| CTRI Number |
CTRI/2014/07/004756 [Registered on: 24/07/2014] Trial Registered Prospectively |
| Last Modified On: |
12/08/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical of Appetol syrup in children suffering from non-specific anorexia (loss of appetite) |
|
Scientific Title of Study
|
A clinical study to evaluate efficacy and safety of Appetol syrup in children suffering from non-specific anorexia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AH/APPE/01/2014, Version 0, 24th March 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T Y Swami |
| Designation |
Associate Professor Department of Balrog |
| Affiliation |
Govt. Ayurvedic College and Hospital Tuijapur Road Osmanabad |
| Address |
1st Floor Room No 35 Govt Ayurvedic College and Hospital Tuijapur Road Osmanabad
Osmanabad
MAHARASHTRA
413501
India |
| Phone |
9422655962 |
| Fax |
|
| Email |
swamity@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arjun Kohli |
| Designation |
Director |
| Affiliation |
ARJUN HEALTHCARE |
| Address |
ARJUN HEALTHCARE
11 Krypton towers
New Prabhadevi Road
Prabhadevi Mumbai
Mumbai
MAHARASHTRA
400025
India |
| Phone |
8108829777 |
| Fax |
|
| Email |
arjunhealthcare2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun Kohli |
| Designation |
Director |
| Affiliation |
ARJUN HEALTHCARE |
| Address |
ARJUN HEALTHCARE
11 Krypton towers
New Prabhadevi Road
Prabhadevi Mumbai
Mumbai
MAHARASHTRA
400025
India |
| Phone |
8108829777 |
| Fax |
|
| Email |
arjunhealthcare2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| ARJUN HEALTHCARE
11 Krypton towers
New Prabhadevi Road
Prabhadevi Mumbai
|
|
|
Primary Sponsor
|
| Name |
ARJUN HEALTHCARE |
| Address |
11 Krypton towers New Prabhadevi Road Prabhadevi Mumbai |
| 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 T Y Swami |
Department of Balrog |
Govt Ayurvedic College and Hospital Tuijapur Road Osmanabad
Osmanabad
MAHARASHTRA |
9422655962
swamity@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt Ayurvedic College and Hospital Tuijapur Road Osmanabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
non-specific anorexia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
APPETOL SYRUP |
Each 100 ml syrup contains water extracts derived from Draksha (Vitis vinifera)
Trikatu (Zingiber officinale,
Piper longum (Piper nigrum)
Papaya satva (Carica papaya) Vidang (Embelia ribes) Dadim beej (Punica granatum) Ajwain (Carum copticum)Jeera (Cuminum cyminum)Saunf (Foeniculum vulgare)Syrup (Sugar base) and Flavor, DOSE:10 ml twice daily before meals for 45 days
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1 The informed consent document must be read signed and dated by subjects legally authorized representative before conducting any study procedures or examination
2 Males and females between 5 to 9 years of age
3.Subjects suffering from non specific anorexia
4.Subjects having normal vital parameters
|
|
| ExclusionCriteria |
| Details |
1 Children with SNAQ score less than or equal to 14
2 Children with chronic illnesses congenital abnormalities
3 Subject who is on other appetite stimulants sedatives narcotics and steroidal drugs
4 Subjects who have received treatment another investigational agent within last thirty days from Screening Visit
5 Subjects who have received chemotherapy or radiation therapy within the past 5 years
6 Subjects on systemic antibiotics or systemic therapy with cytotoxic drugs
7 Subjects having metabolic and or endocrine disorders
8 Subjects with any type of GI tract disorder including malabsorption syndrome etc
9 Subjects with liver and renal disorders
10 Subjects with known immunological, hematologic disorders or malignancy
11 Subjects having known neurological or psychiatric pathologies
12 Subjects with history of raised levels of cortisol abnormalities of thyroid hormone growth hormone and insulin secretion
13 Subject or LAR refuse to sign informed consent form
14 Subjects having a known hypersensitivity to Appetol Syrup and any of the ingredients of Appetol Syrup
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Appetol syrup in children suffering from non-specific anorexia by assessing SNAQ Scale |
0 day 15 day 30 day 45 day and 60 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Weight and BMI
2 Activity level on PAQ-C Scale
3 Abdominal pain abdominal distension, flatulence, constipation, nausea, vomiting
4 Overall improvement by Physician and Patient’s LAR at the end of the study.
5 Acceptability of drug
6 Drowsiness or sedation
7 Adverse events
8 Drug tolerability by patients LAR and physician at the end of the study
|
0 day 15 day 30 day 45 day and 60 day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/08/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an Open Labeled, Non-comparative,
Prospective, Single Center Clinical Study to evaluate efficacy and safety of
Appetol syrup in children suffering from non-specific anorexia. The study will
be done in 50 completed patients. Appetol Syrup will be given in a dose of 10
ml twice daily after meals for 45 days. After 45 days all the patients will be advised
to stop taking medicine and will be monitored for next 15 days to observe
recurrence of symptoms. The trial will be conducted at Department of Balrog, Govt.
Ayurvedic College, Tuljapur Road, Osmanabad. Primary outcome will be to
evaluate efficacy of Appetol syrup in children suffering from non-specific
anorexia by assessing SNAQ Scale. Secondary outcomes will be to evaluate
efficacy of Appetol syrup in children suffering from non-specific anorexia by
assessing Weight and BMI, Activity level on PAQ-C Scale, Abdominal pain/cramps,
abdominal distension, flatulence, constipation, nausea, vomiting, Overall
improvement by Physician and Patient’s LAR at the end of the study, acceptability
of drug, Drowsiness or sedation, Adverse events and drug tolerability by
patient’s LAR and physician at the end of the study
|