| CTRI Number |
CTRI/2025/08/093628 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study To Test The Effectiveness Of Vidangadi Yavagu In Treating Worm Infestation In childrens |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial To Evaluate The Efficacy Of Vidangadi Yavagu In The Management Of Krimi With Special Reference To Abhyantar Krimi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Laxman Pawaskar |
| Designation |
PG Scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Post Graduate Research Center, Ground Floor Balrog Department, Shendri Mal Road,Gadhinglaj
Kolhapur
Maharashtra
416502
India
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9657415747 |
| Fax |
|
| Email |
ankitap1911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankita Laxman Pawaskar |
| Designation |
PG Scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Post Graduate Research Center, Ground Floor Balrog Department, Shendri Mal Road,Gadhinglaj
Kolhapur
Maharashtra
416502
India
MAHARASHTRA
416502
India |
| Phone |
9657415747 |
| Fax |
|
| Email |
ankitap1911@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dheeraj Shankar Shinde |
| Designation |
Professor |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Post Graduate Research Center, Ground Floor Balrog Department, Shendri Mal Road,Gadhinglaj
Kolhapur
Maharashtra
416502
India
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9860122355 |
| Fax |
|
| Email |
dr.dheeraj26@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic Mahavidyalaya , Post Graduate Research Center, Shendri Mal Road, Gadhinglaj
Dist- Kolhapur
State- Maharashtra
416502 |
|
|
Primary Sponsor
|
| Name |
Dr Ankita Laxman Pawaskar |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya , Post Graduate Research Center,Room No 2, Kaumarbhritya Department Shendri Mal Road, Gadhinglaj Dist- Kolhapur State- Maharashtra 416502
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Ankita Laxman Pawaskar |
Late Kedari Redekar Dharmaday Rugnalaya, Gadhinglaj |
Room no 2, Ground Floor , Kaumarbhritya Department,Gadhinglaj ,Dist- Kolhapur State- Maharashtra 416502
India
Kolhapur
MAHARASHTRA |
9657415747
ankitap1911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Of LKR Ayurvedic Mahavidyalaya Gadhinglaj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B77||Ascariasis. Ayurveda Condition: PURISHAJAKRUMIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Albendazole | Albendazole Is Standard Control Drug
Form -Tablet
Route- Oral
Dose- 400 mg | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi Yavagu, Reference: Chakradatta 7/8, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: suvarchika), Additional Information: -Takrasiddha yavagu |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 3 to 12 years.
2.Patient irrespective of their sex, religion & economic status.
3.Patient having 2 or more signs and symptoms of krimi viz.Udarshool, gudakandu, bhaktadwesha, jwara, chhardi.
4. Subject and parent/legal guardian willing to provide written informed consent/assent the trial procedures. |
|
| ExclusionCriteria |
| Details |
1)Below age 3 and above 12 year.
2)Patients with congenital abnormalities. 3)Patients with nematodes infestation with obstruction, pulmonary eosinophilia, cholecysitis, pancreatitis, malignancies, STD’s disease.
4)Any other systemic diseases which interfere with long
term treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study efficacy of vidangadi yavagu in the management of krimi with special reference to Abhyantar krimi in children |
Initial assesment at 0 day
Follow up 7th, 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the etiopathogenesis of krimi from ayurvedic classics and ascariasis lumbricoides from modern texts.
To assess the effect of Vidangadi yavagu in management of krimi with special reference to krimi. |
Initial assesment at 0 day
Follow up 7th, 14th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
21/09/2025 |
| 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="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
|
Title :- RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF VIDANGADI YAVAGU IN THE MANAGEMENT OF KRIMI W.S.R. TO ABHYANTAR KRIMI.
Primary Objectives :- To study the effect of Vidangadi Yavagu in the management of Krimi w.s.r. to Abhyantara Krimi.
Secondary Objectives :- 1. To study the Aetiopathogenesis of Krimi from Ayurvedic classics and Ascariasis Lumbricoides from modern texts. 2. To assess the effect of Vidangadi Yavagu in the management of Krimi w.s.r. to Abhyantara Krimi.
Methodology :-
Study Setting : All the clinical studies will be conducted on the patients of Krimi by attending OPD of Kaumarbhritya department.
Study Population : All the diagnosed cases of Krimi from opd of Kaumarbhritya department.
Study type : Randomized Controlled Clinical trial.
Study design :
Open randomized controlled clinical study
Study will include 80 diagnosed patients of Krimi
Informed written consent of Parents will be taken then divided in two groups. Case data will be recorded Randomization and allocation
Group allocation in Group A is trial Group and Group B is control group. Vidangadi Yavagu will be given to Group A and Tab Albendazole will be given to group B. Assessment of Subjective & Objective parameters
Follow up on 0th, 7th, 14th day of treatment, Observation will be noted. Data analysis will be done by using appropriate statistical test.
INCLUSION CRITERIA 1. Age group between 3 to 12 years. 2. Patients irrespective of their sex, religion & economic status. 3. Patients having 2 or more sign and symptoms of krimi viz. Udarshool, gudakandu, bhaktadwesha, jwara, chhardi. 4.Subject and parent/ legal guardian willing to provide written infomed consent/ assent and abide the trial procedures.
EXCLUSION CRITERIA 1. Patients below age 3 and above 12 year. 2. Patients with congenital abnormalities. 3. Patients with nematodes infestation with obstruction, pulmonary eosinophilia, cholecysitis, pancreatitis, malignancies, STD’s disease. 4. Any other systemic diseases which interfere with longterm treatment.
WITHDRAWAL CRITERIA 1. Children fails to report for follow up. 2. Patient willing to discontinue during trial treatment. 3. Patient not giving written consent form. |