| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: BALAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator 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. |
|
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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. |
|
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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.
[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 |