| CTRI Number |
CTRI/2026/03/106040 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [other] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to assess the effectiveness of Parasiyadi Choorna in treating Pureeshaja Krimi (intestinal worms infestation) |
|
Scientific Title of Study
|
A Randomised controlled clinical study to evaluate the efficacy of Parasiyadi Choorna in the management of Pureeshaja Krimi 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 |
Dr Waghmode Pravin Maruti |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of kaumarbhrithya 3rd floor Alvas Ayurveda Medical College and Hospital, Moodubidri, Dakshin Kannada
Karnataka
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9960315558 |
| Fax |
|
| Email |
pravinwaghmode00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudha |
| Designation |
Associate Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of kaumarbhrithya 3rd floor Alvas Ayurveda Medical College and Hospital, Moodubidri, Dakshin Kannada
Karnataka
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9353771815 |
| Fax |
|
| Email |
sudharaj22311@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Waghmode Pravin Maruti |
| Designation |
PG scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of kaumarbhrithya 3rd floor Alvas Ayurveda Medical College and Hospital, Moodubidri, Dakshin Kannada
Karnataka
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9960315558 |
| Fax |
|
| Email |
pravinwaghmode00@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital, Moodubidri, Dakshin Kannada
Karnataka
574227
India |
|
|
Primary Sponsor
|
| Name |
Dr Waghmode Pravin Maruti |
| Address |
Alvas Ayurveda Medical College and Hospital, Moodubidri, Dakshin Kannada
Karnataka
574227
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 Waghmode Pravin Maruti |
Alvas Ayurveda Medical College and Hospital |
Department of kaumarbhrithya 3rd floor Alvas Ayurveda Medical College and Hospital, Moodubidri, Dakshin Kannada
Karnataka
574227
India
Dakshina Kannada
KARNATAKA |
9960315558
pravinwaghmode00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Alvas Ayurveda Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B839||Helminthiasis, unspecified. Ayurveda Condition: KRUMIH/SANJATAKRUMI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Parasiyadi choorna, Reference: Bhaishajya Ratnavali 11th chapter shloka no. 15, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidangadi choorna, Reference: Bhaishajya Ratnavali 11chapter shloka no. 17, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age group between 3 to 12 years irrespective of gender, religion and socioeconomic status.
2. Children having Udara Shoola and Gudakandu in association with one or more symptoms of Pureeshaja Krimi
3. Children diagnosed with infestation of Ascaris Lumbricoids, Entrobius vermicularis, Necator americanus, Ancylostoma duodenale (which are soil-transmitted intestinal helminths) by microscopic stool examination.
4. Children complaining worms in passing stool (Gudamukh Paryasti) along with other symptoms of Krimi |
|
| ExclusionCriteria |
| Details |
1. Ascaris infestation with complication such as intestinal obstruction, pulmonary eosinophilia.
2. Subjects who are having other systemic illness (like neurological, cardiovascular, respiratory) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| subject will be assessed to observe the improvement in guda kandu, udarshoola, Bhaktadwesha,vivarnata, |
Patient will be assessed on 0th, 8th,15th day, and followup on 29th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the repeated occurance of krimi |
Before treatment, 8th day, 15 th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2026 |
| 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 Yet Recruiting |
| 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
|
The study is randomized, controlled, comparative clinical study with the standard drug vidangadi choorna and Interventional drug Parasiyadi choorna with the dosage of 3-5yrs =2gms into divided doses, 6-9yrs =3.75gms divided doses, 10 - 12yrs = 5.5 divided doses before food. The study is conducting on subjects of Krimi belonging to age of 3 to 12 years who has given written and verbal consents by parents for undergoing clinical study. Study will be conducting in Alvas Ayurveda medical college and Hospital moodubidri. Interventional period of this study is 15 days, assessment will be done before treatment, 8th, 15th day
|