A clinical trial to study the effect of Pankajakasthuri Breath Eazy Mishrit, in patients with cough, cold and breathing difficulties.

Phase 1

Completed

• Conditions: Moderate persistent asthma, (2) ICD-10 Condition: J454||Moderate persistent asthma, The Patients with Bronchial Asthma visiting PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE OUT PATIENT DEPARATMENTS for consultation.,

• Registration Number: CTRI/2016/10/007389
• Lead Sponsor: Pankajakasthuri Ayurveda Medical College and Post Graduate Centre

Brief Summary

This study is a open clinical trial to asses the efficacy of PANKAJAKASTHURI BREATH EAZY MISHRIT in 60 patients with Bronchial Asthma visited the OPD of PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE HOSPITAL from 07.01.15 to 15.08.15. The severity of disease was graded under five scoring scales. The observation and calculations were made on the basis of relevant statistical methods. The primary outcome measure was done at the end of 2nd month and secondary outcome was measured at the end of 4th month, third at the end of 6th month. The observations on the basis of followup was also taken for statistical analysis. The statistical analysis by using paired t test produced the success rate by attaining P<0.001 shows the medicinal value of the product is highly significant in treating the disease- bronchial asthma with high percentage of improvements.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-01
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Both sex with equal distributor with or without rhinitis.
• 3 Mild persistent cases of Asthma (as per WHO GINA Guideline) of duration more than 6 months.
• Asthmatic meet reversibility criteria (15% improvement in FEVI after Beta – 2 agonist inhalation) 5.

Exclusion Criteria

• Mild intermittent, moderate persistent, severe persistent to severe Asthma (As per WHO GINA guidlines of duration more than 6 months) Dyspnoea due to other disease like Left ventricular failure, COPD (Chronic Bronchitis, Emphysema), Upper respiratory tract obstruction, Bronchiectasis, cases of tuberculosis, interstitial lung disease/occupational Lung disease, tropical pulmonary eosinophilia, Lofflers disease & Allergic Bronchopulmonary Aspergillosis etc.
• Diabetes Mellitus and Hypertension.
• Severe renal/Hepatic disease HIV positive cases Lung Cancer Pregnant/lactating mother Patient who need Salbutamol inhaler daily.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
More than 70% of participants had 100% releif Percentage calculation and assessment criteria based on scoring of grading by using the following parameters.	SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS
3Swasa krichrata (Dyspnoea)	SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS
4Ghurghurakam (Wheezing)	SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS
Frequency of swasa vega (Difficulty in respiration)	SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS
2Intensity and duration of attack	SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS
5Kaphashteevanam(Production of cough)	SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS

Secondary Outcome Measures

Name	Time	Method
More than 70% of participants had 100% releif Percentage calculation and assessment criteria based on scoring of grading by using the following parameters.	Frequency of swasa vega (Difficulty in respiration)

Trial Locations

Locations (1)

Pankajakasthuri Ayurveda Medical College and Post Graduate Centre; 🇮🇳 Thiruvananthapuram, KERALA, India

Pankajakasthuri Ayurveda Medical College and Post Graduate Centre

🇮🇳Thiruvananthapuram, KERALA, India

DrGSSREEKUMAR

Principal investigator

09486886362

gssreekumarnair@gmail.com