Role of Ayurveda in Shwasa Roga in children

Phase 3

Completed

• Conditions: Mild intermittent asthma,

• Registration Number: CTRI/2020/06/025913
• Lead Sponsor: Institute for Post Graduate Teaching and Research in Ayurveda

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Study Completion: 2023-07-28
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients of 2 – 16 years of age in either sex 2.
• 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.

Exclusion Criteria

• 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 5.
• 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Partial or complete remission of bronchial Asthma	Baseline 8 weeks and 12 week

Secondary Outcome Measures

Name	Time	Method
Reduction in breathlessness	Baseline 8 weeks and 12 week

Trial Locations

Locations (1)

IPGTRA; 🇮🇳 Jamnagar, GUJARAT, India

IPGTRA

🇮🇳Jamnagar, GUJARAT, India

Dr Sagar Bhinde

Principal investigator

9662512158

sgrbhinde@ayurveduniversity.com