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临床试验/CTRI/2025/03/081839
CTRI/2025/03/081839尚未招募Phase 3 4

Combined effect of Mahathpanchagavya grita internally and abhyanga with Bhunagadi taila on specific areas of body as an add on to anti epileptic drug in the management of Intractable Epilepsy in Children of age group 1-12 years.

Goverment Ayurveda College Thiruvananthapuram1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2025年3月20日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
14
试验地点
1
主要终点
.Parental perception of seizure- frequency, intensity and severity of seizure will be assessed by using Hague seizure severity scale

研究概览

简要总结

Children in the age group 1-12 years, satisfying inclusion criteria will be selected for the study from the OPD of Balaroga Government Ayurveda College Hospital for Women and Children, Poojappura. Informed consent will be taken from the parents of selected participants. Participants will be assessed using Hague seizure severity scale, EEG and quality of life in childhood epilepsy questionnaire. For this study drugs will be prepared as per classical references and will be made available from a GMP certified authorized Institution. The study participants will be given proper preperatory measures to make the participants fit for grita administration. Patient will be given Mahathpanchagavya grita for 60 days in a dose of 3-24ml according to age(calculated using Young’s formula), twice daily in empty stomach at morning and 1 hour before food in the evening with warm water. Abyangam on specific areas(Bregma,inbetween two eyebrows,behind ear,joints of upper and lower limb,palm of both hand,sole of both foot,site of Hridaya and nabhi) will be done twice daily(morning and evening) for a time period of 5 minutes for 60 days.After half an hour taila will be wiped off with clean towel .Participants will be adviced to take AEDs in same dose as they are taking throughout the study. Participants will be assessed before treatment, after treatment and after follow up period using Hagues seizure severity scale. quality of life in childhood epilepsy questionnaire, and EEG. Parents will be instructed to keep a seizure diary also .EEG of the child will be taken before and after study from near by authorized scan centre and will be assessed by co-guide of the study (Paediatric Neurologist.)

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children with intractable epilepsy.
  • Children aged 1-12 years.
  • On conventional AED unaltered for atleast 1 month as per the direction of paediatrc neurologist.

排除标准

  • Children with metabolic disorders
  • Children with recurrent respiratory tract infection.
  • Children with Developmental epileptic encephalopathy.

结局指标

主要结局

.Parental perception of seizure- frequency, intensity and severity of seizure will be assessed by using Hague seizure severity scale

时间窗: Hague seizure severity scale | before and after study

次要结局

  • Electroencephalographic changes will be observed by Electroencephalogram.(3.Changes in quality of life will be assessed by Quality Of life in Childhood Epilepsy questionnaire)

研究者

发起方
Goverment Ayurveda College Thiruvananthapuram
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Arya M

Goverment Ayurveda College

研究点 (1)

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