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CTRI Number  CTRI/2014/09/005030 [Registered on: 17/09/2014] Trial Registered Retrospectively
Last Modified On: 10/09/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   Clinical study on Keeri Noi (intestinal worm infestation ) in children 
Scientific Title of Study   A Preclinical & Clinical evaluation on Keeri Poochi Nei in the treatment of Keeri noi in children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrNBArchana 
Designation  PG Scholar M.D. (Siddha ) 
Affiliation  National Institute of Siddha  
Address  National Institute of Siddha , Tambaram Sanatorium , Chennai .

Chennai
TAMIL NADU
600047
India 
Phone    
Fax    
Email  dr.arche23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrNBArchana 
Designation  PG Scholar M.D. (Siddha ) 
Affiliation  National Institute of Siddha  
Address  National Institute of Siddha , Tambaram Sanatorium , Chennai .

Chennai
TAMIL NADU
600047
India 
Phone    
Fax    
Email  dr.arche23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrMMeenakshi sundaram 
Designation  Asst professor Department of Kuzhanthai maruthuvam 
Affiliation  National Institute of Siddha  
Address  National Institute of Siddha , Tambaram Sanatorium , Chennai .

Chennai
TAMIL NADU
600047
India 
Phone    
Fax    
Email  mmssiddha@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha. Tambaram sanatorium Chennai 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Department of Kuzhandhai Maruthuvam National Institute of Siddha, Tambaram Sanatorium, Chennai-47  
Type of Sponsor  Research institution and hospital 
 
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 
Archana  National Institute of Siddha,   Department of Kuzhandhai Maruthuvam National Institute of Siddha, Tambaram Sanatorium, Chennai-47
Chennai
TAMIL NADU 
9791133448

dr.arche23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Positive investigation of stools. History of passing worms in the stools. loss of appetite . Presence of peri anal itching . Pain around the umbilicus. Teeth grinding during sleep (Bruxium ) ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KEERI POOCHI NEI   KEERI POOCHI NEI a polyherbal drug given for 3 days in hot water 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Positive investigation of Stool examination with ova and cyst of worms.
Having complaints of loss of appetite .
Presence of peri anal itching .
Pain around the umbilicus.
Teeth grinding during sleep (Bruxium )
History of passing worms in the stools.
Willing to give both blood and motion specimen for investigation, when required

 
 
ExclusionCriteria 
Details  Children below 6 yrs age
Patient with chronic diseases like primary complex, chronic renal failure etc.,
Patients not willing to give blood and motion sample for investigation
Enteric fever
Amoebiasis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Absence of ova cyst in stool examination.
Improvement to be noticed in clinical symptoms. 
2-3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Safety profile of Keeri poochi nei
 
1-2 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   06/08/2014 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

One third of the world’s population is infected with one or more species of intestinal helminth,1 and public health specialists are concerned that these infections impair children’s growth and development. Studies have shown associations between helminth infection and undernutrition, iron deficiency anaemia, stunted growth, poor school attendance, and poor performance in cognition tests.(1) In India several studies have been carried out on the health status of school age  children.These have largely been quantitative and reported morbidity included malnutrition (10.0 – 98.0 % ) worm infestation (2.0 –30.0 %) and anemia ( 4.0 – 15.0 %)  (2) A comparitive study of intestinal parasites prevalent among children living in rural and urban settings in and around Chennai reveals that the overall prevalence of intestinal parsites under  the rural location was 91 % and in contrast under urban setting was 33 % (3) Medicinal plants have served through ages, as a constant source of medicaments for the exposure of a variety of diseases. The history of herbal medicine is almost as old as human civilization. The plants are known to provide a rich source of botanical anthelmintics, antibacterials and insecticides (4) Anthelmintic that are obtained from the natural resources may play an important role in the treatment of worm infection with less side effects (5) Lack of personal hygiene, contaminated food and poor socio-economic environmental sanitation all together contributes for the occurrence of the intestinal worm infestation. High incidence of cases was noted in the age ranging between 6 – 12 years (62%).(6). This is because school going children are more prone to this condition due to pica, unhygienic food habit and contaminated water intake and also due to over crowded situations (7) Ascariasis is caused in children,by Ascariasis lumbricoides characterized by              Abdominal pain , Loss of appetite , Perianal itching . The test drug Keeri poochi nei is chosen from the Non Sastric formulation for Keeri noi which may be correlated with that of Ascariasis. As the individual drugs ( Nigella sativa, piccorhiza korra, coccus nucifera ) of the current study have their anthelmintic activity as per our Siddha literature and recent studies on the drug, which triggered us for the study  to bring out the efficacy of the drug to the effective treatment of Keeri Noi. 

 
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