| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | syp cyproheptadine | content-
cyproheptadine hydrochloride 2 mg, alcohol 5 % , sorbic acid 0.1% . | | 2 | Intervention Arm | Drug | Classical | | (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. |