| CTRI Number |
CTRI/2019/03/018252 [Registered on: 25/03/2019] Trial Registered Prospectively |
| Last Modified On: |
25/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of Yavani churna and Kampillaka churna in the treatment of worm infestation in age group 3-6 yeras. |
|
Scientific Title of Study
|
A standard controlled clinical trial of Yavani churna and Kampillaka churna in the management of Pureeshaja krimi 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 |
Dr Sanket Prakash Khedekar |
| Designation |
PG Student |
| Affiliation |
College of ayurved and research centre Akurdi Pune |
| Address |
PDEAs College of Ayurved and Research centre Akurdi Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9665006787 |
| Fax |
|
| Email |
sanketkhedekar75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Sanjay Deodas |
| Designation |
HOD And Guide |
| Affiliation |
College of ayurved and research centre Akurdi Pune |
| Address |
PDEAs College of Ayurved and Research centre Akurdi Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanket Prakash Khedekar |
| Designation |
PG Student |
| Affiliation |
College of ayurved and research centre Akurdi Pune |
| Address |
PDEAs College of Ayurved and Research centre Akurdi Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9665006787 |
| Fax |
|
| Email |
sanketkhedekar75@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved And Research centre 3rd floor kaumarbhritya department Akurdi pradhikaran sector no25 Pune 44 |
|
|
Primary Sponsor
|
| Name |
CARC Nigdi Pune |
| Address |
Nigdi pradhikaran Sec 25 Akurdi Pune |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Sanket Prakash Khedekar |
Ayurved Rugnalaya and Sterling multi speciality Hospital Nigdi |
Vitthal Rukhamini road sector 27 Nigdi Pradhikaran pune 411044 Name of OPD- Kaumarbhritya no of OPD-118 on ground floor Pune MAHARASHTRA
Pune
MAHARASHTRA |
9665006787
sanketkhedekar75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institunationl ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
kampillaka churna |
kampillaka churna is prepared by churna kalpana and will be given orally to the children in between 3-6 years of age.the dose is calculated by clarks formula which is 85mg/kg/dayand will be given twice a day before meal which includes follow up on 7th,14,21st,28day. |
| Intervention |
Yavani churna |
Yavani churna is prepared by churna kalpana and will be given orally to the children in between 3-6 years of age.the dose is calculated by clarks formula which is 75mg/kg/dayand will be given twice a day before meal which includes follow up on 7th,14,21st,28day. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient between the age group 3-6 years
2.history of krimipatan
3.Exihibiting symptoms of worm infestation such as
agnimandya,panduta,krushta,rukshata,Gudkandu,Udarshool,Atisara(asthang hridaya 14/56) |
|
| ExclusionCriteria |
| Details |
1.Acute symptoms like acute abdominal pain,severe diarrheoa,severe vomiting,high grade fever.
2.Any congenital gastrointestinal anamolies like intestinal obstruction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the role of Yavani churna and kampillaka churna in the management of pureeshaja krimi. |
28 days with follow up on 7th,14th,21st,28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the effect of Yavani churna
2.To study the effect of kampillaka churna.
3.To observe the adverse effect of Yavani churna and kampillaka churna ,if any |
28 days. |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/03/2019 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Helminthiasis is the most common peditric complaint world wide.most of world’s population is infected with one or more most common parasites like round worms,hook worms and whipworms. The complaints towards the infestation of intestinal worms come with greater incidence in pediatric practice. Helminthiasis is ignored by parents because of less severity of symptoms till the infection becomes severe. and many anti helminthic drugs have many adverse effects like diarrhoea,nausea,abdominal pain,dizziness,headache,fever,jaundice. However yavani churna is deepniya,pachniya which increases apetite also it is kaphavataashamaka and krimighna.and kampillaka also has krimighna property.Hence these drugs are selected in this study |