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临床试验/CTRI/2020/06/025913
CTRI/2020/06/025913已完成3 期

A Comparative Clinical Study of Kantakari Avaleha and Chitrakaharitaki Avaleha on Tamaka Shwasa (Bronchial Asthma) in Children

Institute for Post Graduate Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月7日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Partial or complete remission of bronchial Asthma

研究概览

简要总结

The study design of present clinical trial was open labelled, randomized controlled clinical trial. The clinical study was started after getting approval of IEC (vide ref. - PGT/7/-A/Ethics/2019-2020/3158 dated 30/03/2020). The trial is also registered in CTRI prospectively (CTRI/2020/06/025913 registered on: 1/06/2020). First enrolment was on 26/08/2020 and last patient enrolled on 21/10/2022. During this period, total 104 patients of Tamaka Shwasa have been screened, out of which 100 patients were registered in the study. Among them 80 were completed the trial along with follow-up and 20 patients didn’t complete the trial due to various reasons. In the present clinical trial, subjects were randomly allocated into two groups according to Sequentially numbered opaque sealed envelope (SNOSE). Group A: Kantakari Avaleha and group B: Chitraka Haritaki Avaleha. Drugs were given in below mentioned dose in three divided doses after meal with lukewarm water for a period of 8 weeks with 4 weeks of follow up. After 8 weeks, use of Kantakari Avaleha (Group A) showed statistical significant improvement in all the cardinal symptoms, Agni Bala, PEFR, RR, BHT, Level of Asthma control, ACT and in ACQ; while insignificant changes were seen in all haematological parameters except Total RBC count (which also remains in normal limit only). 

Chitrakaharitaki Avaleha (Group B) showed significant improvement in all the cardinal symptoms, Agni Bala, PEFR, RR, Level of Asthma control, ACT score and in total ACQ; while insignificant changes were seen in all haematological parameters except Basophil count.

On comparison of the groups, significant difference was found in Shwasakashtta, Pinasa, *Krichchhratbhashitam,*ACT and ACQ. (group B is better than group A)

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
2.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Patients of 2 – 16 years of age in either sex
  • Patients having any 4 or more classical symptoms of Tamaka Shwasa.
  • Diagnosed cases of bronchial asthma with at least 3 episodes of symptoms within a year.

排除标准

  • 1 Patients of < 2 year and > 16 years of age 2 Patient came during status asthmaticus 3 Evidence of active pulmonary disease other than asthma 4 Evidence of requirement of intubations for asthma within one month before
  • Patients having unresolved sinus disease or an unresolved upper or lower respiratory tract infection within 3 weeks.
  • Concomitant severe de-compensated systemic disease (cardiovascular, renal, hepatic, endocrine, hematological, neurological, immunological).

结局指标

主要结局

Partial or complete remission of bronchial Asthma

时间窗: Baseline 8 weeks and 12 week

次要结局

  • Reduction in breathlessness(Baseline 8 weeks and 12 week)

研究者

发起方
Institute for Post Graduate Teaching and Research in Ayurveda
申办方类型
Research institution and hospital

研究点 (1)

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