| CTRI Number |
CTRI/2025/11/097527 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on Aptivate Syrup in children with worm infection |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of deworming property of Aptivate Syrup in children suffering from Helminth Infections /helminthiasis- An open label, non-comparative, prospective, clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Aptivate/Lupin/HI/2025/1, Version 1.0, 24th Sept 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendra Mundhe |
| Designation |
Associate Professor |
| Affiliation |
KVTR Ayurvedic College and Hospital, Boradi |
| Address |
Department of Kayachikitsa, OPD No 5, Ground Floor, KVTR
Ayurvedic College and Hospital, Boradi, Tal. Shirpur, Dist. Dhule
Dhule
MAHARASHTRA
425428
India |
| Phone |
9850378206 |
| Fax |
|
| Email |
drnbmundhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Lupin Limited
11th Floor, Empire Tower, Cloud City Campus
Thane Belapur Road, Airoli East
Navi Mumbai 400708
|
|
|
Primary Sponsor
|
| Name |
Lupin Limited |
| Address |
11th Floor, Empire Tower, Cloud City Campus
Thane Belapur Road, Airoli East
Navi Mumbai 400708
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Narendra Mundhe |
KVTR Ayurvedic College and Hospital, Boradi |
Department of Kayachikitsa, OPD No 5, Ground Floor, KVTR
Ayurvedic College and Hospital, Boradi, Tal. Shirpur, Dist. Dhule, MH-
425428
Dhule
MAHARASHTRA |
9850378206
drnbmundhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KVTR Ayurved College and Hospital, Boradi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B820||Intestinal helminthiasis, unspecified. Ayurveda Condition: KRUMIH/SANJATAKRUMI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Aptivate syrup , Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 2.5(ml), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Age 3–6 years: 2.5 mL twice daily for 30 days.
Age 7–14 years: 5 mL twice daily for 30 days
| | 2 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants must be an otherwise healthy child, based on medical history, physical examination, vital signs and concomitant medications
2. Participants with presence of intestinal helminths eggs in the stool
3. Participant must be available to return to the study site for all visits, including the follow-up visit
4. Parent(s) or guardians of participants (or their legally-accepted representatives) must be willing to sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study
5. Children 6 years of age and older will be asked to assent (agree) to their participation using appropriate language to their level of understanding; assent will be documented
|
|
| ExclusionCriteria |
| Details |
1. Participant has active diarrhea (defined as the passage of 3 or more loose or liquid stools per day) at screening or at the time of randomization
2. Participant has a significant medical disorder, participant has difficulty in chewing or swallowing
3. Participant has clinically significant signs and symptoms of anaemia
4. Participant has significant wasting (greater than 2 standard deviations below the mean World Health Organization Child Growth Standards for weight-for-height or body mass index)
5. Participant has a known hypersensitivity to any ingredients of investigational product
6. Participant has preplanned surgery or procedures that would interfere with the conduct of the study during the course of study
7. Participant has taken any form of deworming medication within 30 days of entry into the study.
8. Any other condition due to which children are deemed to be unsuitable by investigator for reason(s) not specifically stated in the exclusion criteria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent reduction in fecal egg count (ova and cyst counts of various helminths) |
Screening (Days up to 5), Baseline visit (Day 0), Follow up visit 1 (Day 15) and End of study visit (Day 30) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Parasitological cure rate
2. Change in clinical symptoms i.e. abdominal pain, diarrhea, abdominal fullness, flatulence, over all digestion, Sleep, satiety, fatigue, general energy levels and physical activity
3. Change in weight
4. Safety and tolerability through adverse event (AE) reporting, vital and clinical signs and symptoms
|
Screening (Days up to 5), Baseline visit (Day 0), Follow up visit 1 (Day 15) and End of study visit (Day 30) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/11/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is an evaluation of efficacy and safety of deworming property of
Aptivate Syrup in children suffering from Helminth Infections helminthiasis- An
open label, non-comparative, prospective, clinical study. The study will be
carried out at 1 to 2 centres in India. Subjects of age group 3 to 6 years will be instructed
to take Aptivate syrup in a dose of 2.5 mL twice daily for 30 days and subjects
of age 7 to14 years will be instructed to take Aptivate syrup in a dose of 5 mL
twice daily for 30 days. Primary
objective of the study will be to assess percent reduction in fecal egg count
(ova and cyst counts of various helminths). The secondary objectives of the
study will be to assess parasitological cure rate, change
in clinical symptoms i.e. abdominal pain, diarrhea, abdominal fullness,
flatulence, over all digestion, Sleep, satiety, fatigue, general energy levels
and physical activity, change in weight, safety and tolerability through
adverse event (AE) reporting, vital and clinical signs and symptoms on screening (Days up to 5),
Baseline visit (Day 0), Follow up visit 1 (Day 15) and End of study visit (Day
30) |