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临床试验/CTRI/2025/02/080395
CTRI/2025/02/080395尚未招募2 期

An Open labelled Non Randomised Parallel group clinical controlled trial on Saraswata Ghrita ( oral) and Chaturbhadra Kalpa Basti in the management of Global developmental delay (GDD) in Children

State Ayurvedic college and hospital lucknow1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月20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
30
试验地点
1
主要终点
1. Improvement in quality of life in children .

研究概览

简要总结

Global Developmental delay ( GDD ) is one of the most steadily rising complex neuromuscular developmental disorder in past few decades, but there is no certain treatment available in any modalities. Ayurveda is the ray of hope for such kind of  clinical conditions.Therefore, I select this trial. Clinical trial will be done on two group A and B . In group A Saraswata ghrita using route of administration as Paan (Oral route) for 84 day’s without any gap and In Group B Chaturbhadra Kalp Basti (Per rectal route) ,12 day schedule ( 4 sneha vasti in beginning, 4 niruh vasti in mid, 4 sneha vasti in last ). Minimum 30 GDD  diagnosed children, aged 1 to 5 years clinically studies of treatment modules. Each segment of treatment module will be  for 84 day’s. After, each treatment there is a gap of 24  days in group  B, Total duration of trial is 84 days. A follow up will be done after 30 days of complete clinical trial.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Child between age Group of 1-5 yr of either sex are diagnosed GDD 2 .Child / parents willing to participate in the Trial.
  • Children with developmentaldisabilities of both physical and mental ( delayed milestone)
  • Unable to stand , walk, speech, sitting as per age.
  • Child with altered IQ as per age.

排除标准

  • 1.Child of age less then 1 year.
  • and more then 5 years.
  • 2.Child with sever infection, systemic illness like TB.
  • Gastrointestinal disease 3.Child with genetic disorder like down syndrome or any congenital anomalies 4.Child suffering from any muscular dystrophy (DMD) 5.Child having abnormal CT/MRI brain finding with abnormal EEG finding.

结局指标

主要结局

1. Improvement in quality of life in children .

时间窗: After 84th day of trial

2. Improvement in speech/language/Communication/sociability/sensory/cognitive awareness , locomotary disability.

时间窗: After 84th day of trial

次要结局

  • •To Check the efficacy of Saraswata ghrita in the case of GDD.(•To evaluate the role of Chaturbhadra kalp basti in GDD.)

研究者

发起方
State Ayurvedic college and hospital lucknow
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Mamta Chandra

State Ayurvedic college and hospital lucknow

研究点 (1)

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