| 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
|
|
|
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
|
|
|
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. |