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CTRI Number  CTRI/2020/12/030006 [Registered on: 23/12/2020] Trial Registered Prospectively
Last Modified On: 15/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to evaluate Constipation Formulation for treatment of Constipation in Children 
Scientific Title of Study   Evaluation of efficacy and safety of Constipation Formulation in the management of Constipation in Children: A prospective, randomised, double-blind, single center, placebo-controlled, interventional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SBS/AWPL/LAX/07203 Version 1.0 Date: 30th July 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravi Kumar Taduri 
Designation  Paediatrician 
Affiliation  Kakatiya Hospital 
Address  Department of Paediatrics, Kakaitya Hospital, Road No.2, P&T Colony, Medipally, Uppal, Hyderabad

Hyderabad
TELANGANA
500039
India 
Phone  8019806283  
Fax    
Email  taduriravi.kh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr C M Reddy 
Designation  Chief Scientific Officer 
Affiliation  Amitojas Wellness Private Limited 
Address  #3-100-55/739, Block-A,2nd Floor, JK Arcade Jayaberi Park, Kompally, Hyderabad

Hyderabad
TELANGANA
500014
India 
Phone  8885324455  
Fax    
Email  cso@amitojas.com  
 
Details of Contact Person
Public Query  
Name  Mr Kamal Kammili 
Designation  Director - Operations 
Affiliation  Sanjeevani Bio Services Private Limited 
Address  3rd Floor, Plot No. 28B, Raghavendra Colony, Kondapur, Hyderabad

Hyderabad
TELANGANA
500084
India 
Phone  04048593559  
Fax    
Email  kamal.kammili@sanjeevanibio.com  
 
Source of Monetary or Material Support  
Amitojas Wellness Private Limited 
 
Primary Sponsor  
Name  Amitojas Wellness Private Limited 
Address  2nd Floor, JK Arcade Jayaberi Park, Kompally, Hyderabad, Telangana – 500014, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravi Kumar Taduri  Kakatiya Hospital  Department of Paediatrics, Kakaitya Hospital, Road No.2, P&T Colony, Medipally, Uppal, Hyderabad
Hyderabad
TELANGANA 		 8019806283

taduriravi.kh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kakatiya Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K590||Constipation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Constipation Relief Formulation  The investigational product, Constipation Relief Formulation Sachet is a nutraceutical product, formulated as an edible powder which has Psyllium Husk powder, Apple fruit powder, Inulin (Chicory Root Powder), Calcium Sennosides, Bacillus coagulans, Zinc ( as Zinc Sulphate. Once sachet of study treatment is to be administered orally once daily after dinner for 14 days. 
Comparator Agent  Placebo  The placebo sachets are similar to the on Constipation Relief Sachets excpet they do not contain Active Ingredients. Once sachet of study treatment is to be administered orally once daily after dinner for 14 days. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1. Male and female children aged ≥3 to ≤16 years.
2. Duration of constipation more than 4 weeks.
3. Presence of ≥2 of the following:
a. defecation frequency ≤2 times per week
b. faecal incontinence ≥1 time per week
c. history of excessive stool retention
d. history of painful or hard bowel movements
e. presence of a large mass in the rectum or on per abdomen examination
f. history of large-diameter stools that may obstruct the toilet (if information available)
4. Children willing to provide informed assent if applicable.
5. Child’s parent/guardian/legally acceptable representative willing to provide informed written consent. 
 
ExclusionCriteria 
Details  1. Presence of other organic disorders which might be cause of constipation.
2. Children suffering from irritable bowel syndrome
3. Children with hormonal diseases
4. Children who have received other treatments for constipation in the past 48 hours.
5. Children who are planned to be treated through disimpaction.
6. Current or past history of a serious illness including, seizures, major psychiatric illness, structural brain disease, liver or kidney failure, organ transplantation, rheumatoid arthritis, uncontrolled hypertension, uncontrolled diabetes or malignancy, cardiovascular event in the last three months.
7. Allergy or sensitivity to any of the ingredients in the study treatment.
8. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly.
9. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Stool frequency documented in the CRF at baseline, day 7 and day 14 (values and change from baseline - within the group and between the groups comparisons)  baseline, day 7 and day 14  
 
Secondary Outcome  
Outcome  TimePoints 
Stool consistency documented in the CRF baseline, day 7 and day 14 (values within the group and between the groups comparisons)  baseline, day 7 and day 14  
Symptomatic change in fecal incontinence documented in the CRF baseline, day 7 and day 14 (values within the group and between the groups comparisons)  baseline, day 7 and day 14 
Symptomatic change in abdominal pain documented in the CRF baseline, day 7 and day 14 (values within the group and between the groups comparisons)  baseline, day 7 and day 14 
Weight gained post treatment documented in the CRF baseline, day 7 and day 14 (values and change from baseline - within the group and between the groups comparisons)  baseline, day 7 and day 14 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   30/12/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Constipation is one of the most common gastrointestinal problem, affecting up to 30% of the children, and have a significant impact on health care use, resulting in tremendous social and economic burden. It is a common paediatric healthcare problem worldwide, with reported prevalence ranging from 0.7 and 29.6 %. It is characterized by infrequent bowel movements or difficulty with evacuation of stools and is associated various symptoms including hard and/or large stools, painful defecation, and faecal incontinence, and is often accompanied by abdominal pain.
The prevalence of constipation including infants and adolescents ranges between 10% and 23% in North and South America, while in Europe (only including children) figures between 0.7% and 12% are reported. In Asia, the prevalence is estimated between 0.5% and 29.6%. The prevalence varies according to age groups. The peak incidence of constipation occurs between 2 and 4 years of age. Causes of constipation can be categorized as primary (slow transit or outlet obstruction) or secondary causes. Secondary causes can include simple dehydration or inadequate fluid intake, metabolic disturbances, medications, neurological disorders, failure to respond to urge to defecate, myopathic disorders and structural abnormalities.
There are a wide variety of prevention and treatment strategies, which can significantly improve the quality of life in children. However, there is no data concerning the maximum dosage, course of treatment and long-term adverse effects of the administered medications in treating childhood constipation, therefore, the current treatment is symptomatic and largely dependent on clinical experience of health care providers. Nowadays, due to the importance of safety and desire for lowered costs, there is greater attention placed on nutraceutical product as therapies. Nutraceutical products have been demonstrated to be consistently reliable in treatment and prevention of various diseases. They have also recently become a focus of researchers in the development and preparation of new drugs. Particularly, their active ingredients can have antioxidant activities and therapeutic effects and have been used in the treatment of many diseases, including and especially constipation in children. Therefore, the objective of the current study is to determine the effect of nutraceuticals on management of constipation in children. 
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