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临床试验/CTRI/2025/07/091551
CTRI/2025/07/091551尚未招募2 期

EFFICACY OF BHRINGARAJASAVA IN THE MANAGEMENT OF BALSHOSHA IN PRE SCHOOL-CHILDREN: A RANDOMIZED CONTROLLED TRIAL

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月25日最近更新:

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

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Kamalesh Fagore

National Institute of Ayurveda Jaipur

研究点 (1)

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