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临床试验/CTRI/2024/03/063629
CTRI/2024/03/063629尚未招募2 期

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.

Sushrutha Ayurvedic Medical College and Hospital Bengalore1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
Change in Weight

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
2.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Children with any concurrent systemic illness will be excluded.

结局指标

主要结局

Change in Weight

时间窗: One month and at follow up (2 month)

次要结局

  • Change in Height, BMI, Abdominal circumference, Mid upper arm circumference and skin fold thickness(One month and at follow up (2 month))

研究者

发起方
Sushrutha Ayurvedic Medical College and Hospital Bengalore
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Champa Pant

Sushrutha Ayurvedic Medical College and Hospital

研究点 (1)

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