CTRI/2024/08/071931 [Registered on: 05/08/2024] Trial Registered Prospectively
Last Modified On:
05/08/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Clinical Study on Aptivate syrup in loss of appetite
Scientific Title of Study
Evaluation of efficacy and safety of Aptivate syrup in children with non-specific anorexia – An open label, randomized, comparative, multicentric, interventional, prospective clinical study
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Aptivate/Lupin/2024/1, Version 1.0, 25th June 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shishir P Pande
Designation
Assistant Professor
Affiliation
Ayurved Seva Sangh,Ayurved Mahavidyala, Ganeshwadi, Nashik
Address
Department of Rasashastra, OPD No. 9, Ground Floor, Ayurved Seva Sangh, Ayurved Mahavidyala, Ganeshwadi, Nashik, India.
Nashik MAHARASHTRA 422003 India
Phone
09420830818
Fax
Email
shishir.nsk@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. Fourth Floor,
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. Fourth Floor,
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
3rd Floor, Kalpataru Inspire Bldg., Opp Hotel Grand Hyatt, Santacruz-East. Mumbai, Pin- 400051, Maharashtra, India
Primary Sponsor
Name
Lupin Limited
Address
3rd Floor, Kalpataru Inspire Bldg., Opp Hotel Grand Hyatt, Santacruz-East. Mumbai, Pin- 400051, Maharashtra, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 2
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Shishir P Pande
Ayurved Seva Sangh’s, Ayurved Mahavidyalaya & Rugnalaya
Department of Rasashastra,
OPD No. 9, Ground Floor, Ganeshwadi,
Nashik-422003, India. Nashik MAHARASHTRA
09420830818
shishir.nsk@gmail.com
Dr Vaishali Deshpande
Khemdas Ayurveda Hospital, Parul Institute of Ayurved and Research
Department of Kayachikitsa, Ground Floor, OPD No. 8, P.O. Ishwarpura, Tal-Waghodia, Dist.-Vadodara Vadodara GUJARAT
9096082950
dr.vaishalid@gmail.com
Details of Ethics Committee
No of Ethics Committees= 2
Name of Committee
Approval Status
Institutional Ethics Committe, PIAR IECHR
Submittted/Under Review
Institutional Ethics Committee, Ayurved seva Sangh’s Ayurved Mahavidyalaya, Nashik
No intervention. Follow up for a period of 6 months
Inclusion Criteria
Age From
2.00 Year(s)
Age To
12.00 Year(s)
Gender
Both
Details
1. Children diagnosed with Poor Appetite and Digestion without any underlying pathological condition without any significant weight loss over the last 3 months
2. Children having Eating Disorders falling in the criteria of - Unspecified Feeding or Eating Disorders as per DSM 5 TR criteria: (This category applies to presentations in which symptoms characteristic of a feeding and eating disorder that cause clinically significant distress or impairment in social, occupational, or other important areas of functioning predominate but do not meet the full criteria for any of the disorders in the feeding and eating disorders diagnostic class. The unspecified feeding or eating disorder category is used in situations in which the clinician chooses not to specify the reason that the criteria are not met for a specific feeding and eating disorder and includes presentations in which there is insufficient information to make a more specific diagnosis
ExclusionCriteria
Details
1. Children with chronic illnesses and taking medications for the same or congenital abnormalities
2. Children who are currently taking any medications for appetite stimulation or digestive disorders
3. Children who have used any investigational product 1 month prior to screening in the present study
4. Children taking systemic antibiotics for any infection
5. Children with known metabolic and/or endocrine disorder/s
6. Children with any type of known GI tract disorder (including mal-absorption syndrome, etc.)
7. Children with known Liver and Renal disorders
8. Children with known immunological, hematologic disorders, neurological or
psychiatric pathologies
9. Children with known hypersensitivity to herbal ingredients used in the study product or in general to any herbal product
10. 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
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1. Change in the clinical symptoms of anorexia measured using the total effective rate (TER).
2. Change in eating behavior using Child Eating Behavior Questionnaire (CEBQ)
Screening Visit (Up to 5 days), Randomization Visit (Day 0), Visit I (Day 30), Visit II (Day 60), Visit III (Day 90), Visit IV (Day 120), Visit V (Day 150), Visit VI (Day 180)
Secondary Outcome
Outcome
TimePoints
1. Change in appetite assessed using VAS
2. Change in appetite assessed using picture based appetite assessment tool
3. Change in desire to eat, quantity of food intake, left over in the plate, number of meals taken per day and range of food taken on VAS
4. Change in anthropometric measurements
5. Change in abdominal pain, bowel habits, abdominal fullness, flatulence, over all digestion, Sleep, satiety, fatigue, general energy levels and physical activity using VAS.
6. Assessment of overall sensorial feeling
7. Assessment of drowsiness or sedation
8. Change in memory on Children Memory Questionnaire
9. Change in incidence of infections, and allergy related disorders
10. Change in onset of action and duration of action of drugs with respect to its appetite stimulating activity.
11. Global assessment of overall change to be assessed by Physician and Subject 12. Assessment of adverse events
Screening Visit (Up to 5 days), Randomization Visit (Day 0), Visit I (Day 30), Visit II (Day 60), Visit III (Day 90), Visit IV (Day 120), Visit V (Day 150), Visit VI (Day 180)
Target Sample Size
Total Sample Size="200" Sample Size from India="200" 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 3
Date of First Enrollment (India)
14/08/2024
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="0" Months="10" 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 open label, randomized, comparative, multicentric,
interventional, prospective clinical study to evaluate efficacy and safety of
Aptivate syrup in children with non-specific anorexia. The study will be
carried out in 3 to 4 centres in India. As per computer generated list,
Subjects will be randomized either to Aptivate Syrup Group or non-user group in 1:1
ratio. Participants in Aptivate syrup group will be asked to take Aptivate
syrup in a dose of 5 ml twice daily before food for a period of 6 months. Participants
in this group will not be given any intervention but will be followed up for a
period of 6 months. Primary objectives of the study will be to assess change in
the clinical symptoms of anorexia measured using the total effective rate (TER) and
change in eating behaviour using Child Eating Behaviour Questionnaire (CEBQ).
The secondary objectives of the study will be to assess change in appetite
assessed using VAS, change in appetite assessed using picture-based appetite
assessment (PBAA) tool, change in desire to eat, quantity of food intake, left
over in the plate, number of meals taken per day and range of food taken on VAS
(based on subject diary), change in anthropometric measurements i.e. height,
weight, head circumference, mid arm circumference, body mass index (BMI), Waist
circumference, Hip Circumference, Waist: HIP ratio, and skinfold thickness,
change in abdominal pain (VAS), bowel habits, abdominal fullness, flatulence,
over all digestion (VAS), Sleep, satiety, fatigue, general energy levels and
physical activity using VAS, overall sensorial feeling on consumption of study
drugs, drowsiness or sedation due to study drugs, Change in memory on Children
Memory Questionnaire (CMQ), change in incidence of infections, and allergy
related disorders (No of episodes, duration of episodes, no of subjects),
change in onset of action and duration of action of drugs with respect to its
appetite stimulating activity, global assessment of overall change to be
assessed by Physician and Subject and adverse events randomization visit (Day
0), visit I (Day 30), visit II (Day 60), visit III (Day 90), visit IV (Day
120), visit V (Day 150), visit VI (Day 180)