| CTRI Number |
CTRI/2025/02/079887 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effect of panchakarma in pureeshaja krimi in children |
|
Scientific Title of Study
|
CLINICAL STUDY TO EVALUATE THE COMBINED EFFECT OF SADYOVIRECHANA WITH KAMPILLAKA CHURNA FOLLOWED BY KATU TAILA MATRA BASTI IN THE MANAGEMENT OF PUREESHAJA KRIMI[ENTEROBIUS VERMICULARIS] IN CHILDREN |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gagana Shree S B |
| Designation |
BAMS(MD) |
| Affiliation |
|
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BM Road
Hassan Out Patient Department
of Kaumarabhritya Room 16 and 18 Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9113623144 |
| Fax |
|
| Email |
gagana0964@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayalaxmi Mallannavar |
| Designation |
ASSOCIATE PROFESSOR AND HOD |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Thanniruhalla BM Road Hassan Out Patient Department of Kaumarabhritya, Room Number 16 and 18 Hassan Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9480624829 |
| Fax |
|
| Email |
abtittu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalaxmi Mallannavar |
| Designation |
ASSOCIATE PROFESSOR AND HOD |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Thanniruhalla BM Road Hassan Out Patient Department of Kaumarabhritya, Room Number 16 and 18 Hassan Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9480624829 |
| Fax |
|
| Email |
abtittu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan
Thanniruhalla BM Road Hassan,Karnataka India 573201 |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and HospitalHassanl |
| Address |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Thanniruhalla Hassan
573201 |
| 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 Gagana Shree S B |
Sri Dharmasthala Manjunatheshwara College of ayurveda and Hospital and Hospital |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Thanniruhalla BM Road Hassan Out Patient Department of Kaumarabhritya, Room Number 16 and 18 Hassan Karnataka
Hassan
KARNATAKA |
9113623144
gagana0964@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee SDM College of Ayurveda and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:A00-B99||Certain infectious and parasitic diseases. Ayurveda Condition: PURISHAJAKRUMIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kampillaka Churna , Reference: Bhaishajya Ratnavali , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: Guda), Additional Information: After this Katu taila with Saindhava Matra basti 20-30ml once in a day is administered for period of 7days Reference is Kashyapa Samhita Krimi adhyaya |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
The Children of either gender between the age of 3-11years fulfilling diagnostic criteria of Krimi.
Children whose parents are willing to participate them in the study after giving informed parent consent.
Children who can withstand Virechana |
|
| ExclusionCriteria |
| Details |
Children Suffering from other worm infestation.
Children diagnosed from severe malnutrition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The following parameters will be assesed based on gradings.
?Guda kandu (itching in anal canal)
?Krimi darshna (worms present in stool)
?Udarashoola(Pain in abdomen)
?Agnimandya (Impaired appetite)
?Panduta (Whitish discolouration of skin)
? Vibandha(Constipation)
?Vidbheda(Diarrahea) |
?Day-0
?Day-8
?Day-15
?Day-30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The following parameters will be assesed
?Scotch tape test
?Microscopic stool examination |
?Day-0
?Day-8 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Krimiroga is a disease caused by invasion of Krimis comes under Agantuja vyadhi,as it is produced due to injury or harm caused by Krimis followed by an imbalance in the equilibrium of Doshas.Worm infestation is more common in preschool and early school age children. Parents and doctors both ignore helminthiasis since the symptoms are mild until the infection is serious. Once the condition worsen, matured eggs may enter in digestive system, where they manifest major consequences. It is difficult to treat and cure infestations once they develop and become complicated unless and until they display the problems.By seeing wide etiology and more incidence of worm infestation WHO has recommended for dewormification once in every 6 months.Even after this recurrence and prevalence’s shows parasite might have developed resistance against drugs and by frequent administration many side effects. The chikitsa for Krimi explained in classics are Nidana parivarjana, Prakriti Vigatha, Apakarshana. Hence in this Study a special treatment modility i.e Sadyovirechana with Kampillaka churna which does Apakarshana action followed by Katu taila matra basti, Katu taila by virtue of its teekshna guna makes the cyst completely destroyed, thereby interfering the lifecycle of Enterobius worm. Katu Rasa predominant with agni mahabhuta disintegrates kapha dosha which alleviates Krimi multiplying factors thus samprapti vighatana is attained.So this study is planned with Sadyovirechana f/b matrabasti for 7 days. |