A study to evaluate the efficacy and safety of Shuddhi Vati in comparision with Lactulose in children suffering from chronic constipation

Phase 3

Not yet recruiting

• Conditions: Change in bowel habit,

• Registration Number: CTRI/2020/06/026163
• Lead Sponsor: National Institute Of Medical Sciences Research Jaipur

Brief Summary

**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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1-Healthy children of either gender between 2-14 years of age .
• 2-Subject in a good clinical condition as judged by the investigator based on 3-3-3-medical history and physical examination Written informed consent obtained from the subject’s parents or legally acceptable representative.

Exclusion Criteria

• 1-Age less than 2 years and more than 14 years.
• 2-Children with associated conditions like hypothyroidism, celiac disease, Malnutrition, HIV, Malignancies and Acute or Chronic illnesses will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average change in passing Frequency & consistency of stool	Visit 1: Day 0 – Baseline visit | Visit 2: Day 7 – First follow-up visit | Visit 3: One month – Second follow-up visit | Visit 4: Two month – Third follow-up visit | Visit 5: Three month– Fourth follow-up visit | Visit 6: Six Month – Fifth follow-up visit
Change in routine activity school going	Visit 1: Day 0 – Baseline visit | Visit 2: Day 7 – First follow-up visit | Visit 3: One month – Second follow-up visit | Visit 4: Two month – Third follow-up visit | Visit 5: Three month– Fourth follow-up visit | Visit 6: Six Month – Fifth follow-up visit

Secondary Outcome Measures

Name	Time	Method
Passing Blood / Pain/ Distension during trial	Find any abnormal investigation parameter during trial

Trial Locations

Locations (1)

National institute of medical science; 🇮🇳 Jaipur, RAJASTHAN, India

National institute of medical science

🇮🇳Jaipur, RAJASTHAN, India

Dr virendra kumar gupta

Principal investigator

7976406843

vk.hindustani@gmail.com