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CTRI Number  CTRI/2024/03/063629 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Preenana Modaka (calumpong nut sweet balls), an Ayurvedic preparation on nutritional status of underweight children below five year age group. 
Scientific Title of Study   Effect of Preenana modaka, an Ayurvedic nutraceutical preparation and Hyderabad Mix (supplementary food for malnutrition) on growth parameters in underweight children of under-five age group: A double blind, randomized controlled, pilot study.  
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 Champa Pant 
Designation  Professor  
Affiliation  Sushrutha Ayurvedic Medical College and Hospital 
Address  OPD No 3, Department of Kaumarabhritya, Ground Floor, Sushrutha Ayurvedic Medical College and Hospital, Bengaluru Prashanthi Kuteera Jodi Bingipura, Jigni Hobli, Anekal Taluka, Bangalore 560105

Bangalore
KARNATAKA
560076
India 
Phone  09986189230  
Fax    
Email  champapantdr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Champa Pant 
Designation  Professor  
Affiliation  Sushrutha Ayurvedic Medical College and Hospital 
Address  OPD No 3, Department of Kaumarabhritya, Ground Floor, Sushrutha Ayurvedic Medical College and Hospital, Bengaluru Prashanthi Kuteera Jodi Bingipura, Jigni Hobli, Anekal Taluka, Bangalore 560105

Bangalore
KARNATAKA
560076
India 
Phone  09986189230  
Fax    
Email  champapantdr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Champa Pant 
Designation  Professor  
Affiliation  Sushrutha Ayurvedic Medical College and Hospital 
Address  OPD No 3, Department of Kaumarabhritya, Ground Floor, Sushrutha Ayurvedic Medical College and Hospital, Bengaluru Prashanthi Kuteera Jodi Bingipura, Jigni Hobli, Anekal Taluka, Bangalore 560105

Bangalore
KARNATAKA
560076
India 
Phone  09986189230  
Fax    
Email  champapantdr@gmail.com  
 
Source of Monetary or Material Support  
Sushrutha ayurvedic medical college and hospital Pharmacy, Bengalore 
 
Primary Sponsor  
Name  Sushrutha Ayurvedic Medical College and Hospital Bengalore 
Address  Prashanti Kuteera, Jodi Bingipura, Anekal Taluka, Bangaloreb560105 
Type of Sponsor  Private medical college 
 
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 Champa Pant  Sushrutha Ayurvedic Medical College and Hospital  OPD no 3, Department of Kaumarabhritya, ground Floor, Sushrutha Ayurvedic Medical College and Hospital, Bengaluru Prashanthi Kuteera Jodi Bingipura, Jigni Hobli, Anekal Taluka, Bangalore 560105
Bangalore
KARNATAKA 
09986189230

champapantdr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) SAMC & H  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: BALAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Preenana Modaka, Reference: Ashtanga Hridaya, Uttara Sthana, chapter1,verse 39,40, Route: Oral, Dosage Form: Modaka , Dose: 86(g), Frequency: od, Bhaishajya Kal: Madhyabhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: water), Additional Information: -
2Comparator Arm (Non Ayurveda)-Hyderabad Mix Whole wheat–40gm, Bengal gram–16gm, Ground nut–10gm, will be dry-roasted and powdered. Twenty grams of jaggery will be heated to make a syrup and mixed with powdered ingredients and will be converted into sweet balls. A total 86 gm will be given every day to the children in control group.
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Children between 2-5 years of age with low weight for age (with a Z score of less than -2 SD from the median of the WHO child growth standards. 
 
ExclusionCriteria 
Details  Children with any concurrent systemic illness will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Weight  One month and at follow up (2 month) 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Height, BMI, Abdominal circumference, Mid upper arm circumference and skin fold thickness  One month and at follow up (2 month) 
 
Target Sample Size
Modification(s)  
Total Sample Size="24"
Sample Size from India="24" 
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)   01/12/2024 
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="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  

Prevalence of under-weight children in India is among the highest in the world.[i] National Family Health Survey (NFHS)-5 (2019-21) indicates that in India, 32.1% children below five years are underweight, 35.5 % are stunted and 19.3 % are wasted. Although, various nutrition programmes evolving Government, Non-government organizations are being implemented to tackle the situation the success seems far. In such situation, food supplements described in Ayurveda needs to be scientifically studied so that ancient wisdom of Ayurveda can be used to improve the nutritional status of malnourished children in the country.

Preenana Modaka is an Ayurvedic nutraceutical prepared with powders of Priyala Majja  (Buchanania  lanzan) known as Cuddapah almond/nut and commonly used in several Indian dishes,  Yasthimadhu (Glycyrrhiza  glabra ),Laja( Puffed rice ), Sitopala (sugar candy) and Madhu (honey).[ii] It is an energy dense sweet preparation which is prescribed as a nutritive weaning food. It is easily palatable, tasty and is rich in nutrients.

Both Priyala and Yashthi are Madhura (sweet) and Rasayana (rejuvinators). By virtue of its Snigdha (unctuous), Madhura (sweet), Vrimhana (nourishing), Balya (strengthening)  properties, Priyala nourishes all the tissues. Preenana Modaka can be a used as a tasty and satiating complementary food in malnourished children under 5 years of age. Children with borderline malnutrition or children who are failing to thrive can benefit from small energy dense feeds at frequent intervals. Nutritional supplements in the form of Modaka (sweet balls) are ideal for this purpose. However, there is a need to assess the efficacy of Preenana Modaka in comparison to some established nutritional supplement. Hyderabad mix is a homemade supplementary food developed by National Institute of Hyderabad which is used as a nutritional supplement for underweight children in a dose of 86 grams per day. [iii] 

 

This study is designed as a double-blinded, randomized, controlled, where Preenana Modaka will be studied in comparison to control Hyderabad mix in the enrolled underweight children to see its effect on the anthropometric parameters (weight, Height, BMI, Abdominal circumference, Mid upper arm circumference and skin fold thickness) of underweight children between the age of 2-5 years.



[i]  World Bank. India, Undernourished children: A call for reform and action. Available from: http://web.worldbank.org/WBSITE/EXTERNAL/COUNTRIES/SOUTHASIAEXT/0,contentMDK:20916955~pagePK:146736~piPK:146830~theSitePK:223547,00.html .

 

[ii] Vagbhata,  Ashtanga  Hridaya,  Kaviraja  Atridev  Gupta(Commentator),Vaidya  Yadunandan Upadhyaya(Ed.),  Chaukhambha  Sanskrit  Sansthan,  Varanasi,Fourteenth  Edition,  2003,  Uttara Sthana, chapter1,verse 39,40

 

[iii] Utalbasha N. Dhandargi and Padmaja A. 2018. Comparing the Effectiveness of Glycine Max Fortified Mixture (GMFM) and Hyderabad Mixture (HM) on Nutritional Status of Malnourished Children in Rural Area.Int.J.Curr.Res.Aca.Rev. 6(1): 30-34

 

 
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