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CTRI Number  CTRI/2018/02/011931 [Registered on: 16/02/2018] Trial Registered Prospectively
Last Modified On: 15/02/2018
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   Clinical trial with Daadimaadi churna in loss of appetite in children 
Scientific Title of Study   A randomized controlled clinical trial to evaluate the efficacy of Daadimaadi churna in loss of appetite in children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyanka Sharma 
Designation  P.G. Scholar 
Affiliation  KLEU’s Shri B.M.K. Ayurveda Mahavidyalaya and Hospital and Research Centre 
Address  Dept. of KAUMARBHRITYA, KLEU’s Shri B.M.K. Ayurveda Mahavidyalaya and Hospital and Research Centre, Shahapur, Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9148308360  
Fax    
Email  priyanka.sharma210390@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena K H 
Designation  Reader, Dept. of Kaumarbhritya 
Affiliation  KLEU’s Shri B.M.K. Ayurveda Mahavidyalaya and Hospital and Research Centre 
Address  Dept. of KAUMARBHRITYA, KLEU’s Shri B.M.K. Ayurveda Mahavidyalaya and Hospital and Research Centre, Shahapur, Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9538469641  
Fax    
Email  dr.veenatonne@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanka Sharma 
Designation  P.G. Scholar 
Affiliation  KLEU’s Shri B.M.K. Ayurveda Mahavidyalaya and Hospital and Research Centre 
Address  Dept. of KAUMARBHRITYA, KLEU’s Shri B.M.K. Ayurveda Mahavidyalaya and Hospital and Research Centre, Shahapur, Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9148308360  
Fax    
Email  priyanka.sharma210390@gmail.com  
 
Source of Monetary or Material Support  
DrPriyanka Sharma KLEUs Shri BMK Ayurveda Mahavidyalaya Shahpur Belgavi Karnataka - 590003 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Priyanka Sharma  K.L.E.U.’s Shri B.M.K. Ayurvedic Hospital & research centre  Room no. 10, Department of Kaumarbhritya
Belgaum
KARNATAKA 		 9148308360

priyanka.sharma210390@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Loss of Appetite,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Daadimaadi churna  Ingredients Botanical name Part used Ratio RASA GUNA VIRYA VIPAKA PRABHAVA Dadima Punica granatum Fruit seeds 2 part Kashay , amla Laghu , snigdha Ushna Madhur Rochan, Hridya Twaka Cinnamomnm zeylanicum Bark Katu,tikta,madhur Laghu,ruksha,tikshana Ushna Katu KaphaVata Doshahara Sukshma Ela Elettaria cardamomum Fruit Katu, madhur Laghu, ruksha Sheeta Madhur Tridoshahara Tejapatra Abies webbiana Patra Tikta , madhur Laghu , tikshana Ushna Katu VataKapha Doshahara Sharkara Saccharum officinarum Extract 3 part Madhur rasa Twak,Sukshma Ela,Tejapatra collectively 1 part DRUG DOSE: Before food (BF) TDS ×7Days Age Drug dose 3y 3gm 4y 4gm 5y 5gm 6y 6gm 7y 7gm 8y 8gm Anupana - Jala (ushna)  
Comparator Agent  Hinguvashtak churna  DRUG DOSE: Before food (BF) TDS ×7Days Age Drug dose 3y 3gm 4y 4gm 5y 5gm 6y 6gm 7y 7gm 8y 8gm Anupana - Jala (ushna) 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Children having age in between 3 to 8 years, irrespective to sex and religion.
2.Children presenting the features decreased or Loss of appetite.
 
 
ExclusionCriteria 
Details  1.Children having age less than 3 years and more than 8 years.
2.Patients suffering from any known acute or chronic illnesses that might interfere with study e.g acute infections, malignancies, thyroid problems etc.
3.Children having any associated life threatening medical or surgical disorders.
4.Children with any long term medications that may interfere with the result like for Diabetes etc will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Daadimadi churna will be more effective to increase the appetite in children.  7 Days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   19/02/2018 
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   Yet to be Published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Decreased or loss of appetite is very common symptom found in pediatric population accounting to more than 50%.In pediatric population body needs proper diet and nutrition. Poor nutrition leads to slowed growth and health problems.Some common causes for loss of appetite are picky eating, illness, stress, depression, intestinal worms, constipation, lack of physical activity etc.Decreased or Loss of appetite in children occurs because of variety of reasons either it may be physiological, psychological or diseased condition. Loss of taste / dislike for food is the main symptom in loss of appetite, it may be because most of children having nature of  picky eating. So the loss of appetite here is because of psychological feelings/dislike towards the food & daadima is considered hridya & ruchikara which may combat the psychological cause for loss of appetite. Daadimaadi churna contains daadima, tejpatra, ela, daalchini and sharkara which is palatable and effective at physiological, psychological as well as in diseased condition. Therefore there is a need to evaluate the effect of  daadimaadi churna in increasing appetite in children. 
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