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CTRI Number  CTRI/2025/08/093061 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trial to study the efficacy of dadimadi avaleha in aruchi (Poor appetite) in children of age group 2 to 18 years 
Scientific Title of Study   Randomized open controlled clinical study to evaluate the efficacy of dadimadi avaleha in aruchi with special reference to poor appetite in children of age group 2 tO 18 yrs . 
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 Neha Vilas Randive  
Designation  PG Scholar  
Affiliation  LRP Ayurvedic medical college and hospital ,PG Institute and Research center ,urun islampur  
Address  Pediatric department 2 nd floor LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli Sangli MAHARASHTRA 415409 India
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA
415409
India 
Phone  9168114800  
Fax    
Email  neharandive2122@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Patil 
Designation  Assistant Professor  
Affiliation  LRP Ayurvedic medical college and hospital ,PG Institute and Research center ,urun islampur  
Address  Pediatric department 2 nd floor LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli Sangli MAHARASHTRA 415409 India
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA
415409
India 
Phone  9860970379  
Fax    
Email  sandeep.patil76.sp@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neha Vilas Randive  
Designation  PG Scholar  
Affiliation  LRP Ayurvedic medical college and hospital ,PG Institute and Research center ,urun islampur  
Address  Pediatric department 2 nd floor LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli Sangli MAHARASHTRA 415409 India
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA
415409
India 
Phone  9168114800  
Fax    
Email  neharandive2122@gmail.com   
 
Source of Monetary or Material Support  
LRP Ayurvedic Medical College and hospital, PG institute and research centre,Yeun Islampur -415409 
 
Primary Sponsor  
Name  Dr Neha Vilas Randive  
Address  LRP Ayurvedic medical college and Hospital and PG institute and research centre, urun islampur 415409 
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 Neha Vilas Randive  LRP Ayurvedic medical college and hospital ,PG Institute and Research center ,urun islampur  Pediatric department 2 nd floor LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli Sangli MAHARASHTRA 415409 India Pediatric department 2 nd floor LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur Sangli Sangli MAHARASHTRA 415409 India
Sangli
MAHARASHTRA 
09168114800

neharandive2122@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-LRP Ayurvedic Medical College and hospital post graduate institute and research centre, Islampur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: ARUCIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-syp cyproheptadinecontent- cyproheptadine hydrochloride 2 mg, alcohol 5 % , sorbic acid 0.1% .
2Intervention ArmDrugClassical(1) Medicine Name: Dadimadi Avleha, Reference: Bhavprakash chikista prakaran bhag 2, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3.2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshnajal), Additional Information: contents- Dadim, Tejpata,Elaichi,Khand,Dalchini.
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1.patients having reduced food intake.
2.patient having aruchi not more than one month.
 
 
ExclusionCriteria 
Details  1.Patients known case of severe anemia, jaundice any underline infection.
2. Poor appetite more than 1 month.
3. Patients with malnutrition.
4. Patients with k/c/o genetic disease in born error of metabolism.
5. Children are below 2 years and above 18 years. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Dadimadi Avleha is significantly effective in management of Aruchi with special refrence to poor appetite in childrens of age 2 to 18 years.  30 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Dadimadi Avleha is not significantly effective in management of Aruchi with special refrence to poor appetite in childrens of age 2 to 18 years.  30 days. 
   
To study the effects of ayurvedic dadimadi avleha   30 days with follow up on 0 ,15,30 days  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/09/2025 
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  
According to ayurveda aruchi means the loss of taste in food, poor appetite is the condition manifested due to the disturbed of gastro -intestinal tract. Tongue is the main site of the manifestation of aruchi or loss of taste. In ayurvedic term condition is called as aruchi ’A’ means absence and Ruchi means taste in food.  In Charak Samhita, sutrasthana in vividhashitapitiya adhyaya stated the description of dhatu pradoshaja vikara its principle along with its managements. Dhatu pradoshaja vikara is a condition in which dhatu are in various state .If rasa dhatu is not in proper form then all remaining dhatu are also not formed in proper 
so, here aruchi is under rasa prodoshaja vikaraAccording to Acharya Sushrut the disease in which there is no ruchi in food is called Aruchi .There are sharirik and manasik two types of aruchi in sharirik -vat, pitta, kapha and sanipathaj. manasik is shok, bhay, aagntuj.Drugs of dadimadi avaleha is predominantly amla, tikta, katu Rasa, laghu, ruksha ushna in guna. Madhura in vipak and anushna sheet in virya. Due to these pharmacodynamics it has specific action on jatharagni and ultimately on abhyavaran and jaran shakti so they are good work in aruchi In pediatrics age group body needs proper nutrition for normal growth and development. In pediatrics age group due to poor appetite most of children having delayed milestone, weight loss, lack of sleep, persistent tiredness so children are not active. Now a day’s aruchi is a common problem. Due to aruchi in children 
bhaktdvesha is emerging problem. Prevalence rate is 25% to 35% .Parents are ignore their children due to hurry and worry lifestyle of them. So it is most important to study on this topic. Multiple modern preparations are available as appetizers like cyproheptadine but they have side effects. Very less ayurvedic preparation have been studied in aruchi. Many dietic regimen and simple medicine helps in maintaining the normal state of agni with minimum efforts. Till date no studies have been carried out to evaluate the effect of dadimadi avaleha in aruchi.Patient age group of 2 to 18 years will be selected irrespective of sex and socioeconomic status and religion, and effect will be assessed over the span of 30 days ,total study duration will be of 1 year. Sample size selected is 80 and study design selected is randomized control trial.
 
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