| CTRI Number |
CTRI/2024/12/077575 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect Of Kampillaka Churna With Gud In Roundworm Infestation in School going Children. |
|
Scientific Title of Study
|
A Phytochemical and clinical study of Kampillak (Mallotus phillippensis Muell Arg) with Gud in Gandupada krimi with special reference to Ascaris lumbricoides. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mangal Ramesh Rathod |
| Designation |
Post Graduate Resident |
| Affiliation |
APMS Ayurved Mahavidyalaya Sion |
| Address |
Department of Dravyaguna APMs Ayurved Mahavidyalaya Sion near sion railway station Mumbai India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8208495409 |
| Fax |
|
| Email |
mangalrathod802@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPritam Chindarkar |
| Designation |
Professor |
| Affiliation |
APMS Ayurved Mahavidyalaya Sion |
| Address |
Department of Dravyaguna
APMS Ayurved Mahavidyalaya Sion near sion railway station MumbaiIndia
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7045320847 |
| Fax |
|
| Email |
drpritam_chindarkar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPritam Chindarkar |
| Designation |
Professor |
| Affiliation |
APMS Ayurved Mahavidyalaya Sion |
| Address |
Department of Dravyaguna
APMS Ayurved Mahavidyalaya Sion near sion railway station Mumbai,India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7045320847 |
| Fax |
|
| Email |
drpritam_chindarkar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| APMs Seth R. V. Ayurved Rugnalaya and Ayurved Mahavidyalaya near Sion railway station Sion East Mumbai 400022 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Mangal Ramesh Rathod |
| Address |
APMs Ayurved Mahavidyalaya Sion near sion railway station Mumbai 400022 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Mangal Ramesh Rathod |
Ayurved Prasarak Mandal R V Ayurvedic Rugnalaya |
OPD NO.2 Balrog , Ayurved Prasarak Mandal Ayurved Mahavidyalaya near sion railway station Sion East Mumbai 400022
Mumbai
MAHARASHTRA |
8208495409
mangalrathod802@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B779||Ascariasis, unspecified. Ayurveda Condition: GANDUPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kampillaka, Reference: Bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: gud), Additional Information: Dose in children calculated by Youngs formula
5 year-300 mg
6 year -333 mg
7 year-368mg
10 year-454 mg
12 year-500 mg
15year- 555mg
Dose of gud -5 gm for every patient |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of krimirog
with positive stool routine microscopy for ascaris lumbricoides |
|
| ExclusionCriteria |
| Details |
Patient who has taken albendazole for last 6 months
Those with complication of disease
Patient with severe systematic illness and immuno compromised person
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stool routine microscopy examination
CBC [If Necessary]
stool culture [ If Necessary] |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Jwara (Fever)
2.Udarshool (Abdominal Pain)
3.Vivarnata (Discolouration of skin)
4.Bhaktadwesha (Loss of Appetite)
5.Chardi(Vomiting)
|
14 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/12/2024 |
| 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="6"
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
|
Helminth is a general term meaning worms . there are many different types of intestinal worms roundworms is commonly found in pre-school and school aged children . Many drugs are available to treat krimi but they are getting resistance just like modern medicines , when used frequently symptoms of krimi resemble with helminthic infection .available modern treatment for helminthic infection gives symptomatic relief but does not cure the cause . Modern medicines only kills adult parasitic worms and their larvae . Kampillaka (Mallotus phillppensis Muell Arg ) poses both the properties like APAKARSANA ( Removal of parasite from the body by mechanical and therapeutic measures ) and PRAKUTI-VIGHAT ( Creation of such environment in gastrointestinal which hinders growth and development of krimi at habitat . so I have decided to study of Kampillaka (Mallotus phillppensis Muell Arg ) in gandupada krimi with special reference to Ascaris lumbricoides. |