS 2.0 softwere

INCLUSION CRITERIA:

•      Healthy children of either gender between 2-14 years of age .

•      Subject in a good clinical condition as judged by the investigator  based on medical history and physical examination

•      Written informed consent obtained from the subject’s parents or legally acceptable representative

EXCLUSION CRITERIA:

•      Age less than 2 years and more than 14 years.

•      Children with associated conditions like hypothyroidism, celiac disease, Malnutrition, HIV, Malignancies and Acute or Chronic illnesses will be excluded.

METHODOLOGY: After enrollment of patient with all inclusion criteria , a odd even randamization will be applicable to the patient and two groups will be made onthe basis of drug intervention as allopathic and ayurvedic drug. After complettee treatment and follow up all results will be record.

Questionnaire for all patient:

1- Frequency to passing stool ?

a) Daily       b) 2-4 days c) 5-7 days d) >7 Days

2-Consistency of stool ?

a) Liquid    b) Semi solid c) Solid     d) Hard

3- Feeling pain during passing stool ?          Yes/No

4- Bleeding during passing stool  ?    Yes/No

5-Distension of abdomen ?                          Yes/No

INVESTIGATIONS

•      At First Visit:

Blood investigations to rule out other associated disease ( If required)

CBC, LFT, Free T4, TSH, Ttg-IgA, HIV    serology, Serum Electrolyte

•      In Follow up Visit:

Serum electrolyte and others if required