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临床试验/CTRI/2025/08/092233
CTRI/2025/08/092233尚未招募2/3 期

EVALUATION OF CHATURBEEJA ARKA IN MANAGEMENT OF UDARSHOOL WITH SPECIAL REFERENCE TO INFANTILE COLIC-A RANDOMIZED CONTROLLED CLINICAL TRIAL

KLE Shri B M Kankanawadi Ayurveda Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年1月1日最近更新:
适应症
相关药物

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
There might be significant effect of Chaturbeeja arka orally in the management of Udarshoola (Infantile colic) Measured by changes in FLACC Scale and VAS Scale

研究概览

简要总结

Infantile colic characterizes by persistent and inconsolable crying in infants more in the evening than at other times of the day .

Infantile colic is a common condition causing abdominal discomfort in newborns during the first few weeks after birth. The etiology of colic is still unknown, as the studies conducted so far have been restricted due to inadequate blinding and conflicting or inconsistent results. Many proposed contributing factors, such as biological, gastrointestinal, and psychosocial elements, define colic causes.

Infant crying follows a developmental pattern, starting to increase around 2 weeks of age (corrected for gestational age at birth), peaking at 5 to 6 weeks, and declining by about 12 weeks.

The prevalence of infantile colic between the age 0 to 6 months, ranges between 10 to 15 percentage.

The most common drug used for the treatment of infantile colic is simethicone which are more in line with the conclusion that this product is a safe placebo without significant therapeutic effects(4) and other common group of drugs like dicyclomine /dicycloverine which have adverse effects such as drowsiness, constipation, loose stools, and altered consciousness even when given at standard dosages.Hence there is growing need for more effective treatment modality for infantile colic.

The condition Infantile Colic can be correlated with Udarshoola as described in various Ayurvedic classics. In Ayurveda, various treatment modalities have been described by the Acharyas for the management of Udarashoola. One such formulation is Chaturbeeja Arka as mentioned in Ravanakrita Arka prakasha. This formulation possesses Shoolahara, Vatahara, Anulomaka , Deepana-Pachana properties. Due to its palatable nature, rapid onset of action, and efficacy in lower doses, chaturbeeja arka might be more effective in treating infantile colic.

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
21.00 Day(s) 至 6.00 Month(s)(—)
性别
All

入选标准

  • •AGE GROUP 3 WEEKS TO 6 MONTHS INFANTS FULFILLING DIAGNOSTIC CRITERIA.

排除标准

  • •Infants with an acute or chronic local or systemic infection will be excluded Infants with known congenital gastrointestinal anomalies like intestinal obstructions hypertrophied pyloric stenosis etc Children with known acute and chronic bowel disorders like vomiting diarrhea mal-absorptions etc Infants with known Metabolic or Neurological disorder Infants who are currently on other medications that may interfere with study outcome like anti spasmodics analgesics laxatives etc will be excluded.

结局指标

主要结局

There might be significant effect of Chaturbeeja arka orally in the management of Udarshoola (Infantile colic) Measured by changes in FLACC Scale and VAS Scale

时间窗: Minimum one day maximum 3 days

次要结局

  • There might be significant effect of Chaturbeeja arka orally in the management of Udarshoola (Infantile colic)Measured by changes in the Udarashool Parameters(Minimum one day maximum 3 days)

研究者

发起方
KLE Shri B M Kankanawadi Ayurveda Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr SUKANYA MAHADEV SWAMI

KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya

研究点 (1)

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