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CTRI Number  CTRI/2024/07/070731 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Mahapaishachika Ghrita along with Diet counselling in Karshya with special reference to Undernutrition in Preschool children 
Scientific Title of Study   Randomized controlled clinical trial to study the add on effect of Mahapaishachika Ghrita along with Diet counselling in Karshya with special reference to Undernutrition in Preschool children 
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 Akash Mohanrao Deshmukh 
Designation  MD Scholar Kaumarbhritya (Ayurveda) 
Affiliation  L.R.P. AYURVEDIC HOSPITAL AND REASEARCH CENTER URUN ISLAMPUR 
Address  OPD NO. 02 Department of Kaumarbhritya L.R.P. AYURVEDIC HOSPITAL AND REASEARCH CENTER URUN ISLAMPUR

Sangli
MAHARASHTRA
415409
India 
Phone  9420762484  
Fax    
Email  adeshmukh4545@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Jyotsna Ahir 
Designation  Asso. Professor Kaumarbhritya 
Affiliation  L.R.P. Ayurvedic Medical college urun Islampur 
Address  OPD no. 02 Department of Kaumarbhritya- Balrog L.R.P. AYURVEDIC HOSPITAL AND REASEARCH CENTER URUN ISLAMPUR

Sangli
MAHARASHTRA
415409
India 
Phone  7276538181  
Fax    
Email  drjyotsnaahir@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Jyotsna Ahir 
Designation  Associate Professor Kaumarbhritya 
Affiliation  L.R.P. Ayurvedic Medical college urun Islampur 
Address  OPD NO. 02 Department of Kaumarbhritya L.R.P. AYURVEDIC HOSPITAL AND REASEARCH CENTER URUN ISLAMPUR

Sangli
MAHARASHTRA
415409
India 
Phone  7276538181  
Fax    
Email  drjyotsnaahir@gmail.com  
 
Source of Monetary or Material Support  
LRP Ayurvedic Medical College Hospital and research center Urun Islampur Sangli Maharashtra India pin code-415409 
 
Primary Sponsor  
Name  LRP Ayurvedic Hospital And Research Center 
Address  L.R.P. Ayurvedic Hospital And Reasearch Center Prakashnagar, urun Islampur 
Type of Sponsor  Research institution and hospital 
 
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 Akash Mohanrao Deshmukh  L.R.P. Ayurvedic Hospital And Reasearch Center urun Islampur  OPD NO. 02 Department of Kaumarbhritya L.R.P. Ayurvedic Hospital And Reaseach Center urun Islampur
Sangli
MAHARASHTRA 		 9420762484

adeshmukh4545@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Loknete Rajarambapu Patil Ayurved Mahavidyalay Sangli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Having signs and symptoms Karshya 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Mahapaishachika Ghrita, Reference: Ashtang Sangrah Uttarsthan, Route: Oral, Dosage Form: Ghrita, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -according to weight ghrita doses are calulated
2Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Diet and Counselling for every follow up till 90 days, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1.Children between the ages of 3 to 6 years (preschool children) of either sex having signs and symptoms of Karshya.
2. Parents/ legal guardians willing to give written informed consent. 
 
ExclusionCriteria 
Details  1. Children with known case of systemic disorder.
2. Children with known case of any endocranial disorder, genetic anomalies.
3. Children with known case of immunosuppressive disorder. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Mahapaishachika Ghrita in Karshya  3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
1.To reduce the undernutrition in 3 months.
2.To study the literature related to concept of “Undernutrition”.
3.To study the concept of ‘Mahapaishachika Ghrita’.
4.To study the concept of Lehan.
5.To study the concept of Diet Counselling.
 		 12 Months 
 
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 
Date of First Enrollment (India)   25/07/2024 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This is randomised controlled clinical trail to study in which ayurvedic formulation will be provided to 80 patients showing signs and symptoms of Karshya and out of this 80 patients,  40 patients will be given  diet and counselling . The age group taken for study trial will be between 3 Years to 6 Years and the total duration of study will be 10 months . Final conclusion will be drawn on the basis of statistical method. 
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