跳至主要内容
临床试验/CTRI/2025/01/078945
CTRI/2025/01/078945尚未招募2/3 期

A Comparative study on effcicacy of Suvarnaprash versus Nutrileha in the management of Karshya (SAM) in 13-24 months children : A RCT

Dr Renu B Rathi and DMIHER Wardha1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月28日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Effect of Nutri leha & Suvarnaprashan relief of the symptoms of Karshya(Severe Acute Malnutrition), on subjective and objective parameters and shifting of grades from SAM to MAM

研究概览

简要总结

ØIn Ayurveda, PEM (protein energy malnutrition) mentioned as Karshya,sukhandi, bal-shosh, kshaya etc. (malnutrition) is a disease in which to jatharagnimandya leading to dhatwagnimandya ultimately causing rasadidhatukshaya, the child becomes emaciated.Alpa bhojana (inadequate food intake), atirukshaannapana, parental negligence are the main causes of karshyaSuvarnaprash improves Intelligence, Digestive fire, physical power, rejuvenation, positivity and long life,Second trial drug Nutri Leha which contains Ashwagandha, Trikatu, ghrita, tilataila, madhu having qualities like rasayana, deepana, pachana, brumhana which can be beneficial in improving the condition of children suffering from Karshya. In developing countries like India , malnutrition in children is a challenging and significant public health problem in spite of implementing many nutritional policies to overcome it.Globally, 161 million children under five year age are suffering from malnutrition this condition is worse in developing countries like India with a prevalence rate of 48 %. Population- Toddlers from 13-24 months of age suffering from Karshya irrespective of religion, race, gender and socioeconomic condition. Intervention-Nutri Leha in a semisolid form – a leha preparation.Comparison-Swarnaprash, Outcome-Effect of Nutri leha &  Suvarnaprashan relief of the symptoms of Karshya(Severe Acute Malnutrition), on subjective and objective parameters and shifting of grades from SAM to MAM. Time-90 days

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
13.00 Month(s) 至 24.00 Month(s)(—)
性别
All

入选标准

  • Toddlers from 13-24 months of age Suffering from karshya Toddlers having low weight for height, BMI for age and children falling in grade 3 and 4 classification of PEM according to IAP.

排除标准

  • Infants below 12 months and toddlers above 2 yrs of age.
  • Toddlers suffering from infectious diseases like tuberculosis, HIV, etc Diagnosed cases of Hyperthyroidism, malabsorption syndrome, congenital anomalies Parents/ guardian who are not ready to give informed/ written consent for the study.
  • Toddlers suffering from complicated SAM.

结局指标

主要结局

Effect of Nutri leha & Suvarnaprashan relief of the symptoms of Karshya(Severe Acute Malnutrition), on subjective and objective parameters and shifting of grades from SAM to MAM

时间窗: 12 Weeks

次要结局

  • Immunomodulation(90 Days)

研究者

发起方
Dr Renu B Rathi and DMIHER Wardha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Renu Bharat Rathi

MGACH RC DMIHER Wardha

研究点 (1)

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