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CTRI Number  CTRI/2024/09/074018 [Registered on: 18/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Ayurveda formulation in school going children with loss of appetite  
Scientific Title of Study   Effect of Amalakyadi churna in school going children with loss of appetite – A double blind randomized controlled clinical trial 
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 Agrawal Prajwal Ravindra 
Designation  PG Scholar 
Affiliation  KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka 
Address  Department of Kaumarabhritya KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  8806508122  
Fax    
Email  sunnyravindra98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena Tonne 
Designation  Associate Professor 
Affiliation  KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka 
Address  Department of Kaumarabhritya KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  09538469641  
Fax    
Email  dr.veenatonne@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Veena Tonne 
Designation  Associate Professor 
Affiliation  KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka 
Address  Department of Kaumarabhritya KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka

Belgaum
KARNATAKA
590003
India 
Phone  09538469641  
Fax    
Email  dr.veenatonne@gmail.com  
 
Source of Monetary or Material Support  
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi Karnataka India 590003  
 
Primary Sponsor  
Name  Dr Agrawal Prajwal Ravindra 
Address  KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi Karnataka India 590003 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Agrawal Prajwal Ravindra  KAHER Shri B M Kananwadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Belagavi Karnataka  OPD number 10 Department of Kaumarabhritya
Belgaum
KARNATAKA 		 8806508122

sunnyravindra98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research On Human Subjects KAHER Shri B M Kananwadi Ayurveda Mahavidyalaya Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: MANDAGNIH/ AGNISADA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: AMALAKYADI CHURNA, Reference: SARANGADHARASAMHITA MADHYAMAKHANDA CHAPTER NO.06 SHLOKA NO.7, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3.5(g), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -LUKE WARM WATER), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: SHATAPUSHPADYA CHURNA, Reference: GADANIGHARA OF SHODHALA CHAPTER NO.22 AAMVATADHIKARA ADHYAYA SHLOKA NO.34, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3.5(g), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -LUKE WARM WATER), Additional Information: -
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1) Patients of either sex between age group 10-16 years
2) Patients fulfilling the diagnostic criteria 
 
ExclusionCriteria 
Details  1) Children having any other known underlying chronic health conditions like
CKD CLD and other systemic illnesses like Typhoid Gastroenteritis and Hepatitis
2) Children with any medications that may interfere with study outcomes like Antibiotics Steroids and Appetizers
3) Children with any known Psychological disorders like ADHD Autism
4) Diseases that require salt restriction like nephrotic syndrome hypertension
5) Children with Postinfection phases like viral fever fever of bacterial origin of less than 15 days 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Children Eating Behaviour Questionnaire scale
2) Measuring Hunger scale
scale 		 Baseline and 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
1) Measured by changes in weight
2) Indigestion
3) Abdominal heaviness
4) Hypersalivation
5) Dislike of food
6) Vomiting
7) Quantity of food
8) Frequency of food
9) Intensity of hunger
10) Feeling of lightness after meal
11) Activeness after meal
12) Pure belching
13) Feeling of hunger
14) Dissappearance of exhaustion these symptoms are assess by grading or scoring
15) Daily calorie intake  		 Baseline and 7th day 
 
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)   01/01/2025 
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  
         In the pediatric age group Nutrition is important for their Physical growth and Brain development Parent’s feeding habits impact their childrens eating behaviors Employed parents may struggle to prioritize their childrens dietary needs potentially resulting in issues such as decreased appetite cognitive impairment and impaired growth Appetite is conscious desire to eat that is felt as hunger and it regulates energy intake necessary for the supply of metabolic requirements

         Loss of appetite dyspepsia is the leading cause of impaired nutrition High prevalence of eating and feeding disturbances affecting about 19.8% of youth ages 11–17 years Loss of Appetite leading to Poor diets in childhood can lead to deficiencies in essential vitamins and nutrients so early assessment & intervention of loss of appetite can improve the nutritional status of the child Certainly appetite stimulants can be an effective way to boost a childs desire to eat and stimulate hunger Options include medications and lifestyle changes An appetite stimulant is also known as orexigenic

        Very few orexigenic drugs are available in modern science which is very specific as appetizers like Cyproheptadine Megestrol which have adverse effects like sedation confusion hallucinations hypotension  palpitations weight gain and
tachycardia Therefore there is a need to find an effective drug as an appetite stimulant in children suffering with loss of appetite.Amalakyadi churna is a herbal formulation specifically designed to strengthen Agni and improve digestion by its 
dipana pachana kapha shamak properties also it will increase desire to eat by its ruchikara properties Hence present study is planned to evaluate the effect of Amalakyadi churna as an appetite stimulant in school-going children
 
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