EFFICACY OF BHRINGARAJASAVA IN THE MANAGEMENT OF BALSHOSHA IN PRE SCHOOL-CHILDREN: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Weight
研究概览
简要总结
NEED OF THE STUDY
Childhood under nutrition accounts for 45% of Under 5 mortality alone and poses a key public health challenge in India. It is a major global health problem, resulting in childhood morbidity, mortality, impaired intellectual development, suboptimal adult work capacity, and increased risk of diseases in adulthood.[i] As per recent report of NFHS 5 (2020-21) the nutrition reveals that in Rajasthan 27.6% of children under the age of five are underweight, 31.8% are stunted and 16.8% are wasted.[ii]
Although India has shown remarkable progress and has a number of nutritional programs but still malnutrition is a big problem in our country. Several cultural, societal, and economic issues make it difficult to achieve the goals even with a variety of dietary programs. Considering all the variables, it is imperative that we stress the need of treating childhood malnutrition both preventatively and therapeutically.
India celebrates the first week of September as National Nutrition Week and dedicates the entire month for Nutrition related campaigns and activities. The Government of India had launched multiple schemes to address the problems of the high rate of malnutrition in India. But, still there is no satisfactory solution and management for malnutrition and it is the need of the time to look into the alternative systems for the management. Therefore with these perspectives the present trial entitled “A Clinical Study to Evaluate the Efficacy of Bhringarajasava in the Management of Balshosha in pre school Children ” has been planned from Sahasra Yogam, Aasava Prakarana, page no.250-251.
Trial Drug: Bhringarajasava (Sahastra Yog, AsavaPrakran, second edition P.N.250-251)
| S.N. |
Name of Drug
Latin Name
Family
Useful Part
|1.
Bhringaraj
Ecliptaprostrata
Asteraceae
Whole plant
12.250lts
|2.
Haritaki
Terminalia chebula
Combretaceae
Fruit
384 gms
|3.
Pippali
Piper longum
Piperaceae
Fruit
96 gm
|4.
Jatiphala
Myristica fragrans
Myristicaceae
Fruit
96 gm
|5.
Lavang
Syzygium aromaticum
Myrtaceae
Flower Bud
96 gm
|6.
Twak
Cinnamomum zeylanicum
Lauraceae
Dry Bark
96 gm
|7.
Ela
Elettaria cardamomum
Zingiberaceae
Sd.
96 gm
|8.
Patri
Cinnamomum tamala
Lauraceae
Dried Leaf
96 gm
|9.
Nagkeshar
Mesua ferrea
Calophyllaceae.
Flower[i]
96 gm
|10.
Gudd
Jaggery
9.600 kg
[i]Dravyaguna-Vijnan Vol. II by Prof. P.V. Sharma published by Chaukhambha Bharati Academy, Varanasi, India, Reprint 2009,
[i] Black R et al. Maternal and child undernutrition and overweight in low-income and middleincome countries. Lancet, 2013;382:427–51
[ii]https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://main.mohfw.gov.in/sites/default/files/NFHS-5\_Phase-II\_0.pdf&ved=2ahUKEwis0qGRy92FAxWgdPUHHXV\_BPMQFnoECDAQAQ&usg=AOvVaw1xbRlN9Fq5qBwWUSTTFg69
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.00 Year(s)(—)
- 性别
- All
入选标准
- •Weight for height Z score of minus 1SD TO less than minus3SD Children aged 3 year to 6 years of either sex with no major medical complication.
- •Mother and care taker trainable to provide home based diet.
- •Parents willing to participate in the clinical trial.
排除标准
- •children suffering from severe malnutrition who need hospitilization.
- •Weight for height Z score is greater than minus 3SD .
- •Tuberculosis, Cerebral palsy, Congenital heart diseases, Known metabolic disorders, Known mal-absorption syndromes, Chromosomal malformations, Renal or hepatic disorders.
结局指标
主要结局
Change in Weight
时间窗: every followup visit in every 14 days
次要结局
- Change in Ayurvedic symptoms of Balshosh(Change in MUAC, Skin fold thickness and BMI.)
研究者
Dr Kamalesh Fagore
National Institute of Ayurveda Jaipur
